Despite an overall improvement in life expectancy in recent years, the mortality gap is actually widening between people with severe mental illness and everyone else. Unfortunately, life expectancy in people with severe mental illness (SMI) is around 15-20 years less than the general population (Chesney, 2014).
A considerable proportion of the increased morbidity and mortality is driven by comorbid physical illnesses (Hayes, 2017). People with SMI have a higher prevalence of comorbid physical health conditions (Reilly, 2015) such as cardiovascular diseases, respiratory diseases and other conditions (Brown et al., 2010). People with SMI have a particularly high risk of developing conditions such as cardiovascular disease (CVD), for reasons associated with the underlying mental disorder and health risk behaviours such as physical inactivity, smoking, and poor diet (Vancampfort, 2017). Individuals with severe mental illness have approximately 1.5 to 2 times higher prevalence of diabetes, dyslipidemia, hypertension, and obesity than the general population, which are risk factors for CVD (Newcomer & Hennekens, 2007).
People with SMI urgently need interventions to address their multiple co-occurring risk factors, including diabetes, hypertension, dyslipidemia, tobacco smoking, and obesity for prevention of CVD (Liu et al., 2017).
Methods
To address this major health challenge, Daumit et al. (2020) conducted a randomised controlled trial in four community mental health outpatient programs in Maryland. The authors aimed to determine the effectiveness of an 18-month multifaceted intervention incorporating behavioural counselling, care coordination, and care management for overall cardiovascular risk reduction in adults with SMI. Participants were randomly assigned to intervention or control groups using computer-generated randomisation allocation sequences. The participants and intervention staff were aware of group assignment, but the data collectors were blinded.
The intervention
Individually tailored cardiovascular disease risk reduction coaching sessions (weekly 20-30 minutes sessions for the first 6 months and at least every 2 weeks for the next 12 months) provided by a health coach and a nurse based at the community mental health organisation. The nurse and health coach also collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. The programs also offered physical activity classes and consultation on serving healthier meals for both intervention and control participants.
Outcome
The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), from baseline to 18 months. This scale estimates the 10-year probability of a CVD event, i.e. risk of coronary heart disease, heart failure.
Results
269 participants were included in the study and randomisation; 132 in intervention and 137 in control group.
- The results showed statistically significant reductions of global FRS (reduction of overall cardiovascular risk) at 18-month follow-up in adults with SMI
- Rates of tobacco smoking were statistically significantly reduced in the intervention group compared with the control group.
- Differences of blood pressure and lipid risk score components were not statistically significant between group, however, the direction of change were toward improvement in the intervention group.
Conclusions
The study supports the use of the intervention embedded in routine outpatient specialty mental health care setting. The authors concluded:
This intervention provides the means to substantially reduce health disparities in this high-risk population.
Strengths and limitations
The intervention incorporated strategies to address multiple cardiovascular risk factors to facilitate health behaviour change with high follow-up rates for the outcome data. The trial maintained Consolidated Standards of Reporting Trials (CONSORT) reporting guideline and data were analysed on the principle of intention to treat.
Some limitations and lack of clarity of the reporting of the trial need consideration. We know the template for intervention description and replication (TIDieR) checklist was created to improve standards of reporting and describing interventions, in order to allow researchers to replicate or build on previous research (Hoffmann et al. 2014). However, in line with the TIDieR checklist, sufficient information on the tailoring and modification of the intervention based on each risk group, modality and intensity of intervention delivery, fidelity of the intervention, adherence to intervention was not reported. This information would make the trial more transparent and replicable, which is vital for implementation and scale up of an intervention.
Additionally, due to its complex and multi-faceted character, it was difficult for the researchers to specify which aspects of the intervention were causing these risk reductions. Was it the behavioural counselling, the care coordination or maybe the impact of both? Moreover, for which risk groups was the intervention most effective? This was not explored.
The baseline measures of some risk factors were higher for the control group compared to the intervention group, which might have some impact on the observed difference in the follow-up.
The outcome was a risk score rather than actual clinical events. Though FRS was the most widely used score available at trial, it was difficult to follow the absolute and relative reduction of risk for a non-expert reader in this field. As a reader, it would have been easier to conceive the changes in the individual risk factors and then the overall risk reduction. The trial was designed with the power to detect the primary outcome FRS, but not the changes in individual cardiovascular risk factors. The study reported statistically significant difference for smoking cessation only. Overall, the result of this study was reported on a statistically “significant” and “non-significant” basis. However, there is a movement of interpreting the results in terms of strength of evidence (Munafò et al., 2015) and reporting of clinically meaningful difference.
In the protocol of this study, the author mentioned coordination among the primary care provider, mental health provider, psychiatrist, staff and social support provider. However, in this paper the authors acknowledged that although the intervention was embedded in a community mental health organisation and the intervention team worked closely with mental health staff and practitioners, there was no formal relationship with primary care practitioners. Developing effective coordination is clearly a significant issue. The authors mentioned:
[…] a more formal integrated care structure, the intervention could have resulted in even greater risk reduction.
In fact, creating this effective integrated care system is considered as a major practical challenge.
Implications for practice
Appropriate timely health prevention, promotion and monitoring activities to reduce health inequalities in people with SMI are needed. Considering cardiovascular disease (CVD) as a major cause of mortality and morbidity, the intervention to address cardiovascular risk factors, embedded in routine mental health care for adults with SMI are important to implement.
The authors mentioned that integrated care programs could be a way for implementing the intervention. Organisations may choose to target persons with SMI with higher baseline cardiovascular risk. The study recommended the use of this tailored intervention embedded in routine outpatient mental health care setting to address cardiovascular risk factors for this population. However, evidence on this area is mixed. A previous review showed that despite a widespread increase in programs incorporating physical health programs into mental health settings, care coordination interventions to date have not resulted in cardiovascular risk improvements for persons with SMI (Murphy et al. 2018). In fact, implementation of such interventions in practical settings within routine care might be challenging. Also it is important to clarify how the interventions were tailored for specific risk groups and the mechanisms of driving the risk reduction, and how this can be replicated, refined and optimised before agreeing on implications for practice.
Statement of interest
None.
Links
Primary paper
Daumit GL, Dalcin AT, Dickerson FB, et al. Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial. JAMA Netw Open.2020;3(6):e207247.
Other references
Chesney, E., Goodwin, G.M. & Fazel, S. Risks of all-cause and suicide mortality in mental disorders: a meta-review. World Psychiatry 2014; 13(2):153–160.
Brown, S. Kim M, Mitchell C, Inskip H. et al. Twenty-five year mortality of a community cohort with schizophrenia.The British journal of psychiatry : the journal of mental science 2010; 196(2):116–21.
Hayes JF, Marston L, Walters K, King MB, Osborn DPJ. Mortality gap for people with bipolar disorder and schizophrenia: UK-based cohort study 2000-2014. British Journal of Psychiatry 2017;211:175-81.
Hoffmann TC, Glasziou PP, Boutron I, et al. (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
Liu NH, Daumit GL, Dua T, et al. Excess mortality in persons with severe mental disorders: a multilevel intervention framework and priorities for clinical practice, policy and research agendas. World Psychiatry. 2017;16 (1):30-40.
Marcus R. Munafò, PhD, E. Paul Wileyto, PhD, Guidelines on Statistical Reporting at Nicotine & Tobacco Research, Nicotine & Tobacco Research, Volume 17, Issue 11, November 2015, Pages 1295–1296.
Murphy KA, Daumit GL, Stone E, McGinty EE. Physical health outcomes and implementation of behavioural health homes: a comprehensive review. Int Rev Psychiatry. 2018;30(6):224-241.
Newcomer JW, Hennekens CH. Severe Mental Illness and Risk of Cardiovascular Disease. JAMA.2007;298(15):1794–1796.
Reilly S, Olier I, Planner C, Doran T, Reeves D, Ashcroft DM, et al. Inequalities in physical comorbidity: a longitudinal comparative cohort study of people with severe mental illness in the UK. BMJ Open 2015;5(12):e009010.
Vancampfort D, Firth J, Schuch FB, Rosenbaum S, Mugisha J, Hallgren M, et al. Sedentary behavior and physical activity levels in people with schizophrenia, bipolar disorder and major depressive disorder: a global systematic review and meta-analysis. World Psychiatry 2017;16:308-15.
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