Managing cardiovascular risk for people with severe mental illnesses. A clinical trial in primary care. (PRIMROSE)

Conditions

Cardiovascular risk for people with severe mental illnesses Circulatory System Cardiovascular disease, unspecified

David Osborn, Alexandra Burton, Kate Walters, Lou Atkins, Thomas R. E. Barnes et al. (27 authors)

Programme Grants for Applied Research2019-04-0115 citations

Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: a cluster randomised controlled trial.

Osborn D, Burton A, Hunter R, Marston L, Atkins L, Barnes T, Blackburn R, Craig T, Gilbert H, Heinkel S, Holt R, King M, Michie S, Morris R, Morris S, Nazareth I, Omar R, Petersen I, Peveler R, Pinfold V, Walters K.

2018-01-2261 citations

10.1016/s2215-0366(18)30007-5

Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial.

Osborn D, Burton A, Walters K, Nazareth I, Heinkel S, Atkins L, Blackburn R, Holt R, Hunter R, King M, Marston L, Michie S, Morris R, Morris S, Omar R, Peveler R, Pinfold V, Zomer E, Barnes T, Craig T, Gilbert H, Grey B, Johnston C, Leibowitz J, Petersen I, Stevenson F, Hardy S, Robinson V.

2016-02-1214 citations

10.1186/s13063-016-1176-9

Interventions

Standard care Primrose intervention, Practice led intensive CVD risk management service including: 1. Brief behavioural advice and support on diet, exercise and smoking 2. Referral to support service

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 01/09/2015: 1. GP patients with a computer diagnosis of severe mental illness (SMI), i.e. Schizophrenia, Persistent Delusional disorder, Schizoaffective disorder, Bipolar affective disorder 2. Raised total cholesterol of 5 mmol/l or more or total cholesterol/HDL ratio of 4 mmol/l or more AND one or more of the following risk factors: 2.1. BMI > 30 kg/m2 2.2. Current smoker 2.3. Blood pressure >140mm Hg systolic AND/OR >90 mm Hg diastolic on two or more consecutive occasions 2.4. HbA1c of 42- 47 mmol/mol (6.0-6.4%) 2.5 Diagnosis of hypertension 2.6 Diagnosis of diabetes 3. Male & Female; Upper Age Limit 75 years ; Lower Age Limit 30 years 4. Able to give written informed consent Previous inclusion criteria from 30/05/2013 to 01/09/2015: 1. GP patients with a computer diagnosis of severe mental illness (SMI), i.e. Schizophrenia (ICD-10, F20), Persistent Delusional disorder (ICD-10, F22), Schizoaffective disorder (ICD-10, F25), Bipolar affective disorder (ICD-10, F31) 2. Raised total cholesterol over 5 mmol/l or total cholesterol/HDL ratio above 4 mmol/lAND one or more of the following risk factors: 2.1. BMI > 30 kg/m2 2.2. Current smoker 2.3. Blood pressure >140mm Hg systolic AND/OR >90 mm Hg diastolic on two or more consecutive occasions 2.4. HbA1c of 42- 47 mmol/mol (6.0-6.4%) 3. Male & Female; Upper Age Limit 75 years ; Lower Age Limit 30 years 4. Able to give written informed consent Original inclusion criteria: 1. GP patients with a computer diagnosis of severe mental illness (SMI), i.e. Schizophrenia (ICD-10, F20), Persistent Delusional disorder (ICD-10, F22), Schizoaffective disorder (ICD-10, F25), Bipolar affective disorder (ICD-10, F31) 2. Raised total cholesterol over 5mmol/l or CVD 10 year risk score above 10% 3. Male & Female; Upper Age Limit 85 years ; Lower Age Limit 30 years 4. Able to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Too acutely unwell defined as under acute psychiatric care 2. Primary diagnosis of an organic mental health problem and/or severe cognitive impairment 3. Life expectancy < 6 months 4. Pre-existing CVD Added 01/09/2015: 5. Currently pregnant

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 01/09/2015: Total Cholesterol; Timepoint(s): Baseline, 6 and 12 months Previous primary outcome measures from 30/05/2013 to 01/09/2015: Total Cholesterol; Timepoint(s): Baseline, 3, 6 and 12 months Original primary outcome measures: CVD risk score; Timepoint(s): Baseline, 6 and 12 months	—

Secondary

Measure	Time frame
Current primary outcome measures as of 01/09/2015: 1. 10 year CVD risk scores 2. Changes in cardiovascular risk factors, including HBA1c, waist circumference, HDL cholesterol, BMI, blood pressure, total/HDL cholesterol ratio and smoking reduction and abstinence 3. Changes in exercise and diet 4. Changes in alcohol use 5. Adherence to the intervention, including attendance at services and appointments 6. Proportions accepting and continuing CVD risk reducing medications and interventions (e.g. statins, nicotine replacement therapy, bupropion) 7. Satisfaction with primary care services 8. All hospital admissions and health service use during the trial period. 9. Quality of life 10. Incremental costs of the intervention, from the perspective of the NHS and PSS 11. Cost-effectiveness of the intervention, measured in terms of the primary and secondary outcome measures, plus quality-adjusted life years (QALYs), estimated at one year and lifetime. 12. Psychiatric outcomes and wellbeing Previous primary outcome measures from 30/05/2013 to 01/09/2015: 1. 10 year CVD risk scores 2. Changes in a multivariate outcome comprising of BMI, blood pressure and total cholesterol/HDL cholesterol ratio 3. Changes in cardiovascular risk factors, including HBA1c fasting glucose, waist circumference, HDL cholesterol, smoking reduction and abstinence 4. Changes in exercise and diet 5. Changes in alcohol use 6. Adherence to the intervention, including attendance at services and appointments 7. Proportions accepting and continuing CVD risk reducing medications and interventions (e.g. statins, nicotine replacement therapy, bupropion) 8. Satisfaction with the intervention 9. All hospital admissions during the trial period. 10. Quality of life 11. Incremental costs of the intervention, from the perspective of the NHS and PSS 12. Cost-effectiveness of the intervention, measured in terms of the primary and secondary outcome measures, plus quality-adjusted life years (QALYs), estimated at one ye	—

Measure

Time frame

Current primary outcome measures as of 01/09/2015: 1. 10 year CVD risk scores 2. Changes in cardiovascular risk factors, including HBA1c, waist circumference, HDL cholesterol, BMI, blood pressure, total/HDL cholesterol ratio and smoking reduction and abstinence 3. Changes in exercise and diet 4. Changes in alcohol use 5. Adherence to the intervention, including attendance at services and appointments 6. Proportions accepting and continuing CVD risk reducing medications and interventions (e.g. statins, nicotine replacement therapy, bupropion) 7. Satisfaction with primary care services 8. All hospital admissions and health service use during the trial period. 9. Quality of life 10. Incremental costs of the intervention, from the perspective of the NHS and PSS 11. Cost-effectiveness of the intervention, measured in terms of the primary and secondary outcome measures, plus quality-adjusted life years (QALYs), estimated at one year and lifetime. 12. Psychiatric outcomes and wellbeing Previous primary outcome measures from 30/05/2013 to 01/09/2015: 1. 10 year CVD risk scores 2. Changes in a multivariate outcome comprising of BMI, blood pressure and total cholesterol/HDL cholesterol ratio 3. Changes in cardiovascular risk factors, including HBA1c fasting glucose, waist circumference, HDL cholesterol, smoking reduction and abstinence 4. Changes in exercise and diet 5. Changes in alcohol use 6. Adherence to the intervention, including attendance at services and appointments 7. Proportions accepting and continuing CVD risk reducing medications and interventions (e.g. statins, nicotine replacement therapy, bupropion) 8. Satisfaction with the intervention 9. All hospital admissions during the trial period. 10. Quality of life 11. Incremental costs of the intervention, from the perspective of the NHS and PSS 12. Cost-effectiveness of the intervention, measured in terms of the primary and secondary outcome measures, plus quality-adjusted life years (QALYs), estimated at one ye

—

Countries

United Kingdom

Outcome results

None listed