Which is more effective, an integrated or referral approach to using clinic-to-clinic interactive video to deliver evidence-based mental health treatments to patients with complex psychiatric disorders in primary care clinics?
In this pragmatic randomized comparative effectiveness trial including 1004 adult participants, both approaches significantly and substantially improved clinical outcomes. The referral approach used substantially more mental health specialist time than the integrated approach.
Based on findings from this trial, from a health care system perspective, clinical leadership should implement whichever approach is most sustainable; from a societal perspective, policy makers should incentivize the integrated approach because it required less scarce mental health specialist time.
Only one-third of patients with complex psychiatric disorders engage in specialty mental health care, and only one-tenth receive adequate treatment in primary care. Scalable approaches are critically needed to improve access to effective mental health treatments in underserved primary care settings.
To compare 2 clinic-to-clinic interactive video approaches to delivering evidence-based mental health treatments to patients in primary care clinics.
Design, Setting, and Participants
This pragmatic comparative effectiveness trial used a sequential, multiple-assignment, randomized trial (SMART) design with patient-level randomization. Adult patients treated at 24 primary care clinics without on-site psychiatrists or psychologists from 12 federally qualified health centers in 3 states who screened positive for posttraumatic stress disorder and/or bipolar disorder and who were not already receiving pharmacotherapy from a mental health specialist were recruited from November 16, 2016, to June 30, 2019, and observed for 12 months.
Two approaches were compared: (1) telepsychiatry/telepsychology–enhanced referral (TER), where telepsychiatrists and telepsychologists assumed responsibility for treatment, and (2) telepsychiatry collaborative care (TCC), where telepsychiatrists provided consultation to the primary care team. TER included an adaptive intervention (phone-enhanced referral [PER]) for patients not engaging in treatment, which involved telephone outreach and motivational interviewing.
Main Outcomes and Measures
Survey questions assessed patient-reported outcomes. The Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score was the primary outcome (range, 0-100). Secondary outcomes included posttraumatic stress disorder symptoms, manic symptoms, depressive symptoms, anxiety symptoms, recovery, and adverse effects.
Of 1004 included participants, 701 of 1000 (70.1%) were female, 660 of 994 (66.4%) were White, and the mean (SD) age was 39.4 (12.9) years. Baseline MCS scores were 3 SDs below the US mean; the mean (SD) MCS scores were 39.7 (14.1) and 41.2 (14.2) in the TCC and TER groups, respectively. There was no significant difference in 12-month MCS score between those receiving TCC and TER (β = 1.7; 95% CI, 0 to 3.4; P = .05). Patients in both groups experienced large and clinically meaningful improvements from baseline to 12 months (TCC: Cohen d = 0.79; 95% CI, 0.65 to 0.94; TER: Cohen d = 0.87; 95% CI, 0.73 to 1.02). For patients not engaging in TER at 6 months, there was no significant difference in 12-month MCS score between those receiving PER and TER (β = 2.0; 95% CI, −1.6 to 5.7; P = .28).
Conclusions and Relevance
In this comparative effectiveness trial of patients with complex psychiatric disorders randomized to receive TCC or TER, significantly and substantially improved outcomes were observed in both groups. From a health care system perspective, clinical leadership should implement whichever approach is most sustainable.
ClinicalTrials.gov Identifier: NCT02738944
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: June 29, 2021.
Published Online: August 25, 2021. doi:10.1001/jamapsychiatry.2021.2318
Correction: This article was corrected on August 23, 2023, to fix errors in Figure 2 and on May 3, 2023, to fix errors in the abstract, text, Table 2, Figure 3, eTable, and visual abstract caused by mistakenly using the wrong subscale of the Veterans RAND 12-item Healthy Survey.
Corresponding Author: John C. Fortney, PhD, Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, 1959 NE Pacific St, Box 356560, Seattle, WA 98195 (email@example.com).
Author Contributions: Drs Fortney and Hawrilenko had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Fortney, Bauer, Cerimele, Pyne, Heagerty, Kaysen, Bowen, Moore, Metzger, Hafer, Unützer.
Acquisition, analysis, or interpretation of data: Fortney, Bauer, Cerimele, Pyne, Pfeiffer, Heagerty, Hawrilenko, Zielinski, Kaysen, Bowen, Moore, Ferro, Shushan, Nolan, Dalack, Unützer.
Drafting of the manuscript: Fortney, Hawrilenko, Bowen, Moore, Metzger, Hafer.
Critical revision of the manuscript for important intellectual content: Bauer, Cerimele, Pyne, Pfeiffer, Heagerty, Hawrilenko, Zielinski, Kaysen, Moore, Ferro, Shushan, Nolan, Dalack, Unützer.
Statistical analysis: Fortney, Heagerty, Hawrilenko.
Obtained funding: Fortney, Kaysen, Hafer.
Administrative, technical, or material support: Fortney, Bauer, Pfeiffer, Zielinski, Kaysen, Bowen, Moore, Ferro, Metzger, Shushan, Hafer, Nolan, Dalack, Unützer.
Study supervision: Fortney, Pyne, Kaysen, Unützer.
Conflict of Interest Disclosures: Drs Fortney, Bauer, Cerimele, Heagerty, Kaysen, Shushan, and Dalack have received grants from the Patient-Centered Outcomes Research Institute during the conduct of the study. Dr Bauer has received grants from the National Institutes of Health, Washington State Legislature Integrated Care Training Program, and Premera Blue Cross Rural Mental Health Integration Initiative outside the submitted work. Dr Pyne has received grants from the University of Arkansas for Medical Sciences during the conduct of the study. Dr Kaysen has received personal fees from Elsevier Publishing and honorarium for conducting trainings or workshops in cognitive processing therapy outside the submitted work. Dr Moore has received support from the University of Washington during the conduct of the study. No other disclosures were reported.
Funding/Support: This work was supported by a grant PCS-1406-19295 from the Patient-Centered Outcomes Research Institute to Drs Fortney and Unützer.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its board of governors, or methodology committee.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the patients and staff of Family Health Centers, Omak, Washington; Moses Lake Community Health Center, Moses Lake, Washington; Sea Mar Community Health Centers, Seattle, Washington; Yakima Neighborhood Health Services, Yakima, Washington; Boston Mountain Rural Health Centers, Marshal, Arkansas; East Arkansas Family Health Center, West Memphis; Lee County Cooperative Clinic, Marianna, Arkansas; Cherry Health, Grand Rapids, Michigan; Family Medical Center, Temperance, Michigan; Great Lakes Bay Health Centers, Saginaw, Michigan; InterCare Community Health Network, Bangor, Michigan; and Upper Great Lakes Family Health Center, Calumet, Michigan. We thank the staff of the Community Health Plan of Washington, the Community Health Centers of Arkansas, and the Michigan Primary Care Association. We thank our policy advisory board: Donald Weaver, MD (National Association of Community Health Centers, Bethesda, Maryland); Ed Larkins, MHA (Family Medical Center); Jay Shore, MD (University of Colorado at Denver); LaShannon Spencer, MPA, MHSA (Community Health Centers of Arkansas, Little Rock); Nancy Speck, PhD (National Association for Rural Mental Health, Houston, Texas); Sara Coates, MA, MPH, and Dawne Velianoff, LMSW (Michigan Primary Care Association, Lansing); and Susan Ward-Jones, MD (East Arkansas Family Health Center). We thank our consumer advisor board: Bernadette McDonald, BS; Florence Fee, JD (No Health Without Mental Health, Arlington, Virginia); Ingrid Deetz, BS, Kevin Einbinder, BS, and Betsy O’Brien, BS (Depression and Bipolar Support Alliance, Chicago, Illinois); Kim Arnold, BS, Marquitta Magnini, BS, and Shawn McCown, BS (National Alliance on Mental Illness, Little Rock, Arkansas); Jode Freyholtz-London, AAS (Wellness in the Woods, Eagle Bend, Minnesota); and Tammy Heral and Jeremy Mullins. We thank the members of our external data safety monitoring board: Thomas Belin, PhD (University of California, Los Angeles); John Williams, MD (Duke University, Durham, North Carolina); and Mark Williams, MD (Mayo Clinic, Rochester, Minnesota). Also, thanks to our research staff Suzanne Hunter, BS, Jared Bechtel, BS, Diane Powers, MA, MBA, Shiyu Chen, MS, and Morgan Johnson, MS (Department of Psychiatry, University of Washington, Seattle); and Nick Ponomarev, PhD, and Dan Vakoch, MS (Social and Economic Sciences Research Center, Washington State University, Pullman). We thank the following electronic health record vendors for giving us substantial discounts on the user licenses for the telepsychiatrists and telepsychologists: NextGen Healthcare, eClinicalWorks, Centricity (GE Healthcare), Allscripts, and SuccessEHS, Inc. Members of the policy advisory board and consumer advisory board as well as our research staff were compensated for their work. Lastly, we thank Morgan Johnson, MS (Department of Psychiatry, University of Washington, Seattle), and Brittany Blanchard, PhD (Department of Psychiatry, University of Washington), for finding an error in the originally published Mental Component Summary results and rerunning the statistical analyses reported in the correction.
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