Project Summary
PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
More than 20 million Americans get care at community health centers every year. Almost half of these people live in rural areas. Community health centers often see patients with complex mental health conditions. These include post-traumatic stress disorder (PTSD) and bipolar disorder. These conditions need treatment from a health professional with special training in mental health care. Patients who do not receive adequate treatment for PTSD or bipolar disorder may have serious physical and emotional consequences. Primary care providers in community health centers—such as doctors, physician assistants, and nurse practitioners—may not have training to treat these conditions. Not enough mental health doctors live in rural areas to treat these health conditions there.
One way to address these challenges is through telemedicine. Telemedicine involves doctors using technology, such as videoconferencing, to treat patients remotely. This study compares two telemedicine options, called telepsychiatry-collaborative care and telepsychiatry-enhanced referral, for patients with PTSD and bipolar disorder at rural community health centers.
Who can this research help?
This research can help rural community health centers make decisions about how to provide mental health services to patients with PTSD or bipolar disorder.
What is the research team doing?
The study is taking place at 15 rural community health centers in Arkansas, Michigan, and Washington. The research team is enrolling 1,000 people. This includes 500 people who have PTSD and 500 people who have bipolar disorder, according to screening tests. The patients aren’t getting treatment from a mental health doctor when they join the study. The team is assigning patients by chance to rteceive either telepsychiatry-collaborative care or telepsychiatry-enhanced referral.
Each patient in the collaborative-care group first has a one-on-one video appointment with a mental health doctor. The doctor confirms the patient’s diagnosis and recommends medicines for treatment. A primary care provider then carries out the treatment plan and writes prescriptions for medicine. A care manager at the community center meets regularly in person or by phone with the patient to provide behavioral therapy. The care manager makes sure the patient takes medicines correctly and that the treatment is working. The care manager talks to the mental health doctor each week about any patient whose condition is not responding to treatment. The mental health doctor can then recommend a different treatment.
Each patient in the enhanced referral group also first has a one-on-one video appointment with a mental health doctor to come up with a treatment plan. This plan can include medicines and/or counseling. A patient who gets counseling has regular video appointments at the community health center with a mental health doctor.
All patients take surveys by phone when they begin the study. They take another survey after 6 and 12 months. The surveys ask patients about topics related to their care, health condition, and quality of life. The research team interviews the primary care providers to learn about their experiences giving treatment. They also interview some of the patients to learn about their experiences getting treatment.
The research team came up with this research topic by talking to patients and healthcare professionals who took part in previous studies. Two advisory groups are helping design the treatment approaches and study methods. The consumer advisory board includes patients with PTSD and bipolar disorder. It also includes members of patient advocacy groups. The policy advisory board includes primary care providers at community health centers and members of professional associations.
Research methods at a glance
| Design Element | Description |
|---|---|
| Study Design | Randomized controlled trial |
| Population | Patients at community health centers who are 18 years or older, screen positive for PTSD and/or bipolar disorder, and are not currently taking medicines for their condition(s) |
| Interventions/ Comparators |
|
| Outcomes |
Primary: self-rating of mental health-related quality of life Secondary: satisfaction and engagement with care, medication adherence, number of counseling sessions that participant attended illness severity |
 |
12-month follow-up for primary outcome |
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