Randomized Controlled Trial

. 2016 Feb 12:17:80.

doi: 10.1186/s13063-016-1176-9.

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

David Osborn^{1

2}, Alexandra Burton³, Kate Walters⁴, Irwin Nazareth⁵, Samira Heinkel⁶, Lou Atkins⁷, Ruth Blackburn⁸, Richard Holt⁹, Racheal Hunter¹⁰, Michael King¹¹, Louise Marston¹², Susan Michie¹³, Richard Morris¹⁴, Steve Morris¹⁵, Rumana Omar¹⁶, Robert Peveler¹⁷, Vanessa Pinfold¹⁸, Ella Zomer¹⁹, Thomas Barnes²⁰, Tom Craig²¹, Hazel Gilbert²², Ben Grey²³, Claire Johnston²⁴, Judy Leibowitz²⁵, Irene Petersen²⁶, Fiona Stevenson²⁷, Sheila Hardy²⁸, Vanessa Robinson²⁹

Affiliations

¹ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. d.osborn@ucl.ac.uk.
² Camden and Islington NHS Foundation Trust, 4th Floor, East Wing, St Pancras Hospital, 4 St Pancras Way, London, NW1 0PE, UK. d.osborn@ucl.ac.uk.
³ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.
⁴ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. k.walters@ucl.ac.uk.
⁵ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. i.nazareth@ucl.ac.uk.
⁶ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.heinkel@ucl.ac.uk.
⁷ Division of Psychology and Language Sciences, Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, Faculty of Brain Sciences, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. l.atkins@ucl.ac.uk.
⁸ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. r.blackburn.12@ucl.ac.uk.
⁹ Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.I.G.Holt@soton.ac.uk.
¹⁰ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. r.hunter@ucl.ac.uk.
¹¹ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. michael.king@ucl.ac.uk.
¹² Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. l.marston@ucl.ac.uk.
¹³ Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. s.michie@ucl.ac.uk.
¹⁴ UCL Department of Applied Health Research, Institute of Epidemiology and Health Care, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. richard.morris@bristol.ac.uk.
¹⁵ School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. steve.morris@ucl.ac.uk.
¹⁶ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. r.omar@ucl.ac.uk.
¹⁷ Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.C.Peveler@soton.ac.uk.
¹⁸ The McPin Foundation, 32-36 Loman Street, London, SE1 0EH, UK. VanessaPinfold@mcpin.org.
¹⁹ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. e.zomer@ucl.ac.uk.
²⁰ Department of Medicine, Faculty of Medicine, Imperial College London, Commonwealth Building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK. t.r.barnes@imperial.ac.uk.
²¹ Institute of Psychiatry, Psychology & Neuroscience, Kings College London, 16 De Crespigny Park, London, SE5 8AF, UK. thomas.craig@kcl.ac.uk.
²² Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. hazel.gilbert@ucl.ac.uk.
²³ School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. bengray@mcpin.org.
²⁴ Camden and Islington NHS Foundation Trust, 4th Floor, East Wing, St Pancras Hospital, 4 St Pancras Way, London, NW1 0PE, UK. claire.johnston@candi.nhs.uk.
²⁵ Camden and Islington NHS Foundation Trust, 4th Floor, East Wing, St Pancras Hospital, 4 St Pancras Way, London, NW1 0PE, UK. judy.leibowitz@candi.nhs.uk.
²⁶ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. i.petersen@ucl.ac.uk.
²⁷ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. f.stevenson@ucl.ac.uk.
²⁸ University of Northampton, Berrywood Hospital, Berrywood Drive, Upton, Northampton, NN5 6UD, UK. Sheila.Hardy@nhft.nhs.uk.
²⁹ Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK. vanessarobinson331@yahoo.co.uk.

PMID: 26868949
PMCID: PMC4751703
DOI: 10.1186/s13063-016-1176-9

Randomized Controlled Trial

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

David Osborn et al. Trials. 2016.

. 2016 Feb 12:17:80.

doi: 10.1186/s13063-016-1176-9.

Authors

Affiliations

¹ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. d.osborn@ucl.ac.uk.
² Camden and Islington NHS Foundation Trust, 4th Floor, East Wing, St Pancras Hospital, 4 St Pancras Way, London, NW1 0PE, UK. d.osborn@ucl.ac.uk.
³ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.
⁴ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. k.walters@ucl.ac.uk.
⁵ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. i.nazareth@ucl.ac.uk.
⁶ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.heinkel@ucl.ac.uk.
⁷ Division of Psychology and Language Sciences, Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, Faculty of Brain Sciences, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. l.atkins@ucl.ac.uk.
⁸ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. r.blackburn.12@ucl.ac.uk.
⁹ Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.I.G.Holt@soton.ac.uk.
¹⁰ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. r.hunter@ucl.ac.uk.
¹¹ Division of Psychiatry, Epidemiology and Applied Clinical Research Department, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. michael.king@ucl.ac.uk.
¹² Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. l.marston@ucl.ac.uk.
¹³ Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. s.michie@ucl.ac.uk.
¹⁴ UCL Department of Applied Health Research, Institute of Epidemiology and Health Care, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. richard.morris@bristol.ac.uk.
¹⁵ School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. steve.morris@ucl.ac.uk.
¹⁶ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. r.omar@ucl.ac.uk.
¹⁷ Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.C.Peveler@soton.ac.uk.
¹⁸ The McPin Foundation, 32-36 Loman Street, London, SE1 0EH, UK. VanessaPinfold@mcpin.org.
¹⁹ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. e.zomer@ucl.ac.uk.
²⁰ Department of Medicine, Faculty of Medicine, Imperial College London, Commonwealth Building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK. t.r.barnes@imperial.ac.uk.
²¹ Institute of Psychiatry, Psychology & Neuroscience, Kings College London, 16 De Crespigny Park, London, SE5 8AF, UK. thomas.craig@kcl.ac.uk.
²² Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. hazel.gilbert@ucl.ac.uk.
²³ School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. bengray@mcpin.org.
²⁴ Camden and Islington NHS Foundation Trust, 4th Floor, East Wing, St Pancras Hospital, 4 St Pancras Way, London, NW1 0PE, UK. claire.johnston@candi.nhs.uk.
²⁵ Camden and Islington NHS Foundation Trust, 4th Floor, East Wing, St Pancras Hospital, 4 St Pancras Way, London, NW1 0PE, UK. judy.leibowitz@candi.nhs.uk.
²⁶ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. i.petersen@ucl.ac.uk.
²⁷ Department of Primary Care and Population Health, Institute of Epidemiology and Health Care, University College London, Rowland Hill St, London, NW3 2PF, UK. f.stevenson@ucl.ac.uk.
²⁸ University of Northampton, Berrywood Hospital, Berrywood Drive, Upton, Northampton, NN5 6UD, UK. Sheila.Hardy@nhft.nhs.uk.
²⁹ Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK. vanessarobinson331@yahoo.co.uk.

PMID: 26868949
PMCID: PMC4751703
DOI: 10.1186/s13063-016-1176-9

Abstract

Background: People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices.

Methods/design: The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care.

Discussion: The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices.

Trial registration: Current Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013. Date and Version Number: 27 August 2014 Version 5.

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Figures

**Fig. 1**
Flow chart of participant recruitment in the PRIMROSE trial

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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

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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

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