What was the research about?
Federally Qualified Health Centers, or FQHCs, are community clinics that provide primary care in rural and other underserved areas. FQHCs often don’t have enough mental health specialists to treat patients with complex mental health conditions, such as patients with both posttraumatic stress disorder, or PTSD, and bipolar disorder.
In this study, the research team compared two telehealth approaches for patients with complex mental health conditions who received care at rural clinics. Telehealth is a way to provide care to patients remotely using phone or video calls. The two approaches were:
- Telepsychiatry collaborative care, or TCC. In TCC, patients met with care managers in person or by phone. Care managers taught patients about their mental health, checked their symptoms, and provided therapy. Care managers also had weekly meetings with off-site mental health doctors to review and adjust patients’ treatment plans. Primary care doctors prescribed all medicines for mental health.
- Telepsychiatry-enhanced referral, or TER. In TER, patients had video calls at their clinic with an off-site therapist or mental health doctor. Remote therapists provided therapy. Remote doctors prescribed medicine to patients who needed it. TER required more time from therapists and mental health doctors than TCC.
In both approaches, patients first had a video call with a mental health doctor to develop a treatment plan.
What were the results?
After one year, patients in both TCC and TER reported that their quality of life, mental health symptoms, and side effects had greatly improved. Patients in TCC and TER didn’t differ in reports of:
- Quality of life
- Severity of mental health symptoms
- Satisfaction with care
- Access to care
- Medicine side effects
Patients also didn’t differ in sticking with their mental health medicines.
Who was in the study?
The study included 1,004 adults who had symptoms of PTSD, bipolar disorder, or both. Only patients who weren’t taking medicines prescribed by a mental health doctor took part in the study.
Among patients, 66 percent were White, 13 percent were Black, and 21 percent identified as another race or ethnicity. The average patient age was 39, and 70 percent were women. All received care at one of 24 clinics from12 FQHCs. The clinics were in underserved areas in Arkansas, Michigan, and Washington.
What did the research team do?
The research team assigned patients by chance to either TCC or TER.
Patients completed surveys at the start of the study and again one year later. Surveys asked about quality of life, their care, and their mental health.
Patients, patient advocates, mental health providers, and health insurers provided input during the study.
What were the limits of the study?
Fewer patients took the follow-up surveys than planned. Results may have differed if more patients had completed the surveys.
Future research could look at what clinics need in order to provide these programs to patients.
How can people use the results?
FQHCs and other clinics can use the results when considering ways to offer mental health care for patients with complex mental health conditions.
To compare the effectiveness of two clinic-to-clinic interactive video approaches for delivering mental health treatment on improving quality of life among patients with complex psychiatric conditions who received care in primary care clinics
|Study Design||Randomized controlled trial|
|Population||1,004 adult patients who had screened positive for depression as well as PTSD, bipolar disorder, or both and who were receiving primary care at FQHCs located in rural and underserved areas|
Primary: health-related quality of life
Secondary: symptom severity, satisfaction with care, perceived access to care, medication adherence, number of counseling sessions that participant attended, side effects
|Timeframe||1-year follow-up for primary outcome|
In this pragmatic randomized trial, the research team compared the effectiveness of two approaches to telepsychiatry on improving quality of life among patients with complex psychiatric disorders who received care at primary care clinics. The team identified adult patients who had screened positive for depression and enrolled those who had also screened positive for posttraumatic stress disorder (PTSD), bipolar disorder, or both.
The research team randomly assigned patients to one of two groups, TCC or TER:
- In TCC, care managers and consulting telepsychiatrists supported the primary care provider. A care manager met with patients in person or by phone at each clinic. Care managers provided patients with mental health education, monitored patients’ symptoms and treatment adherence, and provided psychotherapy. They reviewed and adjusted patients’ treatment plans during weekly consultations with an off-site psychiatrist. Care managers also coordinated care with the patients’ primary care providers, who prescribed all psychiatric medications.
- In TER, telepsychiatrists and telepsychologists assumed responsibility for treatment. An off-site psychiatrist or psychologist provided assessments, medication management, and psychotherapy via video calls to patients who were at the clinic.
In both groups, patients first had a video call with a mental health specialist to develop a treatment plan. TCC relied on substantially less mental health provider time than TER.
The study included 1,004 adult patients. Of the patients, 66% were White, 13% were Black, and 21% identified as another race or ethnicity. The average patient age was 39, and 70% were female. Patients received care at one of 24 clinics that had no on-site psychiatrists or psychologists in rural areas of Arkansas, Michigan, and Washington. The clinics were associated with 12 Federally Qualified Health Centers (FQHCs).
At baseline and again at 6 and 12 months, patients completed surveys on primary and secondary outcomes.
Patients, patient advocates, healthcare providers, and health insurers helped to design and conduct the study.
At 12 months, patients in the two groups did not differ significantly on health-related quality of life. Patients in both groups experienced large and clinically meaningful improvements from baseline to 12 months (Cohen’s dTCC=0.81; 95% confidence interval [CI]: 0.67, 0.95; Cohen’s dTER=0.90; 95% [CI]: 0.76, 1.04).
Patients in the two groups did not differ significantly in any secondary outcomes. Patients in both groups experienced significant and clinically meaningful improvements in symptoms and side effects.
Survey follow-up rates were relatively low at 64% of the baseline sample at 12 months, but differences between survey completers and noncompleters were not significant.
Conclusions and Relevance
In this study, TCC and TER showed similar substantial and statistically significant improvements in patients’ quality of life and symptoms. TCC required one-third as many telepsychiatry encounters as TER.
Future Research Needs
Future research could examine approaches to support adoption of effective telepsychiatry approaches at FQHCs.
Final Research Report
View this project's final research report.
Related Journal Citations
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 noted that there was some confusion about the group comparisons as a result of the second round of randomization only for participants in the Telepsychiatry/Telepsychology Enhanced Referral (TER) group if they had not engaged in the available intervention. These participants were randomized at six months to either continue in the TER group or enter a Phone Enhanced Referral group for the next six months. The researchers clarified that they included all participants who entered the TER group at baseline, regardless of their intervention group at 12 months, in the main comparison of TER against Telepsychiatry Collaborative Care.
- Reviewers asked the researchers to expand their explanation about the data that were imputed to account for missing information, especially if the variables that that were imputed included outcome variables. The researchers explained that they imputed all variables with missing data and provided articles justifying this approach as reducing bias and improving the precision of study findings.
- Reviewers felt that the study would have been strengthened by the addition of a usual care comparison group. The researchers admitted that journal reviewers also felt that was a limitation of the study. However, the researchers pointed out this study was specifically funded as a comparative effectiveness trial of the two telehealth interventions which have already been proven to be better than usual care; therefore the absence of a usual care comparison group should not be considered a limitation in this report.
Study Registration Information
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