The University of Southampton
University of Southampton Institutional Repository

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

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
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
Background: people with severe mental illnesses, including psychosis, have an increased risk of cardiovascular disease. We aimed to evaluate the effects of a primary care intervention on decreasing total cholesterol concentrations and cardiovascular disease risk in people with severe mental illnesses.

Methods: we did this cluster randomised trial in general practices across England, with general practices as the cluster unit. We randomly assigned general practices (1:1) with 40 or more patients with severe mental illnesses using a computer-generated random sequence with a block size of four. Researchers were masked to allocation, but patients and general practice staff were not. We included participants aged 30–75 years with severe mental illnesses (schizophrenia, bipolar disorder, or psychosis), who had raised cholesterol concentrations (5·0 mmol/L) or a total:HDL cholesterol ratio of 4·0 mmol/L or more and one or more modifiable cardiovascular disease risk factors. Eligible participants were recruited within each practice before randomisation. The Primrose intervention consisted of appointments (≤12) with a trained primary care professional involving manualised interventions for cardiovascular disease prevention (ie, adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking). Treatment as usual involved feedback of screening results only. The primary outcome was total cholesterol at 12 months and the primary economic analysis outcome was health-care costs. We used intention-to-treat analysis. The trial is registered with Current Controlled Trials, number ISRCTN13762819.

Findings: between Dec 10, 2013, and Sept 30, 2015, we recruited general practices and between May 9, 2014, and Feb 10, 2016, we recruited participants and randomly assigned 76 general practices with 327 participants to the Primrose intervention (n=38 with 155 patients) or treatment as usual (n=38 with 172 patients). Total cholesterol concentration data were available at 12 months for 137 (88%) participants in the Primrose intervention group and 152 (88%) participants in the treatment-as-usual group. The mean total cholesterol concentration did not differ at 12 months between the two groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI −0·22 to 0·29; p=0·788). This result was unchanged by pre-agreed supportive analyses. Mean cholesterol decreased over 12 months (−0·22 mmol/L [1·1] for Primrose vs −0·36 mmol/L [1·1] for treatment as usual). Total health-care costs (£1286 [SE 178] in the Primrose intervention group vs £2182 [328] in the treatment-as-usual group; mean difference −£895, 95% CI −1631 to −160; p=0·012) and psychiatric inpatient costs (£157 [135] vs £956 [313]; −£799, −1480 to −117; p=0·018) were lower in the Primrose intervention group than the treatment-as-usual group. Six serious adverse events of hospital admission and one death occurred in the Primrose group (n=7) and 23, including three deaths, occurred in the treatment-as-usual group (n=18).

Interpretation: total cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important.

Funding: National Institute of Health Research Programme Grants for Applied Research.
2215-0366
145-154
Holt, Richard
d54202e1-fcf6-4a17-a320-9f32d7024393
Osborn, David
72ee8dea-7ac8-4b9f-bb2b-314b33f33621
Burton, Alexandra
826aba3a-a479-4b8a-9358-8afe10e25815
Hunter, Rachael
155068d4-d49a-4180-8eb0-0c549aa7f95c
Marston, Louise
258cc87f-2cf7-49de-9498-fc659a5ffde7
Atkins, Louise
5e0e7b1f-e3da-4b50-a26f-3eaa5f5c9b34
Barnes, Thomas
b99a2b41-dfd0-4233-9838-f1607bfd5237
Blackburn, Ruth
070470c5-a390-4112-a67e-707221dcd935
Craig, Thomas
ed19b5de-2d1f-4eef-a967-809c7e43db56
Gilbert, Hazel
ac6d2ea2-4360-46f4-80b9-d1c5061dbbce
Heinkel, Samira
ac792c5e-2677-4736-8c4a-25ef2bd5da39
King, Michael
cf8c59d9-802d-45b8-8413-be0d41446c0d
Michie, Susan
30e955ad-9f99-4824-91f9-876c71b4e144
Morris, Richard
55b5cc3b-a0b9-463e-9cd6-1f716e20f54b
Nazareth, Irwin
c0afb415-03b2-4898-8303-61d6badfd17c
Omar, Rumana
2aebe59b-3665-4201-b403-a30d3dbe1f0b
Peterson, Irene
a5c32980-ef01-4f95-ba61-7871aeb74d00
Peveler, Robert
17a84e18-df30-44d3-8e8f-daf7c33ad8f4
Pinfold, Vanessa
cbab736d-7c1b-4c8f-a3cd-ac97d8ace518
Walters, Kate
b220bb54-d044-4a8a-9708-0aacc4af31d4
Holt, Richard
d54202e1-fcf6-4a17-a320-9f32d7024393
Osborn, David
72ee8dea-7ac8-4b9f-bb2b-314b33f33621
Burton, Alexandra
826aba3a-a479-4b8a-9358-8afe10e25815
Hunter, Rachael
155068d4-d49a-4180-8eb0-0c549aa7f95c
Marston, Louise
258cc87f-2cf7-49de-9498-fc659a5ffde7
Atkins, Louise
5e0e7b1f-e3da-4b50-a26f-3eaa5f5c9b34
Barnes, Thomas
b99a2b41-dfd0-4233-9838-f1607bfd5237
Blackburn, Ruth
070470c5-a390-4112-a67e-707221dcd935
Craig, Thomas
ed19b5de-2d1f-4eef-a967-809c7e43db56
Gilbert, Hazel
ac6d2ea2-4360-46f4-80b9-d1c5061dbbce
Heinkel, Samira
ac792c5e-2677-4736-8c4a-25ef2bd5da39
King, Michael
cf8c59d9-802d-45b8-8413-be0d41446c0d
Michie, Susan
30e955ad-9f99-4824-91f9-876c71b4e144
Morris, Richard
55b5cc3b-a0b9-463e-9cd6-1f716e20f54b
Nazareth, Irwin
c0afb415-03b2-4898-8303-61d6badfd17c
Omar, Rumana
2aebe59b-3665-4201-b403-a30d3dbe1f0b
Peterson, Irene
a5c32980-ef01-4f95-ba61-7871aeb74d00
Peveler, Robert
17a84e18-df30-44d3-8e8f-daf7c33ad8f4
Pinfold, Vanessa
cbab736d-7c1b-4c8f-a3cd-ac97d8ace518
Walters, Kate
b220bb54-d044-4a8a-9708-0aacc4af31d4

Holt, Richard, Osborn, David, Burton, Alexandra, Hunter, Rachael, Marston, Louise, Atkins, Louise, Barnes, Thomas, Blackburn, Ruth, Craig, Thomas, Gilbert, Hazel, Heinkel, Samira, King, Michael, Michie, Susan, Morris, Richard, Nazareth, Irwin, Omar, Rumana, Peterson, Irene, Peveler, Robert, Pinfold, Vanessa and Walters, Kate (2018) 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. The Lancet Psychiatry, 5 (2), 145-154. (doi:10.1016/S2215-0366(18)30007-5).

Record type: Article

Abstract

Background: people with severe mental illnesses, including psychosis, have an increased risk of cardiovascular disease. We aimed to evaluate the effects of a primary care intervention on decreasing total cholesterol concentrations and cardiovascular disease risk in people with severe mental illnesses.

Methods: we did this cluster randomised trial in general practices across England, with general practices as the cluster unit. We randomly assigned general practices (1:1) with 40 or more patients with severe mental illnesses using a computer-generated random sequence with a block size of four. Researchers were masked to allocation, but patients and general practice staff were not. We included participants aged 30–75 years with severe mental illnesses (schizophrenia, bipolar disorder, or psychosis), who had raised cholesterol concentrations (5·0 mmol/L) or a total:HDL cholesterol ratio of 4·0 mmol/L or more and one or more modifiable cardiovascular disease risk factors. Eligible participants were recruited within each practice before randomisation. The Primrose intervention consisted of appointments (≤12) with a trained primary care professional involving manualised interventions for cardiovascular disease prevention (ie, adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking). Treatment as usual involved feedback of screening results only. The primary outcome was total cholesterol at 12 months and the primary economic analysis outcome was health-care costs. We used intention-to-treat analysis. The trial is registered with Current Controlled Trials, number ISRCTN13762819.

Findings: between Dec 10, 2013, and Sept 30, 2015, we recruited general practices and between May 9, 2014, and Feb 10, 2016, we recruited participants and randomly assigned 76 general practices with 327 participants to the Primrose intervention (n=38 with 155 patients) or treatment as usual (n=38 with 172 patients). Total cholesterol concentration data were available at 12 months for 137 (88%) participants in the Primrose intervention group and 152 (88%) participants in the treatment-as-usual group. The mean total cholesterol concentration did not differ at 12 months between the two groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI −0·22 to 0·29; p=0·788). This result was unchanged by pre-agreed supportive analyses. Mean cholesterol decreased over 12 months (−0·22 mmol/L [1·1] for Primrose vs −0·36 mmol/L [1·1] for treatment as usual). Total health-care costs (£1286 [SE 178] in the Primrose intervention group vs £2182 [328] in the treatment-as-usual group; mean difference −£895, 95% CI −1631 to −160; p=0·012) and psychiatric inpatient costs (£157 [135] vs £956 [313]; −£799, −1480 to −117; p=0·018) were lower in the Primrose intervention group than the treatment-as-usual group. Six serious adverse events of hospital admission and one death occurred in the Primrose group (n=7) and 23, including three deaths, occurred in the treatment-as-usual group (n=18).

Interpretation: total cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important.

Funding: National Institute of Health Research Programme Grants for Applied Research.

Text Clinical and cost-effectiveness of an intervention for reducing cholesterol - Version of Record
Download (403kB)
Text Osborn et al 2018 - Proof
Download (393kB)

More information

Accepted/In Press date: 1 April 2016
e-pub ahead of print date: 22 January 2018
Published date: February 2018

Identifiers

Local EPrints ID: 417301
URI: https://eprints.soton.ac.uk/id/eprint/417301
ISSN: 2215-0366
PURE UUID: 129c2384-b4ed-4883-ab39-1fac653be137
ORCID for Richard Holt: ORCID iD orcid.org/0000-0001-8911-6744

Catalogue record

Date deposited: 29 Jan 2018 17:30
Last modified: 24 Jul 2018 04:01

Export record

Altmetrics

Contributors

Author: Richard Holt ORCID iD
Author: David Osborn
Author: Alexandra Burton
Author: Rachael Hunter
Author: Louise Marston
Author: Louise Atkins
Author: Thomas Barnes
Author: Ruth Blackburn
Author: Thomas Craig
Author: Hazel Gilbert
Author: Samira Heinkel
Author: Michael King
Author: Susan Michie
Author: Richard Morris
Author: Irwin Nazareth
Author: Rumana Omar
Author: Irene Peterson
Author: Robert Peveler
Author: Vanessa Pinfold
Author: Kate Walters

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×