1. Effectiveness of health checks to improve the physical health of patients with severe mental illness: a single blind cluster randomised controlled trial of the health improvement profile (HIP) Jacqueline White [1] Joanne Lucas [2], Louise Swift [3,4], Garry R Barton [3,4], Harriet Gough [5], Lisa Irvine [3,4], Gabriel Abotsie [5], Martin Jones [6], Richard Gray [7] 1.Faculty of Health and Social Care, University of Hull 2.Nursing Sciences, University of East Anglia 3.Norwich Medical School, University of East Anglia 4.Norwich Clinical Trials Unit, University of East Anglia 5.Norfolk and Suffolk NHS Foundation Trust 6.University of South Australia 7.Hamad Medical Corporation, Doha, Qatar

2. Background Reduced Life Expectancy Mortality is due to cardiovascular disease (CVD) Health checks are assessments intended to screen patients for comorbidity (e.g. CVD risk)

3. Background Practice guidelines recommend annual health checks for people with SMI Health checks occur less frequently in SMI and to be of inferior quality Mental health nurses motivated to improve the physical health of patients with SMI Extended Role

4. The Health Improvement Profile (HIP)

5. Method A single blind cluster randomised controlled trial – Treatment as usual plus the HIP (health check) – Treatment as usual

6. Inclusion/exclusion criteria Nurses – Registered nurse for a minimum of six months – Were working clinically in an adult community setting – At least five SMI patients on their caseload Patients – Over 18 years of age, – With mental capacity (determined by an appropriately trained clinician) – Confirmed primary diagnosis of schizophrenia, schizoaffective or bipolar disorder – Additional exclusion criteria Serious or unstable medical condition Were pregnant or six months post partum A senior clinician determined that patient participation in the trial would put the patient, treating clinical or research team at increased risk

7. Recruitment of nurses Researchers presented the project to generic and specialist adult community mental health teams (recovery, rehabilitation, assertive outreach and forensic teams) CMHNs who expressed an interest were followed up and consent obtained

8. Recruitment of patients Nurses screened their own caseload Selected patients invited by their nurse to participate Patients understanding of the study and obtained written informed consent The cycle was repeated until five patients had been recruited

9. Randomisation and blinding Nurse randomised to receive either the HIP Programme or treatment as usual (TAU) Permuted blocks of random size Trial Coordinators were informed by email of the group allocation Research assistants blind to group allocation u

10. Intervention Patients in both group received TAU In addition, nurses in the intervention group received training, and were asked to implement an annual health check using the HIP with patient participants on their caseload

11. Outcome measures The primary outcome was the physical wellbeing of patients at 12 months follow-up – Measured using the physical component subscale [PCS] of the Medical Outcome Study (MOS) 36 item Short Form Health Survey version 2 (SF-36v2) The SF36v2 and PCS have demonstrated sensitivity to change in SMI outpatient populations

12. Data collection Outcome measures completed at group allocation at baseline and 12-month follow up Researchers were trained to administer the outcome measures to patients using procedures described in the SF-36v2 user guide

14. Fewer than half the health checks were completed by CMHNs

15. A quarter of the health checks were completed by CMHNs

16. Characteristics of CMHNs at baseline (Intention to Treat Analysis)

22. Adverse event reporting

23. Conclusion Health checks delivered by nurses not effective at improving the physical wellbeing of SMI patients First trial of the effectiveness of health checks in an SMI population. Challenge guideline recommendations

24. Effectiveness of health checks to improve the physical health of patients with severe mental illness: a single blind cluster randomised controlled trial of the health improvement profile (HIP) Jacqueline White [1] Joanne Lucas [2], Louise Swift [3,4], Garry R Barton [3,4], Harriet Gough [5], Lisa Irvine [3,4], Gabriel Abotsie [5], Martin Jones [6], Richard Gray [7] 1.Faculty of Health and Social Care, University of Hull 2.Nursing Sciences, University of East Anglia 3.Norwich Medical School, University of East Anglia 4.Norwich Clinical Trials Unit, University of East Anglia 5.Norfolk and Suffolk NHS Foundation Trust 6.University of South Australia 7.Hamad Medical Corporation, Doha, Qatar