Study to Promote Innovation in Rural Integrated Telepsychiatry
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/2/2017 |
| Start Date: | November 2016 |
| End Date: | June 2020 |
| Contact: | John Fortney, PhD |
| Email: | fortneyj@uw.edu |
| Phone: | 206-685-6955 |
Integrated vs. Referral Care for Complex Psychiatric Disorders in Rural FQHCs
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.
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.
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.
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.
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
We found this trial at
13
sites
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