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Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT)

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ClinicalTrials.gov Identifier: NCT02738944
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : November 30, 2017
Sponsor:
Collaborators:
University of Arkansas
University of Michigan
Oregon Health and Science University
Washington State University
HealthPartners Institute
Kaiser Permanente
Community Health Centers of Arkansas
Michigan Primary Care Association
Community Health Plan of Washington
Information provided by (Responsible Party):
John Fortney, University of Washington

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Posttraumatic Stress Disorder Behavioral: Telepsychiatry Collaborative Care Behavioral: Telepsychiatry Enhanced Referral Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated vs. Referral Care for Complex Psychiatric Disorders in Rural FQHCs
Study Start Date : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Integrated Care
Telepsychiatry Collaborative Care
Behavioral: Telepsychiatry Collaborative Care
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.

Active Comparator: Referral Care
Telepsychiatry Enhanced Referral
Behavioral: Telepsychiatry Enhanced Referral

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.





Primary Outcome Measures :
  1. Mental Health Related Quality of Life [ Time Frame: 12 month follow-up ]
    Short Form 12 Mental Health Composite Summary (MCS)


Secondary Outcome Measures :
  1. Recovery-oriented outcomes [ Time Frame: 12 month follow-up ]
    Recovery Assessment Scale

  2. Psychotherapy engagement [ Time Frame: Between baseline and 12 month follow-up ]
    Number of self-reported Cognitive Behavioral Therapy, Cognitive Processing Therapy, or Behavioral Activation counseling sessions that were attended

  3. Medication Adherence [ Time Frame: 12 month follow-up ]
    Scale reported in Miklowitz et cal. Psychopharmacol Bull 1986

  4. Satisfaction [ Time Frame: 12 month follow-up ]
    Experience of Care and Health Outcomes Survey (satisfaction question)

  5. Depression Severity [ Time Frame: 12 month follow-up ]
    Hopkins Symptom Check List (SCL)-20

  6. Mania Severity (for sub-sample screening positive for Bipolar Disorder) [ Time Frame: 12 month follow-up ]
    Altman Mania Rating Scale (modified by the investigators for telephone delivery)

  7. Bipolar Severity (for sub-sampling screening positive for Bipolar Disorder) [ Time Frame: 12 month follow-up ]
    Internal State Scale, Version 2

  8. PTSD Severity (for sub-sampling screening positive for PTSD) [ Time Frame: 12 month follow-up ]
    PTSD Check List (PCL-5)


Other Outcome Measures:
  1. Perceived access to mental health services [ Time Frame: 6 month follow-up ]
    SPIRIT Perceived Access Inventory (new)

  2. Perceived access to mental health services [ Time Frame: 12 month follow-up ]
    SPIRIT Perceived Access Inventory (new)

  3. Beliefs About Mental Health Treatment [ Time Frame: 6 month follow-up ]
    Endorsed and Anticipated Stigma Inventory (EASI)

  4. Beliefs About Mental Health Treatment [ Time Frame: 12 month follow-up ]
    Endorsed and Anticipated Stigma Inventory (EASI)

  5. Therapeutic Alliance [ Time Frame: 6 month follow-up ]
    Kim Alliance Scale

  6. Therapeutic Alliance [ Time Frame: 12 month follow-up ]
    Kim Alliance Scale

  7. Patient activation [ Time Frame: 6 month follow-up ]
    SPIRIT Mental Health Activation (new)

  8. Patient activation [ Time Frame: 12 month follow-up ]
    SPIRIT Mental Health Activation (new)

  9. Use of health services [ Time Frame: Between baseline and 12 month follow-up ]
    survey questions written for the study

  10. Patient Centeredness [ Time Frame: 6 month follow-up ]
    Patient Assessment of Care for Chronic Conditions

  11. Patient Centeredness [ Time Frame: 12 month follow-up ]
    Patient Assessment of Care for Chronic Conditions

  12. Psychotropic medication side effects [ Time Frame: 6 month follow-up ]
    Total number of side effects rated as moderate to severe by the study participant

  13. Psychotropic medication side effects [ Time Frame: 12 month follow-up ]
    Total number of side effects rated as moderate to severe by the study participant

  14. Alcohol misuse [ Time Frame: 6 month follow-up ]
    Audit-C

  15. Alcohol misuse [ Time Frame: 12 month follow-up ]
    Audit-C

  16. Sleep [ Time Frame: 6 month follow-up ]
    Pittsburgh Sleep Quality Index (PSQI)

  17. Sleep [ Time Frame: 12 month follow-up ]
    Pittsburgh Sleep Quality Index (PSQI)

  18. Generalized Anxiety Disorder [ Time Frame: 6 month follow-up ]
    GAD-7

  19. Generalized Anxiety Disorder [ Time Frame: 12 month follow-up ]
    GAD-7



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738944


Contacts
Contact: John Fortney, PhD 206-685-6955 fortneyj@uw.edu
Contact: Lori Ferro, MPA 206-221-8523 ljf9@uw.edu

Locations
United States, Arkansas
Lee County Cooperative Clinic Recruiting
Marianna, Arkansas, United States, 72301
Contact: Clifton Collier    870-295-5225    clifcol39@aol.com   
Boston Mountain Rural Health Centers Recruiting
Marshall, Arkansas, United States, 72650
Contact: Betty Sanders    870-448-5733    bettysanders@bmrhc.net   
East Arkansas Family Health Center Recruiting
West Memphis, Arkansas, United States, 72301
Contact: Susan Ward-Jones    870-735-3842    swjones@eafhc.org   
United States, Michigan
InterCare Community Health Network Recruiting
Bangor, Michigan, United States, 49013
Contact: Velma Hendershot    269-427-7937    velma@intercare.org   
Cherry Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Chris Shea    616-965-8200    ChrisShea@cherryhealth.com   
Upper Great Lakes Family Health Center Recruiting
Gwinn, Michigan, United States, 49841
Contact: Donald Similia    906-483-1325    Donald.Simila@UGLHealth.org   
Family Health Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Mary Hoekstra    269-349-2641    mary.hoekstra@fhckzoo.com   
Health Delivery, Inc Recruiting
Saginaw, Michigan, United States, 48607
Contact: Brenda Coughlin    989-753-6000    bcoughlin@healthdelivery.org   
Family Medical Center of Michigan Recruiting
Temperance, Michigan, United States, 48182
Contact: Ed Larkins    734-847-3802    elarkins@familymedical.org   
United States, Washington
Moses Lake Community Health Center Recruiting
Moses Lake, Washington, United States, 98837
Contact: Shelia Chilson    509-765-0674    sberschauer@mlchc.org   
Family Health Centers Recruiting
Okanogan, Washington, United States, 98840
Contact: Heather Findlay    509-422-7629    hfindlay@myfamilyhealth.org   
Sea Mar Community Health Center Recruiting
Seattle, Washington, United States, 98108
Contact: Rogelio Riojas    206-763-5277    rogelioriojas@seamarchc.org   
Yakima Neighborhood Health Services Recruiting
Yakima, Washington, United States, 98907
Contact: Anita Monoian    509-454-4143    Anita.Monoian@ynhs.org   
Sponsors and Collaborators
University of Washington
University of Arkansas
University of Michigan
Oregon Health and Science University
Washington State University
HealthPartners Institute
Kaiser Permanente
Community Health Centers of Arkansas
Michigan Primary Care Association
Community Health Plan of Washington
Investigators
Principal Investigator: John Fortney, PhD University of Washington

Responsible Party: John Fortney, Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT02738944     History of Changes
Other Study ID Numbers: STUDY00001069
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If requested by the funding agency (the Patient Centered Outcomes Research Institute), a complete, cleaned and de-identified copy of the final quantitative dataset used to test the stated hypotheses will be made available to other researchers within one year of the study completion date. The final data set will include de-identified demographic and clinical data obtained from the telephone survey for all patients participating in the comparative effectiveness trial. Along with the data set, we will create a code book documenting all variables (e.g., common names for single questionnaire items, and scoring algorithms for derived variables).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Stress Disorders, Post-Traumatic
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders