Results Summary
What was the research about?
People with serious mental illness like bipolar disorder or schizophrenia often don’t receive the physical health care they need. Community mental health centers can help people with serious mental illness manage their health and prevent later health problems.
In this study, the research team gave different kinds of health and wellness support to patients with serious mental illness. All patients in the study worked with wellness coaches. These coaches were staff at mental health centers who received special training. They taught patients skills to help them manage their health and health care. The team then compared two types of extra support:
- Nurse-supported: Nurses helped patients get health care and improve their health and wellness. The nurses also advised the wellness coaches about working with the patients.
- Self-directed: Patients got online or paper resources with information designed for them. Resources included worksheets and manuals to help them improve behaviors like eating healthy food and exercising.
What were the results?
The two types of extra support had about the same success in helping patients with serious mental illness. By the end of the study, patients in both groups reported increased
- Involvement in their health care
- Doctor visits
- Quality of life
- Satisfaction with their care
They were also more likely to get physical health care when they needed it. Patients reported that their mental health improved. At the same time, they viewed their physical health as being worse. Patients were no more or less likely to take their medicines for mental illness than before the study.
Who was in the study?
The study included 1,229 adults with serious mental illness from mental health centers in rural Pennsylvania. Of these, 90 percent were white, 8 percent were black, and 2 percent were another race. The average patient age was 43, and 63 percent were women. Patients had major depressive disorder (38 percent), bipolar disorder (27 percent), schizoaffective disorder (16 percent), schizophrenia (10 percent), or other mental illnesses (8 percent). All patients had Medicaid insurance.
What did the research team do?
The research team assigned 11 mental health centers by chance to one of the two programs offering extra support: nurse-supported or self-directed.
Patients filled out surveys at 6, 12, 18, and 24 months. The team also looked at patients’ Medicaid claims to track doctor visits and medicine use.
The research team developed the study with help from people with serious mental illness, clinicians, and others who work in mental health.
What were the limits of the study?
At the end of the study, the team didn’t have survey or claims data for 16 percent of patients. Results might have been different if the team had data for more patients. The study didn’t look at how well the extra support programs worked compared with usual mental health care. Most patients in this study were white and all lived in rural areas. Future research could test the two types of extra support with patients of other backgrounds.
How can people use the results?
Mental health centers can think about training staff as wellness coaches and letting patients choose the type of extra support that works best for them.
Professional Abstract
Objective
To compare the effectiveness of two interventions—wellness coaching plus a provider-supported integrated approach or a self-directed approach—on patient activation in care, health status, and engagement in primary or specialty care among adults with serious mental illness receiving services at community mental health centers (CMHCs)
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 1,229 adults with serious mental illness who had Medicaid and received care at 11 participating CMHCs |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient activation in care, mental and physical health status, engagement in primary/specialty care Secondary: hope, quality of life, functional status, care satisfaction, medication adherence, emergency care, and lab monitoring |
| Timeframe | Up to 2-year follow-up for study outcomes |
In this cluster randomized controlled trial, researchers assigned 11 CMHCs to deliver either a provider-supported or a self-directed intervention to help participants with serious mental illness address chronic disease risk factors and promote recovery. Both interventions trained CMHC staff as wellness coaches. In the provider-supported intervention, nurses assisted participants with accessing services and monitoring physical health. They also advised the wellness coaches on how to help patients develop goals promoting positive health behaviors, including smoking cessation and improved nutrition. Participants in the self-directed intervention could access a web portal with individually tailored content, including health and wellness trackers. Those who preferred not to use the portal received paper-based resources.
The study included 1,229 adults with serious mental illness who had Medicaid and received behavioral health services at 1 of 11 CMHCs in rural Pennsylvania. Participants had diagnoses of major depressive disorder (38%), bipolar disorder (27%), schizoaffective disorder (16%), schizophrenia (10%), and other mental illnesses (8%). Of these participants, 90% were white, 8% were black, and 2% were another race. The average participant age was 43, and 63% were female.
The research team collected self-reported outcomes from patient surveys at 6, 12, 18, and 24 months. They reviewed Medicaid claims data at the same intervals to measure participants’ engagement in care (i.e., primary, specialty, and emergent care visits; medication adherence; and lab tests).
An advisory board including people diagnosed with serious mental illness, their advocates, clinicians, and others involved in addressing serious mental illness provided input to the study.
Results
At the final follow-up, after either 18 or 24 months depending on enrollment date, the two groups did not differ on any of the study outcomes. Increases in patient activation in care differed at earlier time points, with the provider-supported group experiencing a greater increase at six months (p<0.0001) and the self-directed group experiencing a greater increase at 18 months (p<0.0001). In addition, women experienced greater improvement in activation than men in the provider-supported group, while men’s average activation score increased more than women’s in the self-directed group (p=0.0019).
Also at the final follow-up, participants in both groups reported improved mental health status (p<0.0001) and showed more engagement in primary/specialty care (p<0.0001). Perceived physical health status declined (p<0.0001) for both groups.
Participants in both groups improved on several secondary outcomes, including hope (p=0.0058), quality of life (p=0.0014), satisfaction with care (p=0.0021), emergent care use (p=0.0020), lab monitoring (p=0.0029), and diabetes medication adherence (p<0.0001). Adherence to antipsychotic medications and medications for other physical ailments did not change significantly for either group.
Limitations
A 16% overall loss to follow-up may have biased the results. In addition, without comparing the interventions to usual care, it is unclear whether or not the observed changes in both groups are attributable to the interventions studied. Most participants were white, and all lived in rural Pennsylvania. Results might be different for participants of other backgrounds.
Conclusions and Relevance
Overall, the interventions performed similarly. This finding suggests that CMHCs may consider training staff as wellness coaches and offering patients the choice between the provider-supported or self-directed interventions to improve their health and wellness.
Future Research Needs
Future research could test these interventions in new settings and with other populations at risk for physical health challenges.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- Reviewers were concerned that the abstract overstated the inferences made from the study results, particularly because the highlighted results did not appear to come directly from the listed study objectives. The researchers responded that the analyses presented in the abstract were indeed all planned analyses, and that their results were robust enough to support the study conclusions. They did revise the abstract to include the primary aim results so that the Results section is better aligned with the study objectives.
- Reviewers particularly noted the strong inferences made about the moderating effects of gender on treatment outcomes over time and criticized the analytic approach to testing these moderating effects. The researchers rebutted that their approach to testing for the moderating effect of gender was appropriate because they first wanted to determine whether actual differences over time between the two treatments were present but masked by gender differences in outcomes.
- The reviewers were unclear about whether this cluster-randomized trial included 10 or 11 clinics, because both numbers were used. The researchers clarified the report to show that 11 clinics entered the trial, but that the two smallest clinics had similar enough characteristics that their data were combined.
- Reviewers were concerned that the study did not adequately account for multiple outcomes when determining the sample size for the study. In addition, reviewers felt it was unclear whether the study had enough power to test the heterogeneity of treatment effects. The researchers explained that they used the best available historical effect sizes for the primary outcomes to calculate sample size, and clarified that the heterogeneity of treatment effects analyses should be considered exploratory because the study was not adequately powered for those analyses.
- The reviewers commented on the significant loss-to-follow-up of participants between baseline and final outcome data collection, expressing concern because there were differences between completers and those who didn’t complete on some key measures. The researchers responded that they did not understand why completers differed from those who didn’t complete, but that they did account for it in their analyses.
The reviewers noted the significant and unexpected finding that patient-reported physical health status worsened over time and interpreted this as indication of the difficulty in improving health status within this population, even after improvement in mental health and patient activation. The researchers disagreed with this interpretation; they interpreted the worsening health status as a consequence of patients’ improved understanding and acknowledgement of their health brought about by their increased engagement in preventive and maintenance care. The researchers felt that longer periods of observation would demonstrate a gradual improvement in physical health as patient engagement translated into better health behavior.