For office use only: REC Protocol No Date recd:

APPLICATION FOR ETHICAL APPROVAL

Please tick the Committee you are applying to:

Sub-Committees (RESC)
PNM RESC
(Psychiatry, Nursing & Midwifery)

SSHL RESC
(Social Sciences, Humanities & Law High Risk)

BDM RESC (Health)

(Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences)

Research Ethics Panels (REP)

For SSPP, Humanities and Law (non-high risk only)

E&M REP
(Education & Management)

GGS REP
(Geography, Gerontology, SCWRU)

Humanities REP

Law REP

War Studies Group REP

Notes for all applicants

Please read the guidelines before filling out the application form and refer to the specific guidelines about each section when filling in the form. (http://www.kcl.ac.uk/research/ethics/applicants/) Refer to the Guidelines for the submission deadlines for your Committee and the number of copies to submit (including electronic versions if applicable). All applications should be submitted by 5pm on the deadline day. All Sub-committee applications should be submitted to the Research Ethics Office, 5.11 Franklin Wilkins Building, (Waterloo Bridge Wing), Waterloo Campus, Kings College London, Stamford Street, London SE1 9NH. All Research Ethics Panel applications should be submitted to SSPP Ethics Administrator, K0.58 Ground Floor Strand Building, King's College London, The Strand, London WC2R 2LS.
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SECTION A TO BE COMPLETED BY ALL APPLICANTS

1. APPLICANT DETAILS 1.1 RESEARCHER Researchers Name: Professor Graham Thornicroft Researchers Department & School: Health Service and Population Research Department Status:
Undergraduate Taught Postgraduate MPhil / PhD/ Specialist Doctorate Staff Research

If Student: Name of course/qualification: If Staff: Researchers Post: Professor Of Community Psychiatry, Head Of Health Service And Population Research Department 1.2 CONTACT DETAILS Email: graham.thornicroft@kcl.ac.uk Telephone number: + 44 (0) 20 7848 0736 Address: Health Service and Population Research department, Institute of Psychiatry, King's College London, de Crespigny park, London, SE5 8AF 1.3 SUPERVISOR - COMPLETE FOR ALL STUDENT PROJECTS (Including PhD) Name of Supervisor: Supervisors Post: Supervisors Department (if different to student): Supervisors email address: 1.4 OTHER INVESTIGATORS, COLLABORATORS, ORGANISATIONS List any other investigators/collaborators involved with the study, and ensure that their role (e.g. collaborator, gatekeeper) and responsibilities within the project are explained. You should include any draft/preliminary approach letters to gatekeeper organisations and confirm that you will have permission letters available for inspection if requested for audit purposes. NB: For other investigators/collaborators clarify if their employer is not Kings College London. Professor Norman Sartorius (Professor; President of the Improvement of Mental Health Programmes): Principal Investigator. Professor Sartorius manages the study and advises on study design, implementation, analysis and dissemination. Dr Diana Rose (Service User Evaluation And Social Scientist): Investigator. Dr Rose has been involved in the study design and will be involved in analysing qualitative aspects of the project. Furthermore, Dr Rose is an expert in service user-led research, and has been involved in ensuring service user representation throughout the project. Dr Nisha Mehta (Trainee Psychiatrist): Investigator. Dr. Mehta has been involved in the study design and will advise on, implementation, analysis and dissemination. Ms. Estelle Malcolm (Research Worker): Coordinator. Ms. Malcolm will manage the study, including coordinating data collection, analysis and dissemination.

2. PROJECT DETAILS
2.1 Project Title

Inpatient Discharge: Experiences and Analysis (IDEA)

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2.2 Projected Start Date of Project This should be when you intend to start work with participants 2.3 Expected Completion Date of Project 2.4 Sponsoring Organisation Your sponsor will be assumed to be Kings College London unless stated otherwise. NB: Do not put N/A 2.5 Funder (e.g. self-funded, Kings College London, ESRC, AHRB, EU)

March March 2012 Association for the Improvement of Mental Health Programmes and Kings College London self funded

2.6 DOES THE STUDY INVOLVE HUMAN PARTICIPANTS OR FOR OTHER REASONS REQUIRE ETHICAL APPROVAL? NB: It may be the case that research does not involve human participants yet raises other ethical issues with potential social or environmental implications. In this case you should still apply. Please consult with the Research Ethics Office (rec@kcl.ac.uk) if in doubt.
Yes No

2.7 OTHER INFORMATION RELATING TO RISK Will the study place the researcher at any risk greater than that encountered in his/her daily life? (e.g. interviewing
alone or in dangerous circumstances, or data collection outside the UK).

Yes

No

If applicable: Does the study involve the using a Medical Device outside of the CE mark approved method of use? (see
guidelines) If you are using a medical device off label (outside of the approved method of use) then a risk assessment needs to be completed. For further information on medical devices see the Medicines and Healthcare Products Regulatory Agency webpages: http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/index.htm and http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/GuidanceontheECMedicalDevicesDirectives/index.htm.

Yes

No

If you have ticked yes to either of the above: Yes, and I have completed a risk assessment which has been co-signed by the Head of Department/ I have discussed the risks involved with my supervisor or Head of Department and agreed a strategy for minimising these risks. 2.8 OTHER PERMISSIONS, ETHICAL APPROVALS & CRIMINAL RECORDS BUREAU CLEARANCE REQUIRED ANOTHER REVIEWING BODY/PERMISSIONS - Are any other approvals by another reviewing body (including other ethics committees, gatekeepers and peer review) required? If yes, give details and say when these will be obtained. If they have already been obtained you should provide a copy of the approval with the application otherwise you will need to supply it when ready. YES NO commences. Each Investigator will seek ethical approval with the relevant ethics body in their own country before any d

CRIMINAL RECORDS BUREAU - Is Criminal Records Bureau clearance necessary? If so, please confirm that clearance will be sought before commencement of the project. YES NA

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2.9 HUMAN TRIALS QUESTIONNAIRE Does a human trials questionnaire need to be submitted? YES NO (http://kcl.ac.uk/about/structure/admin/finance/staff/insurance/trials.html) If yes, confirm that the Human Trials Questionnaire will be submitted prior to the start of the study. YES

3. AIMS, OBJECTIVES & NATURE OF STUDY The purpose of the IDEA study is to explore the experiences of patients in 13 different countries (not in the UK) and 24 sites who have received in-patient treatment by interviewing them on their discharge date. The study aims to use the data collected from the interviews to: a) propose the use of the questionnaire for routine use in mental health institutions b) develop versions of the interview that could be used in other types of services c) publish the results of the multi-site, international comparative study of user satisfaction d) carry out a follow-up study of the views of patients about the value of services, including the impact that patients assessments and suggestions may have had on the service where the interview took place. 4. STUDY DESIGN/METHODOLOGY, DATA COLLECTION & ANALYSIS

Provide a brief outline of the step-by-step procedure of your proposed study, in no more than 1 page where possible. (An example of a flow chart that could be used is in the Guidelines.)
The evaluation of mental health services relies heavily on data recorded in the health service system and on information received from health care personnel. The IDEA project explores ways of ensuring that patients views and suggestions concerning care become known and used in the improvement of mental health care. It is proposed to explore the experience of patients who have been treated in a mental health institution (eg hospital or department of psychiatry) by interviewing patients at the point of their departure from the institution. The design of the study will be in a two phase approach, of which phase one which was a service evaluation has occurred (therefore ethical approval is not needed for phase one, however its design will be outlined below). The role of the Investigators at the Institute of Psychiatry is to coordinate the study and analyse the results so that international comparisons can be made. All data collection will take place outside of the UK and collaborators will seek the relevant ethical approval at their institutions. Phase 1 This stage of the study was a pilot and a feasibility stage for phase 2. Ten sites from eight different countries were involved in the pilot phase. Psychiatrists at each site gained ethical approval from the relevant ethics body. Semi-structured interviews were carried out with 10 to 30 consenting participants. The data collected was sent to the Institute of Psychiatry, Kings College London for analysis and results will be sent back to each site so that they can be immediately usable to improve current practice at each of the sites. Phase 2 This stage of the study will involve 24 sites from 13 different countries (Azerbaijan, Hungary, Italy, Nigeria, Romania, Serbia, Uganda, Ukraine, Germany, Croatia, Ireland, The Netherlands, Macedonia). After gaining ethical approval from the relevant ethics body, Psychiatrists from each site will interview 30 consenting patients on their date of discharge. Depending on the resources available, the Psychiatrist at each site will offer the opportunity to participate in the study to every patient on discharge until the target of 30 is reached. If this is not possible because too many patients are
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discharged in one day, a random selection of patients will be interviewed. The Psychiatrists will have been involved in local service delivery but not directly involved with the care of the patients they interview. If they have directly been involved in the care of the patients they will interview, another member of staff will carry out the interview. Interviews will take place over a three month period from the time the Psychiatrist receives the study materials. The areas to be included in the semistructured interviews are: (1) Overall do you feel your stay in hospital was beneficial? (2) Satisfaction with the staff (3) Do you feel that you came to any harm during your stay in hospital (through other patients and/or members of the staff)? (4) Were your individual preferences and rights taken into account? (5) Was your right to confidentiality observed? (6) What are the main improvements that should be made to this service? Participants will rate their answers on a Visual Analogue Scale and notes of their answers will be made during the interview. Interviews will be carried out in the preferred language of the patient and translated into English to enable comparative analysis between centres. Psychiatrists at each site will be provided with DVDs outlining examples of a good interview and interview techniques. Demographic information will also be collected for each participant such as age, sex and level of education. The Psychiatrist at each site will collect information about the psychiatric institution to help further determine factors that correlate/contribute to a patients inpatient experience. The information that will be recorded includes; environmental aspects of the psychiatric institution such as size, location and accessibility; staff ratio to residents; organizational factors such as the number of beds and available facilities; and complaints procedures. Analysis Quantitative analysis will take the form of an aggregation per centre of results on the Visual Analogue Scale (VAS) for each question in the proforma with a view to comparing between centres. The VAS will also be analysed by demographic indices within centres (e.g. gender, age) to see whether different groups have different experiences. The notes made of the patients answers to questions will form the qualitative data set. It will be analysed thematically, both within and between centres, identifying core themes for each domain and core themes for the protocol as a whole. Anonymised quotations will be used to illustrate themes. We will use the data collected about the institution to gain a better understanding of the size, structure and staffing of the institutions which are included in the study, which will help us with our observations about inpatient experiences by putting them in context. This will also help us to take into account variations in the type of institutions involved in the study and therefore in our wider recommendations. 5. PARTICIPANTS TO BE STUDIED 5.1 PROJECTED NUMBER OF PARTICIPANTS

Number: 720

If applicable: How many will be male

and female

Justification for the sample size: 24 sites have been enrolled to be involved in the IDEA study and each site will interview 30 patients. It was decided that 30 patients was a feasible number that each Psychiatrist could interview within a three month time period. Also central limit theorem proposes that with sample sizes of at least 30 it can be assumed that the sampling distribution is approximately normal.
If an upper age limit is needed you must provide a justification. The institutions that will be enrolled in the study are adult inpatient facilities; therefore patients are over the age of 18. Upper Age Limit: N/A Lower age limit: 18 5.2 SELECTION CRITERIA Participants will be those who have received inpatient treatment at one of the sites in the study. 5.3 RECRUITMENT

Describe how participants will be (i) identified and (ii) approached. i) Depending on the resources available, the Psychiatrist at each site will offer the opportunity to participate in
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When the date of discharge is known the psychiatrist will approach the patient with the study materials and explain the purpose of the study and if they would consent to participate. Psychiatrists will inform the patient that they will be conducting the interview and arrange a time for it to take place in a quiet place where they can talk confidentially. The Psychiatrists will have been involved in local service delivery but not directly involved with the care of the patients they interview. If the Psychiatrist has been directly involved in the care of the patient they will interview, another member of staff will carry out the interview. The interviewer/s will have viewed the DVD on interviewing techniques, had training on the aims of the study and had training on the use of the IDEA project patient interview questionnaire form 5.4 LOCATION ii)

State where the work will be carried out e.g. public place, in researchers office, in private office at organisation. The interviews will be carried out in a private room where participants can speak confidentially in the institution where they were an inpatient.
6. ETHICAL CONSIDERATIONS 6.1 INFORMED CONSENT Describe the process you will use to ensure your participants are freely giving fully informed consent to participate. This will always include the provision of an information sheet and will normally require a consent form unless it is a purely selfcompletion questionnaire based study or there is a justification for not doing so (this must be clearly stated). Templates for these are at the end of this document and they should be filled in and modified where necessary. The Psychiatrist at each site will ask patients once their discharge date is known whether they would like to participate in the IDEA study on their discharge day. As part of the recruitment process participants will be assessed by the Psychiatrist in terms of their capacity to participate in the study. The Psychiatrists will have been trained in assessing capacity so will be experienced in being able to determine whether participants are able to make informed consent. Before enrolment in the study all participants will be informed about the aims of the IDEA study. Interested participants will be provided with an information sheet and consent form. The Psychiatrist will ensure that the potential participant can understand and retain the information provided by the information sheet and give them the opportunity to ask questions. The Psychiatrist will assess whether the potential participant is able to process the information provided and is able to come to an informed decision that they can communicate to the Psychiatrist. Verbal responses that potential participants make during discussions about the research and availability of when they can be interviewed will enable the Psychiatrist to determine if individuals are able to process the given information. If the Psychiatrist has any doubts regarding capacity or there has been a change in circumstance relating to capacity after informed consent has been given, such as there being a change in an individuals mental state, the interview will not take place. If needed the Psychiatrist can contact the Principal Investigator for advice. The Principal Investigator is a Consultant Psychiatrist with working knowledge of the Mental Capacity Act (2005) so will be equipped to answer questions regarding the topic of informed consent. 6.2 RIGHT OF WITHDRAWAL (Participants should be able to withdraw from the research process at any time and also should be able to withdraw their data if it is identifiable as theirs and should be told when this will no longer be possible (e.g. once it has been included in the final report). Please describe the exact arrangements for withdrawal from participation and withdrawal of data depending on your study design). The interviews will contain some patient demographic information but no names will be recorded and the information about participants in the study will be strictly anonymised. If a participant wishes to withdraw from the study they are free to do so and their information will then not be used in the analysis. However once the data has been collated and analysed as a group it will no longer be possible for participants to withdraw and they will be informed of this during the consent process. Participants will have the contact details of the study collaborator in their own country, who they may contact at any time if they have concerns about their participation in the study. 6.3 RISK CHECKLIST Where you have ticked Yes on the risk checklist, provide details of relevant qualifications and experience with reference to those sections. This must include the researcher and/or supervisor as well as other collaborators (if
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applicable) involved in those sections marked as presenting risk. (Do not submit a c.v.) Prof. Thornicroft is a Consultant Psychiatrist and has extensive experience of research with human participants. Prof. Thornicroft has led or collaborated with these relevant research projects:

The END study developing and piloting the new MICA (Mental Illness: Clinicians Attitudes) scale to measure attitudes of clinicians to people with mental illness, underway. Within END, a controlled intervention study with trainee psychiatrists designed to reduce stigmatisation. The INDIGO study, which looked at the global pattern of anticipated and experienced discrimination against people with schizophrenia. (Thornicroft G, Brohan E, Rose D, Sartorius N, 2009) completed. Use of this pilot scale DISC within the INDIGO study to assess the cross-national experiences of discrimination by people with schizophrenia in 28 countries worldwide, also using qualitative data on reported discrimination worldwide, initial field-testing complete. The GAMIAN project, an evaluation of reported self-stigma among people with anxiety-related disorders in 15 EU countries, underway.

You must also specifically address the ethical issues raised from those sections here. All study investigators are qualified psychiatrist who have been through relevant training in their own countries and have a code of conduct which they must abide by. The only relevant ethical issue that could arise from this study is the possible disclosure of professional misconduct of a member of staff within an institution that a participant was an inpatient. If evidence of professional misconduct is uncovered requiring action the participant will: a) First be asked whether they consent for this information to be disseminated to the relevant complaint body (depending on the nature of the disclosure this could be the police, the hospital complaints body, the head of service / clinical director equivalent). b) If possible, the participant would be asked if anyone is already aware of this, and find out who e.g. social services, the police, their mental health professional. c) The interview would end. d) A member of the IDEA research team would be contacted immediately and the situation would be explained to them and they would provide advice as to what further action should be taken. NB: If you ticked yes to any point in E i -vi of the checklist, you must also complete and submit Section B of the application form. 6.4 OTHER ETHICAL ISSUES Please consider whether there are other ethical issues you should be covering here. Further, if applicable, please also add the professional code of conduct you intend to follow in your research. http://www.kcl.ac.uk/research/ethics/training/codes.html

6.5 BENEFITS & RISKS Please describe any expected benefits and risks to the research participant. There are no direct benefits to participants personally being involved in the study. However, we hope there will be benefits to other people in the future who will be treated in the institutions that are part of the study as well as those which are not. The recommendations made by patients for improvements to psychiatric institutions will help improve inpatient care in the future. The interview questions are not intended to be embarrassing or harmful in any way, however if at anytime participants feel
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uncomfortable or distressed and not able to continue, the interview can be stopped at any point. If participants feel the study has harmed them in anyway they will be provided with the contact details of Kings College London and the collaborator in their own country to gain advice and information if needed. 6.6 CRIMINAL OR OTHER DISCLOSURES REQUIRING ACTION Is it possible that criminal or other disclosures requiring action (e.g. evidence of professional misconduct) could be made during this study? YES NO
If yes, detail what procedures will be put in place to deal with these issues. The Information Sheet should make it clear under which circumstances action may be taken by the researcher.

Strictly anonymised demographic information would be collected about each participant. The Psychiatrist or member of staff at the institution will ensure participants that whatever they disclose, no names of staff or other patients will be recorded and that the suggestions about the services will be made available to the chief of the service in a format which will not enable identification of individuals taking part. If evidence of professional misconduct is uncovered requiring action the participant will: a) First be asked whether they consent for this information to be disseminated to the relevant complaint body (depending on the nature of the disclosure this could be the police, the hospital complaints body, the head of service / clinical director equivalent). b) If possible, the participant would be asked if anyone is already aware of this, and find out who e.g. social services, the police, their mental health professional. c) The interview would end. d) A member of the IDEA research team would be contacted immediately and the situation would be explained and advice would be sought as to what further action should be taken.

7 FINANCIAL INCENTIVES, EXPENSES AND COMPENSATION 7.1 Will travelling expenses be given? If yes, this should be stated on the Information Sheet YES NO 7.2 Is any reward, apart from travelling expenses to be given to participants? If yes, please provide details and a justification for this. It is recommended that participants are informed of the compensation on the information sheet. YES NO

7.3 Is the study in collaboration with a pharmaceutical company or an equipment or medical device manufacturer? If yes, please give the name of the company and indicate what arrangements exist for compensating patients or
healthy volunteers for adverse effects resulting from their participation in the study (in most cases, the Committee will only approve protocols if the pharmaceutical company involved confirms that it abides by APBI (The Association of the British Pharmaceutical Industry) guidelines. A copy of the indemnification form (Appendix C) should be submitted with the application.

YES

NO

7.4 No fault compensation scheme If your study is based in the UK you must offer the No-fault compensation scheme to
participants unless there is a clear justification for not doing so (if this is the case this must be stated and you should bear in mind that the Sub-Committee reserves the right to make this a condition of approval).

YES, I am making the scheme available to participants NO, the study is based outside the UK and so the scheme is not applicable
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NO, the study is within the UK but the No-fault compensation scheme is not offered for the following reason:

8. DATA PROTECTION, CONFIDENTIALITY, AND DATA AND RECORDS MANAGEMENT 8.a. Confirm that all processing of personal information related to the study will be in full compliance with the Data Protection Act 1998 (DPA) including the Data Protection Principles).
If you are processing any personal information outside of the European Economic Area you must explain how compliance with the DPA will be ensured.

YES NO 8b. What steps will be taken to ensure the confidentiality of personal information? Give details of anonymisation
procedures and of physical and technical security measures. Please note to make data truly anonymous all information that could potentially identify a participant needs to be removed in addition to names.

A Master File will be set up at the beginning of the study at the Institute of Psychiatry and will be password-protected. All documents (consent forms and questionnaires) will be kept in a secure, locked filing cabinet, and all folders will be accurately labelled at each site involved in the study. Each site will make a photocopy of all study data and return the originals to the Institute of Psychiatry by Courier. When we contact the site to confirm safe receipt of the data the copies they made will be destroyed, except for a copy of the patient consent form which will be stored securely. Psychiatrists will not be collecting any identifiable information such as date of birth or name, so patients can only potentially be indentified if they ask for their data to be removed and can provide their age, sex, length of stay and date of discharge, which is the information collected at the beginning of the interview. Any data files, successive versions of the data, or analysis, either computerised or in hard copy made at Kings College London or any of the site will be either password-protected or kept in a secure locked filing cabinet respectively. All data files will be kept anonymous and held confidentially in line with the UK Data Protection Act 1998.

8c. Who will have access to personal information relating to this study? Confirm that any necessary wider disclosures
of personal information (for instance to colleagues beyond the study team, translators, transcribers auditors etc) have been properly explained to study participants.

Strictly anonymised demographic information would be collected about each participant. Study participants will only have their questionnaire forms (which will not contain any identifiable information) viewed by their interviewer where they were an inpatient and the team at Kings College London. The interviewer will reassure participants that disclosures made will be strictly confidential unless they have given information relating to a criminal offence or abuse that has occurred at the institution which will be dealt with as outlined in 6.6. Names of staff or other patients will not be recorded and patients will be informed that the suggestions about the services that they make will be made available to the chief of the service in a format which will not enable identification.

8d. Data and records management responsibilities during the study. The Principal Investigator is the named
researcher for staff projects and the supervisor for student projects.

I confirm that the Principal Investigator will take full responsibility for ensuring appropriate storage and security for all study information including research data, consent forms and administrative records and that, where appropriate, the necessary arrangements will be made in order to process copyright material lawfully. YES NO

8e. Data management responsibilities after the study. State how long study information including research data, consent forms and administrative records will be retained, what format(s) the information will be kept in and where the data will be stored. For example, where within Kings College London? (http://www.kcl.ac.uk/iss/igc/tools/researchers.html) All data files will be kept anonymous and held confidentially in line with the UK Data Protection Act 1998. A Master File will be set up at the Institute of Psychiatry at the beginning of the study and will be password-protected. All documents (consent forms and questionnaires) will be kept in a secure, locked filing cabinet, and all folders will be accurately labelled at each site involved in the study. Each site will make a photocopy of all study data and return the originals to the Institute of Psychiatry by Courier. When we contact the site to confirm safe receipt of the data the copies they made will be destroyed except for the patient consent form which will be kept and stored securely for 7 years as it contains patient identifiable
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information. Any data files, successive versions of the data or analysis, either computerised or in hard copy will be either password-protected or kept in a secure locked filing cabinet respectively at the Institute of Psychiatry. The dissemination of the results of the IDEA study or possible subsequent studies has no definitive end, therefore the anonymised data files will be retained indefinitely and will remain password-protected. In addition, confirm whether the storage arrangements comply with the Data Protection Act 1998 and the College guidelines. YES NO Will data be archived for use by other researchers? NO YES (in anonymised form)
information sheet. If you intend to share anonymised data with other researchers, you must make this clear on the

YES (in identifiable form following the guidance below) Will any personal information related to this study be retained and shared in unanonymised form? If you tick yes you must YES
ensure that these arrangements are detailed in the Information Sheet and that participant consent will be in place.

NO

9. AUTHORISING SIGNATURES 9.1 RESEARCHER/APPLICANT

I undertake to abide by accepted ethical principles and appropriate code(s) of practice in carrying out this study. The information supplied above is to the best of my knowledge accurate. I have read the Application Guidelines and clearly understand my obligations and the rights of participants, particularly in so far as to obtaining valid consent. I understand that I must not commence research with human participants until I have received full approval from the ethics committee. Signature Date. 9.2 SUPERVISOR AUTHORISATION FOR STUDENT PROJECTS (including PhD) I confirm that I have read this application and will be acting as the student researchers supervisor for this project. The proposal is viable and the student has appropriate skills to undertake the research. The Information Sheet and recruitment procedures for obtaining informed consent are appropriate and the ethical issues arising from the project have been addressed in the application. I understand that research with human participants must not commence without full approval from the ethics committee.
If applicable:

The student has read an appropriate professional code of ethical practice The student has completed a risk assessment form
Name of Supervisor: Signature 9.3 MEDICAL SUPERVISION (if appropriate see the Guidelines) Name of Medical Supervisor: Medical Supervisors MDU/MPS (or other insurance provider) number: Signature of Medical Supervisor: .
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Date

Date..

10

10. INFORMATION SHEET AND CONSENT FORM

Remember to submit your information sheets for participants and consent form (if necessary) with your application. Failure to do so will cause delays to your applications. The information sheet for participants should be composed according to the guidelines. The text in red should be deleted or modified as appropriate. If the language in the template is not suitable for your intended participant group it can be modified. There is also a template consent form that can be used. Please refer to the guidelines for further information on how these documents should be used.

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TheIDEAProject InpatientDischarge:ExperiencesandAnalysis AnInternationalCollaborativeStudy

PrincipleInvestigators ProfessorNormanSartorius President AssociationfortheImprovementofMentalHealthProgrammes 14CheminColladon 1209Geneva Switzerland ProfessorGrahamThornicroft ProfessorofCommunityPsychiatry HeadofHealthServiceandPopulationResearchDepartment InstituteofPsychiatry,King'sCollegeLondon DeCrespignyPark,LondonSE58AF UnitedKingdom TABLEOFCONTENTS DOCUMENT1:EXECUTIVESUMMARY&HEADOFSERVICECONSENTFORM DOCUMENT2:COPYOFEXECUTIVESUMMARY&HEADOFSERVICECONSENTFORM DOCUMENT3:IDEAPROJECTPROTOCOL:HOWTOCONDUCTTHESTUDY DOCUMENT4:PATIENTINFORMATIONSHEET DOCUMENT5:SCRIPTFORCONSENTINGPATIENTS DOCUMENT6:PATIENTCONSENTFORM DOCUMENT7:IDEAPROJECTDATAPART1(INSTITUTIONINFORMATION) DOCUMENT8:IDEAPROJECTDATAPART2(PATIENTINTERVIEWQUESTIONNAIREFORM) DOCUMENT9:IDEAPROJECTDATAPART3(ADDITIONALINFORMATION) DOCUMENT10:QUICKREFERENCEGUIDE:IDEAPROJECTCHECKLISTFORRESEARCHERS DOCUMENT11:HOWTORETURNDATA&STUDYCOORDINATORCONTACTDETAILS ALSOENCLOSED 2COPIESOFDVDCONTAININGINFORMATIONABOUTTHEIDEAPROJECTANDANEXAMPLEOFHOW TOCARRYOUTAGOODINTERVIEW

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DOCUMENT1 IDEAPROJECT:InpatientDischarge:ExperiencesandAnalysis AnInternationalCollaborativeStudy EXECUTIVESUMMARY&INSTITUTIONALCONSENTFORM (TOBESIGNED&RETAINEDBYHEADOFPSYCHIATRICSERVICE)

Theevaluationofmentalhealthservicesreliesheavilyondatarecordedinthehealthservicesystemandon information received from health care personnel. The IDEA project explores ways of ensuring that patients viewsandsuggestionsconcerningcarebecomeknownandusedintheimprovementofmentalhealthcare.It is proposed to explore the experience of patients who have been treated in a mental health institution (eg hospital or department of psychiatry) by interviewing patients at the point of their departure from the institution. Theinterviewswillbesemistructuredi.e.whilethethemesthatshouldbetoucheduponintheinterview aresetitwillbeuptothepatientandtheinterviewertofindthebestwaytoprovideinformationaboutthe itemsincludedintheinterview.Theinterviewsshouldtakenolongerthan2030minutestocomplete. Thestudyaimstousetheexperiencegainedintheinterviewsforseveralpurposes:a)toproposetheuseof thequestionnaireforroutineuseinmentalhealthinstitutions;b)todevelopversionsoftheinterviewthat could be used in other types of services; c) publish the results of the multi site, international comparative study of user satisfaction; and d) carry out a follow up study of the views of patients about the value of servicesincludingtheimpactthatpatientsassessmentsandsuggestionsmayhavehadontheserviceabout whichtheinterviewstookplace.Thestudyinvestigatorsareyoungpsychiatristsfromseveralcountrieswho haveparticipatedinrecentcoursesonleadershipandprofessionalskills. Itisproposedtointerviewapproximately30patientsperinstitutiononthepointofdischargefromhospital.In addition to the questionnaire for the interview with the patient there is a questionnaire to describe the institution and a brief description of the person(s) carrying out the interviews. Strictly anonymised demographic information would be collected about each participating patient and participants of the study wouldensurethattheheadsoftheservicesfromwhichtheusersaredischargedunderstandthatnonamesof stafforotherpatientswillberecordedandthatthesuggestionsabouttheserviceswillbemadeavailableto thechiefoftheserviceinaformatwhichwillnotenableidentificationofindividualstakingpart.Thechiefsof servicewouldbegivenanopportunitytocommentonmanuscriptsofpublicationsoftheresultsofthestudy. ThescientificcoordinationofthestudyanddataanalysiswouldbecarriedoutattheInstituteofPsychiatry, KingsCollegeLondon. ThePrincipleInvestigatorsofthestudyareProfessorNormanSartorius,PresidentoftheAssociationforthe ImprovementofMentalHealthProgrammes,Geneva,SwitzerlandandProfessorGrahamThornicroft,Health ServicesandPopulationResearchDepartment,InstituteofPsychiatry,KingsCollege,London.

IAGREETHAT(nameofinstitution)________________________________________mayparticipate intheIDEAProject Signed___________________________________Date___________ PrintName&Title________________________________________________

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DOCUMENT2COPYFORRESEARCHCOLLABORATORpleaseretainfor yourrecords IDEAPROJECTEXECUTIVESUMMARY&INSTITUTIONALCONSENTFORM (TOBESIGNEDBYHEADOFPSYCHIATRICSERVICE)

Theevaluationofmentalhealthservicesreliesheavilyondatarecordedinthehealthservicesystemandon information received from health care personnel. The IDEA project explores ways of ensuring that patients viewsandsuggestionsconcerningcarebecomeknownandusedintheimprovementofmentalhealthcare.It is proposed to explore the experience of patients who have been treated in a mental health institution (eg hospital or department of psychiatry) by interviewing patients at the point of their departure from the institution. Theinterviewswillbesemistructuredi.e.whilethethemesthatshouldbetoucheduponintheinterview aresetitwillbeuptothepatientandtheinterviewertofindthebestwaytoprovideinformationaboutthe itemsincludedintheinterview.Theinterviewsshouldtakenolongerthan2030minutestocomplete. Thestudyaimstousetheexperiencegainedintheinterviewsforseveralpurposes:a)toproposetheuseof thequestionnaireforroutineuseinmentalhealthinstitutions;b)todevelopversionsoftheinterviewthat could be used in other types of services; c) publish the results of the multi site, international comparative study of user satisfaction; and d) carry out a follow up study of the views of patients about the value of servicesincludingtheimpactthatpatientsassessmentsandsuggestionsmayhavehadontheserviceabout whichtheinterviewstookplace.Thestudyinvestigatorsareyoungpsychiatristsfromseveralcountrieswho haveparticipatedinrecentcoursesonleadershipandprofessionalskills. Itisproposedtointerviewapproximately30patientsperinstitutiononthepointofdischargefromhospital.In addition to the questionnaire for the interview with the patient there is be a questionnaire to describe the institution and a brief description of the person(s) carrying out the interviews. Strictly anonymised demographic information would be collected about each participating patient and participants of the study wouldensurethattheheadsoftheservicesfromwhichtheusersaredischargedunderstandthatnonamesof stafforotherpatientswillberecordedandthatthesuggestionsabouttheserviceswillbemadeavailableto thechiefoftheserviceinaformatwhichwillnotenableidentificationofindividualstakingpart.Thechiefsof servicewouldbegivenanopportunitytocommentonmanuscriptsofpublicationsoftheresultsofthestudy. ThescientificcoordinationofthestudyanddataanalysiswouldbecarriedoutattheInstituteofPsychiatry, KingsCollegeLondon. ThePrincipleInvestigatorsofthestudyareProfessorNormanSartorius,PresidentoftheAssociationforthe ImprovementofMentalHealthProgrammes,Geneva,SwitzerlandandProfessorGrahamThornicroft,Health ServicesandPopulationResearchDepartment,InstituteofPsychiatry,KingsCollege,London.

IAGREETHAT(nameofinstitution)________________________________________mayparticipate intheIDEAProject Signed___________________________________Date___________ PrintName&Title________________________________________________ COPYFORLOCALSTUDYCOLLEAGUE/INVESTIGATORpleaseretainthiscopyforyourrecords andreturnaphotocopyofthisformwiththestudydata.

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DOCUMENT3 IDEAPROJECTPROTOCOL: HOWTOCONDUCTTHESTUDY THE INFORMATION IN THIS DOCUMENT IS PRIMARILY INTENDED TO AID AIMOFTHE RESEARCH COLLABORATORS IN LOCAL CENTRES IN PLANNING, SETTING UP, STUDY CARRYINGOUTTHESTUDYANDARRANGINGFORRETURNOFSTUDYDATATO The aim of BEANALYSEDATTHEINSTITUTEOFPSYCHIATRY,KINGSCOLLEGE,LONDON thisstudyisto exploretheexperienceofpeoplewhohavebeentreatedasinpatientsinamentalhealthsetting(eg hospitaldepartmentofpsychiatry)byinterviewingpatients,usuallyonthedayofdischarge. PLANNING/STEPSTOTAKETOPREPAREFORPARTICIPATION 1. ApproachtheheadofinstitutiontoaskforpermissiontocarryouttheIDEAproject.Please show them Document 1 and allow them to read any of the documents contained in this protocoltohelpthemdecidewhethertogivetheirconsentforyoutocarryoutthestudyin yourproposedinstitution. 2. IfyourheadofinstitutionagreestoallowtheIDEAprojecttogoaheadpleaseaskhim/herto sign the consent forms at the bottom of Document 1 and Document 2. Leave the signed Document 1 with the head of institution to retain in their records and keep a copy of the signedDocument2inyourownrecords.PleasemakeacopyofDocument2andreturnitto thestudycoordinatorwithyourdata. 3. Approach your local ethics committee or equivalent to obtain the appropriate ethical approval to carry out the study. The interviews will contain some patient demographic information but no names will be recorded and the information about participants in the study will be strictly anonymised. The aggregated results of the institution will be made available to the head of service. You may find the information in Document 4 (patient informationsheet)usefulindraftingyourethicsapprovalapplication. 4. You will need to obtain informed consent from each patient who participates in this study. You will need to translate the text of the patient information sheet (Document 4) into the patientsownlanguageandgiveittothepatient.Youwillalsoneedtodiscussthestudywith thepatient.Wehaveprovidedasuggestedscriptthatyoucouldreadouttothepatientin Document 5 (in the patients own language). This contains all the information the patient needsandwillhelpthemmakeaninformeddecision. 5. Itisimportantthatthepatientsignsaconsentformtoindicatetheirwillingnesstoparticipate inthestudy.1copyofthisformisprovidedinDocument6.Pleaseaskthepatienttosignthis copy and then make 2 further photocopies. One copy is to stay in the patients notes. The secondcopyisforyoutokeepinyourrecords.Youwillneedtostorethissecurelyfor7years asitcontainspatientidentifiableinformation.Itmustthenbedestroyed.Thethirdcopyisto bereturnedwiththestudydatatobekeptwiththestudycoordinatorsinLondon. CARRYINGOUTTHESTUDYSAMPLINGMETHOD
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 1. Weaskthatyouinterview30patientsonthedayofdischargefromtheward.Theinterview shouldbepreferablydonebyamemberofstaffwhowasnotdirectlyinvolvedinthecareof thepatientwhileinhospital.Iftheinterviewerthereforecannotbeyourselfthenpleaseaska seniorclinicalcolleague(doctor,seniornurseetc)tocarryouttheinterview.Thismaymean that the person carrying out the interviews changes during the study. The interviewer/s shouldhavehadthechancetoviewtheDVD,hadtrainingontheaimsofthestudyandhad trainingontheuseoftheIDEAprojectpatientinterviewquestionnaireform(Document8). 2. Depending on the resources available each institution should offer the opportunity to participateinthestudytoeverypatientondischargeuntilthetargetof30isreachedovera threemonthperiods.Thismaynotbepossiblebecausetoomanypatientsaredischargedat anyonetimeforyoutobeabletokeepup.Ifthishappensyoushouldinterviewarandom selectionofpatients(egeverysecondpatientoreverythirdpatient).Youshouldstatewhat youhavedoneinDocument9(IDEAprojectdataadditionalinformationform).Ifyoufindat anypointduringyourinterviewingperiodthatyouchangethewayyouinterview(egatfirst you interview every patient but you then fall behind for a time and interview every 3rd patient) then please state any changes you make in your interviewing pattern. Please also explainthestepsyouhavetakentoensurethatyourselectionprocessisstillrandomasthisis importanttoensuretheresultsofthestudyareunbiased. 3. Tofurtherensurestudyresultsareunbiasedweaskthatyoucarryoutallinterviewsovera3 monthperiodfromthetimethatyoureceivethestudymaterials. CARRYINGOUTTHESTUDYDATARECORDINGANDINTERPRETATION 1. You will first need to complete Document 7 (Idea Project Data Part 1 Institution Information). This only needs to be completed once as it contains questions about the participatinginstitution. 2. Foreachpatientwhomyourecruittothestudyyouwillthenneedtoprint/photocopyand completeacopyofDocument8(IdeaProjectDataPart2PatientInterviewQuestionnaire Form).Theinterviewsaresemistructuredandtosummarisedatainthepatientsownwords / from their own experiences. For this reason we suggest the optimal way to collect and recorddataismakenotesdirectlyduringtheinterviewtocapturethekeypointsmadebythe patient.Weencourageyoutousedirectquotationstotryandcapturetheexperienceinthe patientsownwords. 3. The interviewer should also ask the patient to indicate an overall assessment for each questionontheVisualAnaloguescaleaddedtothequestion.Thepatientmustindicatetheir answer by placing a cross at the relevant part of the scale line which provides a readily comparable measureacross countries andcultures to help in theanalysis of overall patient experience. 4. Weaskthattheinterviewiscarriedoutinthelanguageofyourdiscretionbutweaskthatthe returns that you send to London be translated into English to enable comparative analysis betweencentres.Thismaymeanthatyouwriteinterviewnotesatthetimeinthepatients
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 5. PleasewatchtheDVDthataccompaniesthisdocumentwhichcontainsanexampleofagood interviewandshouldgiveyousomeideasongoodinterviewingtechnique.Pleasealsoshow thisDVDtoanyothercolleagueswhomaybeconductinginterviewsforyou. 6. A written example of how to conduct an interview question and fill out the proforma is providedbelow: Question1:Overalldoyoufeelthatyourstayinhospitalwasbeneficial? Howwellwasyourillnesstreated/doyoufeelbetter? Physicalneedsfood/shelter/hygieneIfpatientalsohadanotherillness(e.g.a cardiovasculardisorder):wereyougivengoodcareforyourotherillnesses Whichformoftherapydidyoufindparticularlyuseful(e.g.participationintherapygroups individualpsychotherapy,ECT,medications) Question1:Pleaserecordwritteninterviewnotes&quotationshere: Feels was treated well for the most part and now feels better. Does feel that physical needs were overlooked at times as has diabetes which did not always receive medication for on time / with meals. sometimes I thought they didnt care about my blood sugar Feels the accommodation was not ideal as had to share with another patient who was quite unwell and this was very upsetting for me Did not feel therapy groups were very useful as did not get much opportunity to speak though thinks that encouragement to take medications in healthcare setting helped get him on road to recovery. Interviewerdiscussesthisquestionwiththepatientinasemistructuredformatusingtheitalicised bulletpointsasaguideandrecordswrittennotesintheboxprovidedintheproforma. Interviewerthenaskspatienttoscorehis/heranswertoquestion1overallonthevisualanalogue scalebelow:

None

Excellent

7. AttheendofthestudypleasecompleteDocument9(IdeaProjectDataPart3Additional Information).Onthisblanksheetyoushouldletusknowanyinformationyouthinkisrelevant tothestudyyouhavecarriedoutlocallyincludinganyvariationsinsamplingprocedure,any difficulties you encountered with any aspect of the study that might bias or impact on the

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resultsandanyinformationabouthowyouthinkthestudyworkedwellandanycomments aboutwhatcouldhavebeenimproved. AFTERDATACOLLECTIONRETURNINGTHEDATAFORANALYSIS Attheendofthestudyyoushouldhavethefollowingdocumentation: 1. 2signedconsentformsfromtheheadofinstitutionagreeingtoallowyourinstitutiontotake partinthestudy 2. 1copyofthesignedconsentformfromtheheadoftheinstitution 3. Ethicsapprovalfromyoulocalethicscommitteetoproceed 4. 3x30signedconsentformsofthepatientsyourecruited(Document6) 5. 1completedcopyofDocument7:IDEAProjectDataPart1InstitutionInformation 6. 30completedcopiesofDocument8:IDEAProjectDataPart2PatientInterview QuestionnaireFormTranslatedintoENGLISH 7. 1completedcopyofDocument9:IDEAProjectDataPart3AdditionalInformation WenowneedtocoordinatethesafejourneyofthefollowingofthesedocumentstotheInstituteof Psychiatry,Londontoallowustocommencetheanalysis: 1. 1copyofthesignedconsentformfromtheheadoftheinstitution 2. 1x30copiesofthesignedconsentformsofthepatientsrecruitedtothestudy 3. 1completedcopyofDocument7:IDEAProjectDataPart1InstitutionInformation 4. 30completedcopiesofDocument8:IDEAProjectDataPart2PatientInterview QuestionnaireFormTranslatedintoENGLISH 5. 1completedcopyofDocument9:IDEAProjectDataPart3AdditionalInformation WeaskthatyoumakeaphotocopyofallstudydataandreturntheoriginalstoLondonbyCourier. Whenwecontactyoutoconfirmsafereceiptofyourdatapleasedestroythecopyofthestudydata youhavemade(fordataprotection/confidentialityreasons) YouwillfindcontactdetailsforreturningdatabycourierinDocument11(StudyCoordinator ContactDetails)

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DOCUMENT4 PATIENTINFORMATIONSHEET Ourstudy Weareconductingaresearchstudyonpatientsexperiencesofspendingtimeinpsychiatric hospitals,asyouhavejustdone.Wehopethatthefindingsofthestudywillimproveconditionsin suchhospitals.Theoriginalaspectofourstudyisthatwethinksuchimprovementscanbestbe madeifwetalktopatientsabouttheirexperiences,bothgoodandbad,andbaserecommendations forimprovementonwhatpatientstellus. Consideringwhethertotakepart Itisimportantthatyouunderstandwhatthestudyisaboutbeforeyoudecidetotakepart.Oneof ourteamwillgothroughthiswholeinformationsheetwithyoutomakesurethisisthecase.You canaskasmanyquestionsasyoulikeandpleasefeelfreetotalktootherpeopleaboutit. WhyamIbeinginvited? Youarebeinginvitedbecauseyouarejustabouttobedischargedfromyourinpatientstayandthis meansyouhaveexperienceofthehospitalwardatthistime.Weplantoinclude30peoplebeing dischargedfromthesamehospitalasyou. DoIhavetotakepart? Itisentirelyuptoyouwhetherornotyoutakepart.Ifyoudecidenotto,thiswillhavenoeffecton thecareyoureceive. WhatwillhappentomeifItakepart? Youwillbeinterviewedandaskedquestionsaboutyourexperiencesduringthishospitalstay.The interviewisintendedtogiveyoutheopportunitytotellus,inyourownwords,howyourstayhas beenandwhathavebeenthegoodandbadthingsaboutit.Theinterviewcoversthingslikewhether younowfeelbetter,thephysicalconditionsinthehospital,yourexperienceoftreatments,your satisfactionwiththestaff,yourconfidentialityandprivacy,whetheryoufeltsafeandwhetheryour rightswererespected.Theinterviewwilltakeabout20minutes. Willmytakingpartinthestudybekeptconfidential? Yes.Yournamewillnotberecordedontheinterviewformandnothingyousaycanbeassociated withyoupersonally.Yourinterviewerwillkeepwhatyoutellthemprivate.Youwillnotbe interviewedbysomeonewhohasbeencentrallyinvolvedintreatingyousoyoushouldbeableto speakopenlyaboutyourexperienceswhilstbeingassuredthatwhatyousaywillbekept confidential.Ifyoutellusanythingregardingthemisconductofamemberofstaffortheactionsof anotherpatientwewouldnotsharethisinformationwiththerelevantcomplaintsbodyunlessyou gavepermission.Anynamesorinformationthatcouldleadtotheidentificationofanotherperson (suchastheirphysicaldescription,age,ethnicityetc.)willnotberecorded.Thesuggestionsabout theservicesthatyoumakewillbemadeavailabletothechiefoftheserviceinaformatwhichwill notenableidentificationofyourself,sowillbeanonymous. WhatwillhappenifIwanttowithdrawfromthestudy?

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Youcanstoptheinterviewatanytimewithoutgivingareason.If,atalaterdate,youwantto withdrawyourwholeinterviewfromthestudyyoucandothattoo.Onceyourdatahasbeen collatedandanalysedasagroupitwillnolongerbepossibleforyoutowithdrawfromthestudyas yourdetailswillbecompletelyanonymised. Whatarethebenefitsoftakingpart? Therearenodirectbenefitstoyoupersonally.Butwehopetherewillbebenefitstootherpeoplein thefuturebecauseyourparticipationwillhelpformthebasisofrecommendationsforimprovements topsychiatrichospitals. Whatifthereisaproblem? Ifyoufeelbadlytreatedduringtheresearch,pleasefirstofalltellyourinterviewerwhowilltryto resolvethis.Ifyoudonotwanttodothis,oryourcomplaintcannotberesolved,pleasecontactone ofthestudycoordinators(seebelow). Whatwillhappentothestudyfindings? Thefindingswillbeusedtoevaluatepatientsexperiencesinpsychiatricinstitutionsinseveral countries.Theywillhelpensurethatpatientsviewsandsuggestionsbecomeknownandusedin ordertoimproveconditionsinpsychiatrichospitals.Lateron,wehopetoextendthestudytoother typesofmentalhealthservices. Whoisorganisingandfundingtheresearch? Yourdoctorwillnotbepaidforincludingyouinthisstudy.ItisbeingcarriedoutbyTheAssociation fortheImprovementofMentalHealthProgrammesandtheHealthServicesandPopulationResearch Department,InstituteofPsychiatry,KingsCollegeLondon,UK. Furtherinformationandcontactdetails EstelleMalcolm HealthServicesandPopulationResearchDepartment InstituteofPsychiatry,King'sCollegeLondon DeCrespignyPark,LondonSE58AF UnitedKingdom EmailAddress:estelle.1.malcolm@kcl.ac.uk

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DOCUMENT5 SCRIPTFORCONSENTINGPATIENTS Interviewersintroductoryscriptsuggestedscripttotranslateandreadtopatientwhenobtaining consenttorecruittotheIDEAproject: Hello,X,mynameisYandIampleasedtomeetyou.Ifyoudontmind,Iwouldliketotalktoyou about a research study that we are doing. Is that okay? We want to talk to patients about their experiences, good and bad, of being in psychiatric hospitals like this one. Our aim is to improve conditions in psychiatric hospitals for patients and we think the best way to do that is to find out frompatientsthemselveswhatitisliketospendtimeinhospitalslikethis.Wehaveputtogethera short interview which covers things like the physical conditions in institutions, your experiences of treatments like medication, ECT and talking treatments, your satisfaction with the staff, your confidentiality,privacyanddignity,howsafeyoufeltwhileinhospitalandwhetheryourrightswere respected.Theinterviewtakesabout20minutesanditiscompletelyconfidential.Wewantpatients tospeakopenlysoeverythingsaidwillbekeptprivate.Wearecarryingouttheinterviewsacouple ofdaysbeforepeoplearedischargedsothattheyhavethefullexperienceoftheirinpatientstay.I wouldliketointerviewyoufortheresearchstudyasyouareduetobedischargedsoon.Wouldyou agree to do this? If you are interested, I have some more information here. It is a written sheet whichgivesyouallthedetailsandwecangothroughittogetherandyoucanaskmeanyquestions you have about the study. Shall we do that now or would you prefer to have more time to think aboutitorareyouperhapsnotreallyinterested?
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DOCUMENT6: CONSENT FORM FOR PARTICIPANTS IN RESEARCH STUDIES

Please complete this form after you have read the Information Sheet and/or listened to an explanation about the research. Country: Institution Name: Title of Study: Inpatient Discharge: Experience & Analysis: An International Collaborative Study Kings College Research Ethics Committee Ref:________________ Institution Ethics Committee Ref: ________________ Thank you for considering taking part in this research. The person organising the research must explain the project to you before you agree to take part. If you have any questions arising from the Information Sheet or explanation already given to you, please ask the researcher before you decide whether to join in. You will be given a copy of this Consent Form to keep and refer to at any time. I understand that my participation is voluntary and that if I decide at any time during the research that I no longer wish to participate in this project, I can notify the researchers involved and withdraw from it immediately without giving any reason and without my medical care or legal rights being affected. Furthermore, I understand that I will be able to withdraw my data up to the point when the data will be analysed. I understand that relevant sections of my medical notes and data collected during the study, may be looked at by individuals from, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records.

Participants Statement: I _____________________________________________________________________ agree that the research project named above has been explained to me to my satisfaction and I agree to take part in the study. I have read both the notes written above and the Information Sheet about the project, and understand what the research study involves. Signed Name of Researcher Signature of Researcher taking consent When completed make 2 further photocopies of signed form: 1 for participant; 1 for researcher site file; 1 (original) to be kept in medical notes. Date Date

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DOCUMENT7 IDEAPROJECTDATAPART1 INSTITUTIONINFORMATION ONECOPYofthisdocumenttobecompletedtoprovidesomedetailedinformationaboutthetypeof psychiatricinstitutioninvolvedinthestudy.Thereisnoneedtocompletethisformforeverypatient includedinthestudy.

InstitutionDescriptionQuestions Name,address,country,telephonenumberof institution Interviewertocomplete

Nameandemailofthedirector

Typeofinstitution(i.e.hospital,socialcarehome, residential/longtermpsychiatricinstitution) Describethelocationoftheinstitution. Isitlocatedinaruralorurbansetting? Howaccessibleisitbypublictransport? Howfarisitfromthenearesttown? Aretheregates,orcanyou/visitors/residentswalk inandout(referheretolegallyvoluntaryresidents? Isthereaguard/visitorcheckinandcheckout system? Howistheinstitutionfinanced?(eg.what%bya ministry,localgovernment,residents,private individuals,localcommunity,church,etc Whatistheapproximateannualturnover/budgetof theinstitution(pleasestateclearlythefullnameof thecurrency) Howmanybeds/placesarethereintheinstitution? Approximate%ofmenandofwomen? Approximate%softhoseaged(i)under18;(2)18 65;(3)over65? Mostpeopleinthisunit/institutionareinwhichof thefollowingcategories:(1)peoplewithamental healthdiagnosis;(2)peoplewithanintellectual disabilitydiagnosis;(3)peoplewithasubstanceor alcoholabusediagnosis;(4)peoplewitha neurodegenerativediagnosis(e.g.Alzheimersor dementia)?

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 Aboutwhat%oftheresidentsaredeprivedor restrictedoflegalcapacity(underguardianship)? Whoaretheguardiansegfamilymembers, professionalstaff,thedirectoroftheinstitution) Whatistheaveragelengthofstayinthis unit/institution? Whatisthetotalnumberofstaffwhoworkinthis unit/institution?(fulltimeequivalentstaffnumbers) Howmanyofthestaffare: Psychiatrists Nonpsychiatricdoctors Qualifiednursingandalliedstaff Nonqualifiednurses Psychologists Howdoresidentsmakecomplaintsaboutanyaspect oftheinstitution? Doresidentsknowabouttheprocess? Aretheresidentsprovidedwiththenecessarymeans tocomplain(e.g.pens,paper,secureboxes)? Arerecordskeptaboutcomplaints? Isthereanannualreportpublishedandreviewed aboutcomplaints? Whatarethestepstakentodealwithunresolved complaintsandisthereanysystemofadvocacy? Arethefacilitiesgenerallyovercrowded(givedetails) Isthereadequateaccesstooutdoorareas Areallfacilitiesaccessibleforpeoplewithphysical andsensorydisabilities? Isthereanadequateprovisionofseparateareasfor menandwomen?

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 DOCUMENT8 IDEAPROJECTDATAPART2 PATIENTINTERVIEWQUESTIONNAIREFORM SECTION1:ANONYMISEDPATIENTINFORMATION(tobecompletedbytheinterviewer,pleasedo notwritethepatientsnameonthissheet) InterviewNumber(outof30) Interviewerinitialsandposition(psychiatrist/nurse/psychologistetc) PatientAge PatientSex Lengthofstayforcurrentadmission DateofDischarge DateofInterview PrimaryClinicalDiagnosis
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 Totalnumberofpsychiatrichospitalisations(inthisinstitutionorothersgivebestestimateof totalnumberofadmissions) Legalstatusforthisadmission(pleasecircle) Voluntaryinformal/Legallydetainedforatleastsomepartofadmission PatientLevelofEducation(pleasecircle) Noeducation/primaryschool/secondaryschool/college/university Marital/FamilialStatus(pleasecircle) Single/married/divorced/widowed Employmentstatus(pleasecircle) Student/employed/unemployed/retired

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SECTION2.SURVEYPROFORMA NotetoInterviewer:Whenaskingthequestionsinthisproformapleasetry andkeeptheinterviewformatinformalandsemistructuredandtalkaround the main questions and associated bullet points in black. However if specific pointers are needed thenthequestionsinitalicsmaybeusedtohelpaidtheflowoftheinterview.Theinterviewshould takenomorethan20minutesintotal.Pleaseonlyusethequestionsinitalicsasanaidetohelpthe flowofconversationasnecessary.Thequestionsdonotneedtobeaskedintheorderindicatedhere butpleasecoveralltheareassuggestedbythequestions.Pleaserecordverbatimquotationsfrom patientsasmuchaspossible. Please conduct the interview in a language of your discretion but please ensure this proforma is completedandreturnedinEnglishtoenablecomparativeanalysis. 1. Overalldoyoufeelyourstayinhospitalwasbeneficial? Howwellwasyourillnesstreated/doyoufeelbetter? Physicalneedsfood/shelter/hygieneIfpatientalsohadanotherillness(e.g.a cardiovasculardisorder):wereyougivengoodcareforyourotherillnesses Whichformoftherapydidyoufindparticularlyuseful(e.g.participationintherapygroups individualpsychotherapy,ECT,medications) Question1:Pleaserecordwritteninterviewnotes&quotationshere:

Question1:PleaseaskpatienttorecordoverallanswerforQ1onVisualAnalogueScale:Overalldoyou feelyourstayinhospitalwasbeneficial?

Not at all

Completely

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 2. Satisfactionwiththestaff Didyouknowwhichdoctorwasresponsibleforyourtreatment? Didyourpsychiatristseemtobeknowledgeable? Didyourpsychiatristseemtobeempathicand/orcommitted? Didyougetenoughsupportfromyourpsychiatrist? Wasyourpsychiatristrespectfultowardsyou? Didyouhaveenoughtimetospeakwithyoupsychiatristaboutyourdisorder?Whatabout nursingstaff?Didtheytreatyouwell?Doyoufeelthattheypaidenoughattentiontoyour requests?Ordidtheyspendtoomuchtimeonadministrativeissues?Doyoufeelthattheyare knowledgeable? Whataboutotherstaffthatyoumetpsychologists,socialworkers,nursingaids? Question2:Pleaserecordwritteninterviewnotes&quotationshere:

Question2:PleaseaskpatienttorecordoverallanswerforQ2onVisualAnalogueScaleHowsatisfied wereyouwiththestaff?

Not at all

Completely

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3.Doyoufeelthatyoucametoanyharmduringyourstayinhospital(throughotherpatientsand/or
membersofthestaff)?

Physicalsafety Emotionalharmdoyoufeelyouhademotionalsufferingasaresultofyourhospitalstay? Staffingadequatestaffinglevelstomeetyourneeds Doyoufeelthatyoucametoanyharmduringyourstayinhospital?

Question3:Pleaserecordwritteninterviewnotes&quotationshere:

Question3:PleaseaskpatienttorecordoverallanswerforQ3onVisualAnalogueScale:Doyoufeel thatyoucametoanyharmduringyourstayinhospital?

Experienced no harm

Experienced a great deal of harm

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 4. Wereyourindividualpreferencesandrightstakenintoaccount? Respectingofvalues/expressedneeds Frustration/Fairness/Handlingofaggressionontheward Clarityqualityofinformationgiventopatient Wereyouinformedbythestaffaboutyourrightsasapatient? Wasthelevelofinformationaboutyourrightsasapatientsatisfactory? Wastheexplanationofyourdiagnosisandtreatmentclearandunderstandable? Didyougetenoughinformationaboutbenefits/risksofthemedicationyouwere/areusing? Haveyoueverfeltstigmatisedbyanymemberofthestaffduringhospitalisation?Forexample didanymemberofstaffmakenegativecommentsaboutyourillness? Haveyoubeendiscriminatedagainstbecauseofyourmentalillness?Forexamplehaveyou everlostajobwhenyouremployerfoundoutyouhadamentalillness? Question4:Pleaserecordwritteninterviewnotes&quotationshere:

Question4:PleaseaskpatienttorecordoverallanswerforQ3onVisualAnalogueScale:Wereyour individualrightsandpreferencestakenintoaccount?

Not at all

Completely

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 5. Wasyourrighttoconfidentialityobserved? Dignityandprivacy Involvementoffamilyandfriends Doyouconsiderthatthestaffrespectedyourconfidentiality?Didtheydiscussyourcasewith inappropriatepeople(egotherpatients/familymemberswithoutyourpermission) Wasyourfamilyadequatelyinformedandengagedinthetreatmentprocess? Didyouobtainanaccesstothetelephoneorotherfacilitiesenablingcontactwithyourfamily and/orfriends?

Question5:Pleaserecordwritteninterviewnotes&quotationshere:

Question5:PleaseaskpatienttorecordoverallanswerforQ3onVisualAnalogueScale:Wasyourright toconfidentialityobserved?

Not at all

Completely

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 6. Whatarethemainimprovementsthatshouldbemadetothisservice? Ifyoucould,wouldyouchangesomethinginthisservice?Whatwouldyouchange? Doyouhaveanycomments,suggestionsorsomethingtoaddforthetreatmentinthis hospital/ward? Wouldyourecommendthishospital/wardfortreatmenttosomeoneelsewhoneededit? Wouldyouvisitthesamehospital/wardagainifyouneededhelp? Question6:Pleaserecordwritteninterviewnotes&quotationshere:

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DOCUMENT9 IDEAPROJECTDATAPART3 ADDITIONALINFORMATION Pleaseusethissheettorecordanyadditionalinformationthatyoufeelwouldbeofusetothe analysisofthestudydata.Thiscouldincludevariationsinsamplingprocedure,concernsabout difficultiesindatacollectionorrecording,commentsaboutwhatwentwellduringthestudyand whatcouldbedonebetterinfuturestudies.YouonlyneedtoreturnONEcopyofthisdocumentwith thestudydata.Pleasecontinueontoaseparatesheetifnecessary.

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 DOCUMENT10 QUICKREFERENCEGUIDE:IDEAPROJECTCHECKLISTFORRESEARCHERS

o ReadIDEAProjectProtocol&watchaccompanyingDVD o ApproachHeadofInstitutionforpermissiontocarryoutstudy(usingexecutivesummary
inDocument2)

o Obtain2xsignedconsentformsfromHeadofInstitution(Document2&Document3) o Obtainlocalethicscommitteeapprovaltocarryoutstudy o Workoutstrategyforrecruitmentof30patientstostudyusingdetailedguidancein

Document6

o Ensurepatientinformationsheetandscript(Documents4&5)havebeentranslatedinto
local/patientlanguage

o Commencestudybycarryingout30interviewswithpatientswithin2daysofdischarge.
Ensureaconsentformissignedbyeachpatientandthatyoumake2furtherphotocopies oftheoriginal

o Allinterviewstobecompletedovera3monthperiod o EnsureallinterviewstranslatedintoEnglishandallinterviewproformasarecompletedin
EnglishinpreparationforreturningtoLondon

o Arrangeforreturnof
1PHOTOCOPYofheadofserviceconsentform(Document2) 1ORIGINALof30patientconsentforms(Document6) 1completedDocument7(Part1InstitutionInformation) 30completedDocument8(Part2PatientInterviewQuestionnaireForm) 1completedDocument9(Part3AdditionalInformation) ToInstituteofPsychiatry,KingsCollegeLondonforcommencementofanalysis(see Document11forfurtherinformationonhowtoreturndata) Anyquestionsatanytime?PleasecontactstudycoordinatorEstelleMalcolm,Instituteof Psychiatry,KingsCollegeLondon EmailAddress:estelle.1.malcolm@kcl.ac.uk TelephoneNumber:+44(0)2078480612 Fax:+44(0)2072771462

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DOCUMENT11 HOWTORETURNDATA&STUDYCOORDINATORCONTACTDETAILS Pleasereturnalldatabycouriertothestudycoordinator. Ms.EstelleMalcolm HealthServicesandPopulationResearchDepartment InstituteofPsychiatry,King'sCollegeLondon DeCrespignyPark,LondonSE58AF UnitedKingdom EmailAddress:estelle.1.malcolm@kcl.ac.uk TelephoneNumber:+44(0)2078480612 Fax:+44(0)2072771462 Ifthereisfundingavailablefromyourinstitutionforthisreturnweaskthatyouusethissourceto paytocourierthestudydatasafely.IfthisisnotpossiblepleasecontactEstelleMalcolm,study coordinator,whowillbeabletoassistwithfundingcourierreturns. PLEASECONTACTMs.EstelleMalcolm,THESTUDYCOORDINATOR,FORALLQUERIESREGARDING ANYASPECTOFTHESTUDY.GOODLUCK!

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