1. PROMs Pilot for Long-Term Conditions in Primary Care Ray Fitzpatrick Department of Public Health

2. Research team Ray Fitzpatrick - Chief Investigator Michele Peters - Project Manager Crispin Jenkinson – Principal Investigator Alastair Gray – Health Economist Helen Doll- Statistician Helen Boyce – Data Manager Helen Boyce – Data Manager Elizabeth Gibbons - Interviewer Elizabeth Gibbons - InterviewerFunding Department of Health, Policy Research Programme

3. Rationale

4. Patient-reported Outcome Measures (PROMs) Developed in the last 30 years to involve patients directly in judgements of health status and outcomes of services Developed in the last 30 years to involve patients directly in judgements of health status and outcomes of services Variously termed measures of: Variously termed measures of: Health status, health-related quality of life, functional status, patient-reported outcome or outcome Health status, health-related quality of life, functional status, patient-reported outcome or outcome Usually short self-report questionnaires Usually short self-report questionnaires Generic (EQ-5D and SF-36) or disease-specific (QOLIE-89 for epilepsy) Generic (EQ-5D and SF-36) or disease-specific (QOLIE-89 for epilepsy)

5. The use of PROMs Used in research or audit Used in research or audit Outcome measure in clinical trials Outcome measure in clinical trials Health services research Health services research Population survey Population survey Individual patient care Individual patient care Outcome measure for health services Outcome measure for health services From 2009, PROMs mandated for 4 elective surgical procedures (primary hip replacement, primary knee replacement, groin hernia repair and varicose vein procedures) From 2009, PROMs mandated for 4 elective surgical procedures (primary hip replacement, primary knee replacement, groin hernia repair and varicose vein procedures) Used separately or jointly (generic and disease-specific in combination) Used separately or jointly (generic and disease-specific in combination)

6. Why collect PROMs data? If quality is to be at the heart of everything we do, it must be understood from the perspective of patients. Patients pay regard both to clinical outcomes and their experience of the service... If quality is to be at the heart of everything we do, it must be understood from the perspective of patients. Patients pay regard both to clinical outcomes and their experience of the service... Quality of care should include effectiveness of care. This means understanding success rates from different treatments from different treatments for different conditions. Assessing this will include clinical measures such as mortality or survival rates, complication rates……. Just as important is the effectiveness of care from the patient’s own perspective which will be measured through patient-reported outcome measures (PROMs)… Quality of care should include effectiveness of care. This means understanding success rates from different treatments from different treatments for different conditions. Assessing this will include clinical measures such as mortality or survival rates, complication rates……. Just as important is the effectiveness of care from the patient’s own perspective which will be measured through patient-reported outcome measures (PROMs)… High Quality Care for All: NHS Next Stage Review Final Report.

7. Why collect PROMs data? NHS Outcomes Framework domains NHS Outcomes Framework domains Effectiveness of treatment and care provided – measured by clinical outcomes and patient-reported outcomes Effectiveness of treatment and care provided – measured by clinical outcomes and patient-reported outcomes Safety of treatment and care provided Safety of treatment and care provided Broader experience patients have of the treatment and care they receive Broader experience patients have of the treatment and care they receive Department of Health. Equity and Excellence: Liberating the NHS. 2010

8. Aims and objectives To evaluate the feasibility and acceptability of using PROMs for long-term conditions (LTCs) in primary care To evaluate the feasibility and acceptability of using PROMs for long-term conditions (LTCs) in primary care To assess possible barriers to individuals with LTCs completing PROMs To assess possible barriers to individuals with LTCs completing PROMs To assess cost of collecting PROMs data To assess cost of collecting PROMs data LTCs LTCs asthma, COPD, diabetes, epilepsy, heart failure and stroke asthma, COPD, diabetes, epilepsy, heart failure and stroke

9. PROMs Pilot Study Design

10. Design Multi-method design (postal survey and qualitative interviews) Multi-method design (postal survey and qualitative interviews) Two surveys Two surveys Cohort (one year apart) Cohort (one year apart) Cross-sectional Cross-sectional Interviews with individuals with a LTC and professional stakeholders (managers, PCT senior staff, GPs) Interviews with individuals with a LTC and professional stakeholders (managers, PCT senior staff, GPs)

11. PROMs Pilot GP DATABASE COHORT BASELINE COHORT FOLLOW-UPCROSS-SECTIONAL MAIL SURVEY 50% RECRUIT PRACTICES 12 months 0 months

12. PROMs pilot practice recruitment Sample Sample 18 years or over 18 years or over Approximately 4500 (750 per condition) Approximately 4500 (750 per condition) Location Location London and North-West England(NWE) London and North-West England(NWE) Based on QOF prevalence, need approximately 40 practices, half in London and half in NWE Based on QOF prevalence, need approximately 40 practices, half in London and half in NWE Recruited through Primary Care Trusts (PCTs) and PCRN (Primary Care Research Network) Recruited through Primary Care Trusts (PCTs) and PCRN (Primary Care Research Network)

13. What do practices need to do? Consent to automatic database search to identify patients Practice staff check of patient list Print address labels Attach labels to pre-packed questionnaires and reminders Mail questionnaires After 2 weeks, mail reminders

14. PROMs pilot database search Automatic and remote search of GP QOF databases by Apollo Medical Systems Ltd. Automatic and remote search of GP QOF databases by Apollo Medical Systems Ltd. Apollo developed software for Apollo developed software for GP patient survey by the Department of Health GP patient survey by the Department of Health No information on patients will be available to Apollo or the research team No information on patients will be available to Apollo or the research team Search run over night to not disrupt practices day to day work Search run over night to not disrupt practices day to day work

15. PROMs pilot qualitative interviews Individuals with a LTC Individuals with a LTC 55 interviews 55 interviews Both with responders (incomplete data) and non-responders to the survey Both with responders (incomplete data) and non-responders to the survey Aim to identify barriers for completing PROMs Aim to identify barriers for completing PROMs Professional stakeholders Professional stakeholders 30 interviews 30 interviews Managers, PCT senior staff, GPs Managers, PCT senior staff, GPs Aim to identify value of using PROMs and any problems with administering PROMs Aim to identify value of using PROMs and any problems with administering PROMs

16. Analysis Survey Survey Response rates and quality of information between the two surveys (cohort vs. cross-sectional), over time (cohort) and for the 6 LTCs Response rates and quality of information between the two surveys (cohort vs. cross-sectional), over time (cohort) and for the 6 LTCs Qualitative interviews Qualitative interviews Thematic analysis to identify barriers to completing PROMs (individuals with LTC) Thematic analysis to identify barriers to completing PROMs (individuals with LTC) Thematic analysis to identify value of using PROMs and barriers to PROMs (professional stakeholders) Thematic analysis to identify value of using PROMs and barriers to PROMs (professional stakeholders)

17. Results and outputs Report to the Department of Health Report to the Department of Health Presentations of findings to stakeholders Presentations of findings to stakeholders Opportunity for stakeholders to comment on the pilot methodology and findings Opportunity for stakeholders to comment on the pilot methodology and findings Summary of findings to all participating practices Summary of findings to all participating practices Summary of findings on web-page for participants and professional stakeholders Summary of findings on web-page for participants and professional stakeholders http://www.publichealth.ox.ac.uk/research/hsru/asking- you-about-your-health http://www.publichealth.ox.ac.uk/research/hsru/asking- you-about-your-health

18. Results and outcomes Results (response rates, completeness of data, estimation of cost) will inform DH decisions whether PROMs are an acceptable way of involving the public and measuring health outcomes of the NHS on a large, national scale Results (response rates, completeness of data, estimation of cost) will inform DH decisions whether PROMs are an acceptable way of involving the public and measuring health outcomes of the NHS on a large, national scale Results will enable DH to decide whether PROMs can be more generally rolled out to engage the public in the assessment of quality of health care services for LTCs Results will enable DH to decide whether PROMs can be more generally rolled out to engage the public in the assessment of quality of health care services for LTCs

19. Progress to date

20. Ethics Approval Ethics Approval NHS permissions NHS permissions NIHR portfolio adoption NIHR portfolio adoption Service support costs for practices Service support costs for practices Selecting and licensing PROMs Selecting and licensing PROMs Apollo search Apollo search Recruitment of practices Recruitment of practices Pilot Pilot

21. Ethics and NHS permissions Ethical approval obtained from National Research Ethics Committee Ethical approval obtained from National Research Ethics Committee Majority of NHS permissions obtained for the participating PCTs Majority of NHS permissions obtained for the participating PCTs Adopted onto NIHR (National Institute of Health Research) portfolio Adopted onto NIHR (National Institute of Health Research) portfolio http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=846 2 http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=846 2 Application for service support costs for practices through CLRN in progress Application for service support costs for practices through CLRN in progress

22. Which PROMs? Selected on basis of reviews by Oxford PROMs group and IP (Intellectual Property) review by the Department of Health Selected on basis of reviews by Oxford PROMs group and IP (Intellectual Property) review by the Department of Health Questionnaires Questionnaires One generic PROM – EQ-5D One generic PROM – EQ-5D One disease-specific PROM One disease-specific PROM Some additional socio-demographic and co- morbidity questions Some additional socio-demographic and co- morbidity questions

23. Disease-specific PROMs Asthma - Mini Asthma Quality of Life Questionnaire Asthma - Mini Asthma Quality of Life Questionnaire COPD - Clinical COPD Questionnaire COPD - Clinical COPD Questionnaire Diabetes – Diabetes Health Profile Diabetes – Diabetes Health Profile Epilepsy – Quality of Life in Epilepsy Epilepsy – Quality of Life in Epilepsy Heart Failure – Minnesota Living with Heart Failure Questionnaire Heart Failure – Minnesota Living with Heart Failure Questionnaire Stroke – Stroke Impact Scale Stroke – Stroke Impact Scale

24. Identification of patients Search Search Based on same Read Codes as QOF, including medication codes for asthma and epilepsy Based on same Read Codes as QOF, including medication codes for asthma and epilepsy Stroke does not include TIAs Stroke does not include TIAs Patients with ‘refused consent’ code are excluded Patients with ‘refused consent’ code are excluded Patients only included for one LTC Patients only included for one LTC Search developed for 3 clinical systems Search developed for 3 clinical systems Search produces patient list on practices computer from which address labels can be printed Search produces patient list on practices computer from which address labels can be printed

25. Recruitment of practices Through PCTs, PCRN and DRN (London) Through PCTs, PCRN and DRN (London) Expression of interest Expression of interest Return of ‘Practice Information Form’ Return of ‘Practice Information Form’ Practice contact details Practice contact details Information on clinical systems Information on clinical systems LTCs the practice wishes to cover LTCs the practice wishes to cover 12 London practices and 15 NWE 12 London practices and 15 NWE ‘Pilot’ sites ‘Pilot’ sites

26. Key milestones Cohort baseline survey Cohort baseline survey Analysis of cohort baseline data Analysis of cohort baseline data Qualitative interviews with patients Qualitative interviews with patients Qualitative interviews with professionals Qualitative interviews with professionals Cross-sectional survey Cross-sectional survey Cohort follow up survey Cohort follow up survey Analysis of cross-sectional survey and cohort follow-up Analysis of cross-sectional survey and cohort follow-up Feedback of results to stakeholders Feedback of results to stakeholders