Dataset Information

Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial.

ABSTRACT:

Background

The estimated 300,000 adults in Australia with severe mental illness (SMI) have markedly reduced life expectancy compared to the general population, mainly due to physical health comorbidities. Cardiovascular disease (CVD) is the commonest cause of early death and people with SMI have high rates of most modifiable risk factors, with associated quality of life (QoL) reduction. High blood pressure, smoking, dyslipidaemia, diabetes and obesity are major modifiable CVD risk factors. Poor delivery of recommended monitoring and risk reduction is a national and international problem. Therefore, effective preventive interventions to safeguard and support physical health are urgently needed in this population.

Methods

This trial used a rigorous process, including extensive piloting, to develop an intervention that delivers recommended physical health care to reduce CVD risk and improve QoL for people with SMI. Components of this intervention are integrated using the Flinders Program of chronic condition management (CCM) which is a comprehensive psychosocial care planning approach that places the patient at the centre of their care, and focuses on building their self-management capacity within a collaborative approach, therefore providing a recovery-oriented framework. The primary project aim is to evaluate the effectiveness and health economics of the CCM intervention. The main outcome measures examine CVD risk and quality of life. The second aim is to identify essential components, enablers and barriers at patient, clinical and organisational levels for national, sustained implementation of recommended physical health care delivery to people with SMI. Participants will be recruited from a community-based public psychiatric service.

Discussion

This study constitutes the first large-scale trial, worldwide, using the Flinders Program with this population. By combining a standardised yet flexible motivational process with a targeted set of evidence-based interventions, the chief aim is to reduce CVD risk by 20%. If achieved, this will be a ground-breaking outcome, and the program will be subsequently translated nationwide and abroad. The trial will be of great interest to people with mental illness, family carers, mental health services, governments and primary care providers because the Flinders Program can be delivered in diverse settings by any clinical discipline and supervised peers.

Trial registration

Australian and New Zealand Clinical Trials Registry, ACTRN12617000474358 . Registered on 31 March 2017.

SUBMITTER: Battersby M

PROVIDER: S-EPMC6042320 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial.

Battersby Malcolm M Kidd Michael R MR Licinio Julio J Aylward Philip P Baker Amanda A Ratcliffe Julie J Quinn Stephen S Castle David J DJ Zabeen Sara S Fairweather-Schmidt A Kate AK Lawn Sharon S

Trials 20180711 1

<h4>Background</h4>The estimated 300,000 adults in Australia with severe mental illness (SMI) have markedly reduced life expectancy compared to the general population, mainly due to physical health comorbidities. Cardiovascular disease (CVD) is the commonest cause of early death and people with SMI have high rates of most modifiable risk factors, with associated quality of life (QoL) reduction. High blood pressure, smoking, dyslipidaemia, diabetes and obesity are major modifiable CVD risk factor ...[more]

PMID: 29996886

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Project description:Interventions: We are assessing the impact of the National Bowel Cancer Screening Program (NBCSP) by comparing participation rates of people with and without Severe Mental Illness (SMI) and looking at health outcomes. We will be using data collected from Aug 2006 - latest available. We are linking data using Commonwealth data (NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database & the National Death Index) to compare bowel cancer screening participation in people with SMI to those from the general population. We will additionally link these to the NSW cancer registry and hospital data to examine care pathways from diagnosis through treatment and end-of-life care. We will also conduct a consultation with people with experience of SMI and Colorectal cancer and people with SMI in peer support roles who can provide their perspective on the barriers faced by people with SMI to gaining timely screening, diagnosis and optimal care. These participants will be recruited from New South Wales consumer organisations and organisations with a strong focus on provision of peer support and advocacy. We will use a semi structured group interview schedule to facilitate discussion of a single focus group of 15 people. The group will consist of both people with lived experience who have direct experience of bowel cancer (n=10), as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles (n=5). We will use this qualitative arm of the study to further develop our understanding of the quantitative findings. The consultation will also develop ideas on how to improve access to care. Primary outcome(s): Participation rates in the National Bowel Cancer Screening Program assessed using data from the NBCSP.[Person-years will be calculated from entry into the study (2006) (the date of commencement of the NBCSP) or from the year that people become eligible for screening (i.e. age 50), whichever occurs later.. This is a retrospective cohort study, so all of the outcomes have already occurred and were recorded in the administrative data. This will be assessed when we receive the data.];Colonoscopy rates assessed using data from the NBCSP [Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until colonoscopy. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.];Cancer diagnosis using data from the Australian Cancer Database[Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until cancer diagnosis. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Case control;Timing: Both

Dataset Information

Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial.

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