Results Summary
What was the research about?
When primary care clinics offer mental health care on-site, it’s called co-located care. But care teams at clinics with co-located care may not work together or share information about patients’ care. In integrated behavioral health, or IBH, mental health staff, like counselors and psychologists, and primary care clinicians, like doctors and nurse practitioners, work together to treat patients. They also share records and data systems.
In this study, the research team looked at whether a program to help clinics use IBH improved well-being among patients with physical and mental health conditions. They also wanted to see if the program improved how well primary and behavioral health care teams worked together. The research team compared clinics that did and didn’t receive the program.
What were the results?
After two years, patients in clinics that did and didn’t receive the IBH program didn’t differ in:
- Anxiety, depression, or fatigue
- Ability to fall and stay asleep
- Disability, physical fitness, and ability to do activities
- Pain and how pain interfered with their life
- How often they took their medicine as directed
- Self-care activities and social functioning
- Use of care
Compared with clinics that didn’t receive the program, clinics that did:
- Were better at tracking patient information and care
- Didn’t differ in provider empathy and ability to communicate effectively with patients
Who was in the study?
The study included 2,426 patients receiving care in one of 41 primary care clinics with co-located care across the United States. Patients had at least one long-term health problem and one long-term mental health condition or at least three long-term health problems. Of these patients, 77 percent were White, 12 percent were African American, 3 percent were Asian, and 2 percent were Native Hawaiian or Pacific Islander. Also, 1 percent were American Indian or Alaska Native and 7 percent were another race or preferred not to say; 7 percent were Hispanic. The average age was 62, and 66 percent were women.
What did the research team do?
The research team assigned clinics by chance to receive the IBH program or not. Staff at clinics assigned to the program could learn about IBH using an online course and a workbook. They received access to an online learning community and coaching services.
At the start of the study and one and two years later, the research team surveyed patients and clinic staff.
Patients, family members, clinicians, and behavioral health staff helped design the study.
What were the limits of the study?
The research team let clinics decide when to use the program and which parts to use. Results may have differed if the team required clinics to use the program within a set amount of time or in a certain way.
Future studies could look at other ways to encourage IBH in primary care.
How can people use the results?
Primary care clinics can use the results when looking for ways to improve how well mental health and primary care providers work together in patient care.
Professional Abstract
Objective
(1) To compare the effectiveness of using versus not using a training program designed to improve the integration of behavioral health and primary care in settings of co-located care in improving patient-reported functioning and well-being; (2) To describe the effect of the program on the integration of behavioral health and primary care services
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 2,426 primary care patients ages 18 and older who had at least 1 chronic medical condition and 1 chronic behavioral health condition or at least 3 chronic medical conditions; patients received services at 1 of 41 primary care practices where behavioral health and primary care providers are co-located |
Interventions/ Comparators |
|
Outcomes | Primary: patient-reported physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, pain intensity, and pain interference Secondary: patient-reported medication adherence; engagement in self-care; provider communication and empathy with patients; utilization of care; disability; physical fitness; primary care staff-reported changes in measures of practice integration, which include improvements in practice workflow, workspace arrangement, and infrastructure; information sharing; case identification; clinical services; and patient engagement |
Timeframe | 2-year follow-up |
This cluster-randomized controlled trial compared the effectiveness of an integrated behavioral health (IBH) training program versus usual care in improving patient-reported physical function and well-being. The trial also examined the effect of the program on the integration of behavioral health and primary care services.
Researchers randomly assigned primary care practices to either receive the IBH training program or to provide usual care. The IBH program guided primary care practices through the process of integrating behavioral health into their practices. The program included an online curriculum, a practice redesign implementation workbook, remote quality improvement coaching services, and access to an online learning community. Practices assigned to usual care delivered services without receiving the program.
The study included 2,426 adult patients receiving services at one of 41 primary care practices across the United States. Of these patients, 77% were White, 12% were African American, 3% were Asian, 2% were Native Hawaiian or Pacific Islander, 1% were American Indian or Alaska Native, and 7% identified as another race or preferred not to say; 7% were Hispanic. The average age was 62, and 66% were female.
Researchers surveyed patients with recent or upcoming appointments at baseline and one and two years later. Researchers also surveyed four to five staff or providers in each practice at study enrollment and one and two years later.
Patients, family members, clinicians, and behavioral health staff, including counselors and psychologists, helped design the study.
Results
At two years, patients treated at practices that received the IBH program and patients treated at practices providing usual care did not differ significantly in physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, pain intensity, or pain interference.
Compared with practices providing usual care, practices that received the IBH program had better staff ratings of practice workflow for tracking patient information and care (p=0.02). The groups did not differ significantly in other secondary outcomes.
Limitations
Researchers gave practices flexibility in deciding when and the degree to which they engaged in the program, which may have affected the effectiveness of the program.
Conclusions and Relevance
In this study, patient-reported outcomes did not differ among patients receiving care in primary care practices enrolled in the IBH program versus patients receiving care in practices with usual care. Practices in the IBH program improved more on ratings of practice workflow than practices in usual care, but not on other measures of practice integration.
Future Research Needs
Future research could examine other ways to encourage the integration of behavioral health care in primary care settings.
COVID-19-Related Study
Determining the Effect of the COVID-19 Pandemic on a Program to Integrate Behavioral Health into Primary Care Practices
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
When primary care clinics offer mental health care on-site, it’s called co-located care. But care teams at clinics with co-located care may not work well together. Before the pandemic, a research team was examining a program to help clinics with co-located care use integrated behavioral health, or IBH. In IBH, mental health staff, like counselors, and primary care clinicians, like doctors and nurses, work together to treat patients. They share records and data systems. The research team was looking at whether the program improved well-being among patients with physical and mental health problems.
The research team assigned clinics by chance to take part in the IBH program or to provide usual care. Staff at clinics that took part in IBH could learn about IBH using an online course and a workbook. They also received access to online coaching and a learning community. Usual care was the care patients normally received at the clinic.
In this study, the research team wanted to learn whether burden from COVID-19 affected how well the IBH program worked to improve patients’ well-being. To measure the burden of COVID-19 on patients, the team asked patients how COVID-19 affected their lives and their communities. To measure the burden at each clinic, the team looked at how many people in the area around the clinic didn’t have jobs or had died from COVID-19.
What were the results?
The burden from COVID-19 didn’t change how well the IBH program worked to improve patients’:
- Ability to do daily activities
- Depression
- Fatigue
- Sleep problems
- Social functioning
- Level of pain and how much pain interfered with daily life
Who was in the study?
The study included 2,225 patients receiving care at one of 41 primary care clinics with co-located care across the United States. Patients had at least one long-term health problem and one long-term mental health problem or at least three long-term health problems. Of patients, 76 percent were White, 12 percent were African American, 3 percent were Asian, and 2 percent were Native Hawaiian or Pacific Islander. Also, 1 percent were American Indian or Alaska Native, and 6 percent were another race or preferred not to say; 7 percent were Hispanic. The average age was 64, and 66 percent were women.
What did the research team do?
The research team surveyed patients when the pandemic began and asked if COVID-19 had affected their lives. The team used statistical models to see if the burden from COVID-19 affected how well the program worked to improve patient well-being.
Patients and families, mental health staff, primary care clinicians, insurers, healthcare organizations, and state and federal policy makers gave input on the study.
What were the limits of the study?
The research team did not have a standard way to measure COVID-19 burden. Results may have differed with a standard measure.
How can people use the results?
Primary care clinics can use these results when considering ways to provide mental health care for their patients.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
With co-located care, primary care clinics offer both primary care and behavioral health care in the same location. But behavioral health staff, like counselors and psychologists, may have different hours than the primary care clinicians and may use different appointment systems and medical records. As a result, clinics may have difficulty coordinating primary care and behavioral health services to meet patient needs.
In another PCORI-funded study, researchers conducted a trial to examine whether using an intervention to promote integrated behavioral health, or IBH, in clinics with co-located care improved patient-reported outcomes. The intervention included an online curriculum, a practice redesign implementation workbook, remote quality improvement coaching services, and access to an online learning community.
The onset of the COVID-19 pandemic happened during the trial. As a result, primary care clinics may have diverted resources away from efforts to integrate primary care and behavioral health care and toward efforts to address patient and staff burden from the COVID-19 pandemic.
Objective
To determine whether burden from the COVID-19 pandemic had an impact on the effectiveness of the IBH intervention’s ability to improve patient-reported functioning and well-being
Study Design
Design Element | Description |
---|---|
Design | Quasi-experimental |
Population | 2,225 primary care patients ages 18 and older who had at least 1 chronic medical condition and 1 chronic behavioral health condition or at least 3 chronic medical conditions and who received services in 1 of 41 primary care clinics with co-located care |
Interventions/Comparators |
|
Outcomes | Patient-reported physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, pain intensity, and pain interference |
Data Collection Timeframe | April 29, 2020–January 8, 2021 |
This natural experiment examined how the COVID-19 pandemic affected the effectiveness of an IBH intervention’s ability to improve patient-reported physical function and well-being among patients receiving care at primary care clinics with co-located care.
Researchers had randomly assigned primary care clinics to receive the IBH intervention or to provide usual care. They had also surveyed patients receiving care at the clinics about physical function and well-being outcomes at study enrollment. Approximately 30 months later, when the COVID-19 pandemic began, researchers surveyed patients again about their experience with COVID-19 and its burden. Researchers assessed each clinic’s level of COVID-19 burden using data on COVID-19 incidence and deaths as well as unemployment statistics. Researchers used mixed linear models to understand how interaction effects between intervention receipt and the COVID-19 pandemic affected each of the patient-reported outcomes.
The study included 2,225 patients receiving care at one of 41 primary care practices across the United States. Of these patients, 76% were White, 12% were African American, 3% were Asian, 2% were Native Hawaiian or Pacific Islander, 1% were American Indian or Alaska Native, and 6% identified as another race or preferred not to say; 7% were Hispanic. The average age was 64, and 66% were female.
Patients and their family members, behavioral health staff, primary care clinicians, health insurers, healthcare organizations, and state and federal policy makers provided input on the study.
Results
COVID-19 burden did not have a significant impact on the IBH intervention’s effectiveness in improving patient physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, pain intensity, or pain interference.
Limitations
Researchers did not have a validated measure of COVID-19 burden; findings may have differed if they had used a validated measure.
Conclusions and Relevance
The study found no evidence that the COVID-19 pandemic had an impact on the effectiveness of the IBH intervention.
Peer Review Summary
The Peer-Review Summary for this COVID-19 study will be posted here soon.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by Sept. 2024.
Final Research Report
This project's final research report is expected to be available by September 2024.
Journal Citations
Results of This Project
Related Journal Citations
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:
- The reviewers requested more information on how the researchers monitored treatment fidelity given that they allowed sites to skip some steps or strategies in the intervention toolkit. The researchers explained that although they did obtain some information on toolkit completion for administrative purposes, analysis of treatment fidelity was beyond the scope of this study. Further, the researchers noted that the pragmatic nature of this study precluded their ability to assess whether study participants who received all elements of the toolkit fared better than participants who did not.
- The reviewers questioned the approach the researchers took to assess the effect of missing data and whether the lack of significant differences between treatment groups could be the result of missing outcomes for a number of study participants. The researchers countered that their lost-to-follow-up rate was quite low given the pragmatic nature of the study, and that their approach to analyzing the effects of missing data did not indicate that this was a cause for the lack of difference between treatment groups.
- The reviewers asked the researchers to expand on the lessons learned and next steps for this research area, particularly related to the usefulness of integrated behavioral health (IBH). The researchers clarified that there is considerable evidence supporting IBH care despite the limited impact of their toolkit on the integration of this model into a range of clinical settings. Different study designs or focus on specific elements of the toolkit might provide more robust results.