Evidence map›Paper›PMID 26868949›Full record

Trial reportTrials2016

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, Alexandra Burton, Kate Walters, Irwin Nazareth, Samira Heinkel, Lou Atkins, Ruth Blackburn, Richard Holt, Racheal Hunter, Michael King and 18 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

David OsbornDivision 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.
Alexandra BurtonDivision 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.
Kate WaltersDepartment 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.
Irwin NazarethDepartment 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.
Samira HeinkelDivision 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.
Lou AtkinsDivision 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.
Ruth BlackburnDivision 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.
Richard HoltHuman Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.I.G.Holt@soton.ac.uk.
Racheal HunterDepartment 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.
Michael KingDivision 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.
Louise MarstonDepartment 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.
Susan MichieHuman Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. s.michie@ucl.ac.uk.
Richard MorrisUCL 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.
Steve MorrisSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. steve.morris@ucl.ac.uk.
Rumana OmarDepartment 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.
Robert PevelerHuman Development and Health Academic Unit, Faculty of Medicine, University of Southampton, University Rd, Southampton, SO17 1BJ, UK. R.C.Peveler@soton.ac.uk.
Vanessa PinfoldThe McPin Foundation, 32-36 Loman Street, London, SE1 0EH, UK. VanessaPinfold@mcpin.org.
Ella ZomerDepartment 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.
Thomas BarnesDepartment 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.
Tom CraigInstitute of Psychiatry, Psychology & Neuroscience, Kings College London, 16 De Crespigny Park, London, SE5 8AF, UK. thomas.craig@kcl.ac.uk.
Hazel GilbertDepartment 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.
Ben GreySchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. bengray@mcpin.org.
Claire JohnstonCamden 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.
Judy LeibowitzCamden 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.
Irene PetersenDepartment 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.
Fiona StevensonDepartment 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.
Sheila HardyUniversity of Northampton, Berrywood Hospital, Berrywood Drive, Upton, Northampton, NN5 6UD, UK. Sheila.Hardy@nhft.nhs.uk.
Vanessa RobinsonRethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK. vanessarobinson331@yahoo.co.uk.

Funding

Department of Health RP-PG-0609-10156
6 · The paper itself

Abstract

backgroundPeople 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/

designThe 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 registrationCurrent Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013. Date and Version Number: 27 August 2014 Version 5.

Indexed as

Behavior TherapyAdultAgedCardiovascular DiseasesCost-Benefit AnalysisData Interpretation, StatisticalHumansMental DisordersMiddle AgedPatient SelectionPrimary Health CareQuality of LifeRisk Factors

Identifiers

PMID26868949
PMCPMC4751703

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.