title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013. Date and Version Number: 27 August 2014 Version 5.
authors: 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.|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.
authors: David
authors: D
authors: Osborn
authors: 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.
authors: Alexandra
authors: A
authors: Burton
authors: 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.
authors: Kate
authors: K
authors: Walters
authors: 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.
authors: Irwin
authors: I
authors: Nazareth
authors: 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.
authors: Samira
authors: S
authors: Heinkel
authors: 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.
authors: Lou
authors: L
authors: Atkins
authors: 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.
authors: Ruth
authors: R
authors: Blackburn
authors: 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.
authors: Richard
authors: R
authors: Holt
authors: 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.
authors: Racheal
authors: R
authors: Hunter
authors: 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.
authors: Michael
authors: M
authors: King
authors: 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.
authors: Louise
authors: L
authors: Marston
authors: Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. s.michie@ucl.ac.uk.
authors: Susan
authors: S
authors: Michie
authors: 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.
authors: Richard
authors: R
authors: Morris
authors: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. steve.morris@ucl.ac.uk.
authors: Steve
authors: S
authors: Morris
authors: 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.
authors: Rumana
authors: R
authors: Omar
authors: Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.C.Peveler@soton.ac.uk.
authors: Robert
authors: R
authors: Peveler
authors: The McPin Foundation, 32-36 Loman Street, London, SE1 0EH, UK. VanessaPinfold@mcpin.org.
authors: Vanessa
authors: V
authors: Pinfold
authors: 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.
authors: Ella
authors: E
authors: Zomer
authors: 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.
authors: Thomas
authors: T
authors: Barnes
authors: Institute of Psychiatry, Psychology & Neuroscience, Kings College London, 16 De Crespigny Park, London, SE5 8AF, UK. thomas.craig@kcl.ac.uk.
authors: Tom
authors: T
authors: Craig
authors: 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.
authors: Hazel
authors: H
authors: Gilbert
authors: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. bengray@mcpin.org.
authors: Ben
authors: B
authors: Grey
authors: 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.
authors: Claire
authors: C
authors: Johnston
authors: 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.
authors: Judy
authors: J
authors: Leibowitz
authors: 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.
authors: Irene
authors: I
authors: Petersen
authors: 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.
authors: Fiona
authors: F
authors: Stevenson
authors: University of Northampton, Berrywood Hospital, Berrywood Drive, Upton, Northampton, NN5 6UD, UK. Sheila.Hardy@nhft.nhs.uk.
authors: Sheila
authors: S
authors: Hardy
authors: Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK. vanessarobinson331@yahoo.co.uk.
authors: Vanessa
authors: V
authors: Robinson
mesh_terms: D000328:Adult; D000368:Aged; D001521:Behavior Therapy; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D003627:Data Interpretation, Statistical; D006801:Humans; D001523:Mental Disorders / Q000150:complications / Q000523:psychology / Q000628:therapy*; D008875:Middle Aged; D018579:Patient Selection; D011320:Primary Health Care; D011788:Quality of Life; D012307:Risk Factors