Study to Promote Innovation in Rural Integrated Telepsychiatry

Bipolar Disorder Clinical Trial

— SPIRIT  

Official title:

Integrated vs. Referral Care for Complex Psychiatric Disorders in Rural FQHCs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738944
• Other study ID #: STUDY00001069
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background and Significance: Community Health Centers (CHCs) are the nation's largest and fastest growing network of primary care (PC) clinics. There are 1,200 CHCs that provide clinical services to 21 million Americans. Almost half (49%) of CHC patients live in rural areas, 72% live at or below the Federal Poverty Level (100%), 67% are racial/ethnic minorities, and 36% are uninsured. Nationally, over one million CHC patients are diagnosed with a psychiatric disorder and the need for mental health (MH) services is increasing exponentially, with a 547% increase in CHC patients with a psychiatric diagnosis between 2001 and 2012. CHCs located in rural areas face the greatest challenges to managing psychiatric disorders due to the lack of MH specialists on staff and weak linkages between CHCs and MH specialists in the community. Because rural, minority, low income CHC patients face insurmountable geographical, cultural and financial barriers to specialty MH care, many of their PC providers feel obligated, yet unprepared, to manage complex psychiatric disorders like posttraumatic stress disorder (PTSD) and Bipolar Disorder (BD). PTSD and BD are devastating psychiatric disorders that often go undetected and untreated in PC. Most patients do not receive effective specialty MH care for these problems and the care provided in PC settings is often poor and ineffective. Patients with PTSD and BD have significantly worse educational attainment, lower family, social, and occupational functioning, and significantly lower quality of life. Comparative effectiveness research is needed to guide policy makers about how to best manage the growing demand for MH services in CHCs.

Study Aims: The central question addressed by this mixed-methods pragmatic comparative effectiveness trial is whether it is better to expand the scope of collaborative care programs to treat patients with more complex psychiatric disorders or to facilitate successful referrals to specialty mental health care. The primary objective of this trial is to compare Telepsychiatry Collaborative Care (TCC) and Telepsychiatry Enhanced Referral (TER) from the patient and provider perspective. The secondary objective is to determine whether patients not engaging to TER, improve with Phone-Psychiatry Enhanced Referral (PER). There are four specific aims. Specific Aim #1: To quantitatively compare the treatment experience, engagement, self-reported clinical outcomes, and recovery-oriented outcomes of patients initially randomized to TCC and TER. Specific Aim #2: For the subset of patients randomized to TER who do not engage in treatment and are still symptomatic at 6 months, quantitatively compare treatment experience, treatment engagement, self-reported clinical outcomes and recovery-oriented outcomes of patients randomized to continued-TER or PER. Specific Aim #3: To gain an in-depth understanding of patients' and providers' treatment experience, qualitatively compare those randomized to TCC, TER and PER. Specific Aim #4: To examine treatment heterogeneity among subgroups of patients randomized to TCC and TER based on race/ethnicity, age and clinical severity.

Study Description: The study will be conducted in 15 CHC systems located in the states of Arkansas, Michigan and Washington. These 15 CHC treat 294,645 adult patients living in rural areas; 96.1% live in poverty and 53% are racial/ethnic minorities. Participating clinics will screen patients for PTSD and BD and patients screening positive will be recruited. We will enroll 1,000 patients (500 with PTSD and 500 with BD). A Sequential, Multiple Assignment, Randomized Trial (SMART) design will be used to compare TCC and TER, and to determine whether patients not engaging to TER improve with PER. Specifically, patients not engaging to TER by six months will be randomized a second time to either continued-TER or PER. Patients randomized to TCC will meet with an offsite telepsychiatrist consultant via interactive video at the beginning of treatment who will assign an accurate diagnosis and provide treatment recommendations for the PC providers who will retain primary responsibility for treatment. In addition, PC providers will be supported by onsite care managers who will conduct patient outreach to foster proactive communications between an activated informed patient and a coordinated care team. Patient randomize to TER will remain in the PC setting, but receive ongoing pharmacotherapy and psychotherapy from offsite MH specialists via interactive video. Patients not engaging and responding to TER who are randomized to PER will receive ongoing treatment from offsite MH specialists via phone in the comfort of their own home. We will use a pragmatic trial design, with broad inclusion criteria (screening positive for PTSD or BD) and limited exclusion criteria (already engaged in specialty MH care). Intervention fidelity will be measured, but not controlled. Patient engagement will also be measured, but not required, and intent to treat analysis will be conducted. Patients will be the unit of randomization. Mixed quantitative and qualitative methods will be used to assess self-reported outcomes. All patients will be administered surveys at baseline, 6 and 12 months by telephone to minimize patient burden and attrition. A sub-sample of patients will be invited to participate in qualitative interviews to describe their treatment experience using their own words. Likewise, PC providers will be invited to participate in qualitative interviews to voice their perspective. The primary outcome will be patient self-reported health related quality of life. Secondary outcomes include 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, and progress towards life goals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	InterCare Community Health Network	Bangor	Michigan
United States	Cherry Health	Grand Rapids	Michigan
United States	Upper Great Lakes Family Health Center	Gwinn	Michigan
United States	Family Health Center	Kalamazoo	Michigan
United States	Lee County Cooperative Clinic	Marianna	Arkansas
United States	Boston Mountain Rural Health Centers	Marshall	Arkansas
United States	Moses Lake Community Health Center	Moses Lake	Washington
United States	Family Health Centers	Okanogan	Washington
United States	Health Delivery, Inc	Saginaw	Michigan
United States	Sea Mar Community Health Center	Seattle	Washington
United States	Family Medical Center of Michigan	Temperance	Michigan
United States	East Arkansas Family Health Center	West Memphis	Arkansas
United States	Yakima Neighborhood Health Services	Yakima	Washington

Sponsors (10)

Lead Sponsor	Collaborator
University of Washington	Community Health Centers of Arkansas, Community Health Plan of Washington, HealthPartners Institute, Kaiser Permanente, Michigan Primary Care Association, Oregon Health and Science University, University of Arkansas, University of Michigan, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived access to mental health services	SPIRIT Perceived Access Inventory (new)	6 month follow-up
Other	Perceived access to mental health services	SPIRIT Perceived Access Inventory (new)	12 month follow-up
Other	Beliefs About Mental Health Treatment	Endorsed and Anticipated Stigma Inventory (EASI)	6 month follow-up
Other	Beliefs About Mental Health Treatment	Endorsed and Anticipated Stigma Inventory (EASI)	12 month follow-up
Other	Therapeutic Alliance	Kim Alliance Scale	6 month follow-up
Other	Therapeutic Alliance	Kim Alliance Scale	12 month follow-up
Other	Patient activation	SPIRIT Mental Health Activation (new)	6 month follow-up
Other	Patient activation	SPIRIT Mental Health Activation (new)	12 month follow-up
Other	Use of health services	survey questions written for the study	Between baseline and 12 month follow-up
Other	Patient Centeredness	Patient Assessment of Care for Chronic Conditions	6 month follow-up
Other	Patient Centeredness	Patient Assessment of Care for Chronic Conditions	12 month follow-up
Other	Psychotropic medication side effects	Total number of side effects rated as moderate to severe by the study participant	6 month follow-up
Other	Psychotropic medication side effects	Total number of side effects rated as moderate to severe by the study participant	12 month follow-up
Other	Alcohol misuse	Audit-C	6 month follow-up
Other	Alcohol misuse	Audit-C	12 month follow-up
Other	Sleep	Pittsburgh Sleep Quality Index (PSQI)	6 month follow-up
Other	Sleep	Pittsburgh Sleep Quality Index (PSQI)	12 month follow-up
Other	Generalized Anxiety Disorder	GAD-7	6 month follow-up
Other	Generalized Anxiety Disorder	GAD-7	12 month follow-up
Primary	Mental Health Related Quality of Life	Short Form 12 Mental Health Composite Summary (MCS)	12 month follow-up
Secondary	Recovery-oriented outcomes	Recovery Assessment Scale	12 month follow-up
Secondary	Psychotherapy engagement	Number of self-reported Cognitive Behavioral Therapy, Cognitive Processing Therapy, or Behavioral Activation counseling sessions that were attended	Between baseline and 12 month follow-up
Secondary	Medication Adherence	Scale reported in Miklowitz et cal. Psychopharmacol Bull 1986	12 month follow-up
Secondary	Satisfaction	Experience of Care and Health Outcomes Survey (satisfaction question)	12 month follow-up
Secondary	Depression Severity	Hopkins Symptom Check List (SCL)-20	12 month follow-up
Secondary	Mania Severity (for sub-sample screening positive for Bipolar Disorder)	Altman Mania Rating Scale (modified by the investigators for telephone delivery)	12 month follow-up
Secondary	Bipolar Severity (for sub-sampling screening positive for Bipolar Disorder)	Internal State Scale, Version 2	12 month follow-up
Secondary	PTSD Severity (for sub-sampling screening positive for PTSD)	PTSD Check List (PCL-5)	12 month follow-up