Study to Promote Innovation in Rural Integrated Telepsychiatry

NCT02738944 | Completed DMC

• 1 other identifier: STUDY00001069
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 13

Brief Summary

Background: Community Health Centers care for over 20 million rural, low income and minority Americans every year. Patients often have complex mental health problems such as Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers located in rural areas face substantial challenges to managing these patients due to lack of onsite mental health specialists, stigma and poor geographic access to specialty mental health services in the community. As a consequence, many rural primary care providers feel obligated, yet unprepared, to manage these disorders, and many patients receive inadequate treatment and continue to struggle with their symptoms. While integrated care models and telepsychiatry referral models are both promising approaches to managing patients with complex mental health problems in rural primary care settings, there have been no studies comparing which approach is more effective for which types of patients. Objectives: The central question examined by this study is whether it is better for offsite mental health specialists to support primary care providers' treatment of patients with PTSD and Bipolar Disorder through an integrated care model or to use telemedicine technology to facilitate referrals to offsite mental health specialists. We hypothesize that patients randomized to integrated care will have better outcomes than patients randomized to referral care. Methods: 1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited from Community Health Centers in three states (Arkansas, Michigan and Washington) and randomized to the integrated care model or the referral model. Patient Outcomes: Telephone surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups. Telephone surveys will measure access to care, therapeutic alliance with providers, patient-centeredness, patient activation, satisfaction with care, appointment attendance, medication adherence, self-reported clinical symptoms, medication side-effects, health related quality of life, and progress towards life goals. A sub-sample of patients will be invited to participate in qualitative interviews to describe their treatment experience using their own words. Likewise, primary care providers will be invited to participate in qualitative interviews to voice their perspective.

Conditions

Bipolar Disorder; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Mental Health Related Quality of Life

  Short Form 12 Mental Health Composite Summary (MCS)

  12 month follow-up

Secondary Outcomes (8)

• Recovery-oriented outcomes

  12 month follow-up

• Psychotherapy engagement

  Between baseline and 12 month follow-up

• Medication Adherence

  12 month follow-up

• Satisfaction

  12 month follow-up

• Depression Severity

  12 month follow-up

Other Outcomes (19)

• Perceived access to mental health services

  6 month follow-up

• Perceived access to mental health services

  12 month follow-up

• Beliefs About Mental Health Treatment

  6 month follow-up

Study Arms (2)

Integrated Care

ACTIVE COMPARATOR

Telepsychiatry Collaborative Care

Behavioral: Telepsychiatry Collaborative Care

Referral Care

ACTIVE COMPARATOR

Telepsychiatry Enhanced Referral

Behavioral: Telepsychiatry Enhanced Referral

Interventions

Telepsychiatry Collaborative Care BEHAVIORAL

The telepsychiatrist will also conduct an initial consultation with the patient via interactive video to establish the diagnosis and recommend medications to prescribe. Onsite primary care providers prescribe psychotropic medications. Onsite care managers work with patients either face-to-face or by phone to promote adherence to treatment and assess treatment response. Care managers provide Behavioral Activation either face-to-face or by phone. Care managers have weekly provider-to-provider consultations with the telepsychiatrist to review treatment plans for patients not responding to treatment. The telepsychiatrist will make revised treatment recommendations to the primary care provider.

Integrated Care

Telepsychiatry Enhanced Referral BEHAVIORAL

The offsite telepsychiatrist and/or telepsychologist delivers the treatment via interactive video to patients located at primary care clinics. Telepsychiatrists/telepsychologists administer symptom rating scales at each session. The first encounter will be with the telepsychiatrist to establish diagnosis and develop a treatment plan consisting of algorithm-informed medication management and/or evidence-based psychotherapy. The telepsychiatrists will prescribe medications. Psychotherapy options include Cognitive Processing Therapy and Cognitive Behavioral Therapy. If a patient does not engage in treatment (\<=2 encounters) in the first six months, they will be randomized a second time to continued Telepsychiatry Enhanced Referral or Telephone Enhanced Referral for the second six months. Phone Enhanced Referral involves delivering psychiatric and/or psychological treatment (either initially or exclusively) by telephone to patients in their home.

Referral Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled as a patient at a participating Federally Qualified Health Center
• Screen positive for Bipolar Disorder on the Composite International Diagnostic Interview (CIDI) AND/OR screen positive for PTSD on the PTSD Check List (PCL)-6

You may not qualify if:

• Currently prescribed a psychotropic medication by a mental health specialist.
• Lacks capacity to provide informed consent
• Does not speak English or Spanish

Sponsors & Collaborators

• University of Washington: lead
• University of Arkansas: collaborator
• University of Michigan: collaborator
• Oregon Health and Science University: collaborator
• Washington State University: collaborator
• HealthPartners Institute: collaborator
• Kaiser Permanente: collaborator
• Community Health Centers of Arkansas: collaborator
• Michigan Primary Care Association: collaborator
• Community Health Plan of Washington: collaborator

Study Sites (13)

Lee County Cooperative Clinic

Marianna, Arkansas, 72301, United States

Location

Boston Mountain Rural Health Centers

Marshall, Arkansas, 72650, United States

Location

East Arkansas Family Health Center

West Memphis, Arkansas, 72301, United States

Location

InterCare Community Health Network

Bangor, Michigan, 49013, United States

Location

Cherry Health

Grand Rapids, Michigan, 49503, United States

Location

Upper Great Lakes Family Health Center

Gwinn, Michigan, 49841, United States

Location

Family Health Center

Kalamazoo, Michigan, 49007, United States

Location

Health Delivery, Inc

Saginaw, Michigan, 48607, United States

Location

Family Medical Center of Michigan

Temperance, Michigan, 48182, United States

Location

Moses Lake Community Health Center

Moses Lake, Washington, 98837, United States

Location

Family Health Centers

Okanogan, Washington, 98840, United States

Location

Sea Mar Community Health Center

Seattle, Washington, 98108, United States

Location

Yakima Neighborhood Health Services

Yakima, Washington, 98907, United States

Location

Related Publications (4)

• Severe J, Pfeiffer PN, Palm-Cruz K, Hoeft T, Sripada R, Hawrilenko M, Chen S, Fortney J. Clinical Predictors of Engagement in Teleintegrated Care and Telereferral Care for Complex Psychiatric Disorders in Primary Care: a Randomized Trial. J Gen Intern Med. 2022 Oct;37(13):3361-3367. doi: 10.1007/s11606-021-07343-x. Epub 2022 Feb 2.

  PMID: 35106719 DERIVED

• Fortney JC, Bauer AM, Cerimele JM, Pyne JM, Pfeiffer P, Heagerty PJ, Hawrilenko M, Zielinski MJ, Kaysen D, Bowen DJ, Moore DL, Ferro L, Metzger K, Shushan S, Hafer E, Nolan JP, Dalack GW, Unutzer J. Comparison of Teleintegrated Care and Telereferral Care for Treating Complex Psychiatric Disorders in Primary Care: A Pragmatic Randomized Comparative Effectiveness Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1189-1199. doi: 10.1001/jamapsychiatry.2021.2318.

  PMID: 34431972 DERIVED

• Fortney JC, Pyne JM, Hawrilenko M, Bechtel JM, Moore D, Nolan JP, Pfeiffer P, Shushan S, Shore JH, Bowen D. Psychometric Properties of the Assessment of Perceived Access to Care (APAC) Instrument. J Ambul Care Manage. 2021 Jan/Mar;44(1):31-45. doi: 10.1097/JAC.0000000000000358.

  PMID: 33165120 DERIVED

• Bauer AM, Jakupcak M, Hawrilenko M, Bechtel J, Arao R, Fortney JC. Outcomes of a health informatics technology-supported behavioral activation training for care managers in a collaborative care program. Fam Syst Health. 2021 Mar;39(1):89-100. doi: 10.1037/fsh0000523. Epub 2020 Aug 27.

  PMID: 32853001 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• John Fortney, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (13)