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| Sponsored by: |
University of Arkansas |
| Information provided by: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00439452 |
Purpose
Across the country, Community Health Centers are participating in the Health Disparities Collaboratives sponsored by the Health Services Resources and Services Administration (HRSA). The Health Disparities Collaboratives integrate three complementary conceptual frameworks: 1) the Institute for Healthcare Improvement's (IHI) Breakthrough Series Model; 2) the Improvement Model (i.e., Plan-Do-Study-Act cycles); and 3) Wagner's Chronic Care Model. The Chronic Care model uses patient self-management, delivery system re-design, decision support, and clinical information systems to maximize the effectiveness of interactions between prepared proactive care teams and informed activated patients with chronic illnesses such as diabetes, asthma, and depression. The Chronic Care model for depression, also known as Collaborative Care, involves primary care providers working with a depression care team comprising non-physicians (e.g., nurses, pharmacists) and mental health specialists (e.g., psychiatrists). Practice-based collaborative care involves primary care providers working with an on-site depression care team. In contrast, telemedicine-based collaborative care involves primary care providers working with an off-site depression care team using telemedicine technologies. The purpose of this research project is to compare the effectiveness and cost effectiveness of practice-based and telemedicine-based collaborative care in Community Health Centers (without on-site mental health specialists) implementing the Health Disparities Collaborative for depression.
| Condition | Intervention |
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Depression |
Other: On-site intervention team Behavioral: Off Site depression team |
| MedlinePlus related topics: | Depression |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Telemedicine-Based Collaborative Care to Reduce Rural Disparities |
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| I: Active Comparator |
Other: On-site intervention team
The practice-based intervention is a collaborative care model that applies principles of disease management and delivers evidence-based pharmacotherapy depression treatments. The on-site depression team includes a primary care provider (MD, APN) and a care manager (LPN, social worker). The telemedicine-based intervention is a collaborative care model that applies principles of disease management and delivers evidence-based pharmacotherapy and psychotherapy depression treatments.
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| II: Active Comparator |
Behavioral: Off Site depression team
The off-site depression team is made up of a depression care manager (RN), a clinical pharmacist (Pharm D), a psychologist (PhD), and a psychiatrist (MD). The off-site team communicates with patients and on-site providers through the use of telephone, fax, secure email, interactive video, and a web-based clinical information system.
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An experimental study design and an intent-to-treat analysis will be used to determine the effectiveness and cost-effectiveness of telemedicine-based collaborative care relative to practice-based collaborative care. The research setting will be six Community Health Centers located in medically underserved areas of Arkansas which serve rural, low income and minority populations. Potentially eligible patients will be identified through screening by Community Health Centers clinic staff or primary care provider referrals. Patients eligible for the study will be consented and randomized to receive either telemedicine-based or practice-based collaborative care, and followed for 18 months to assess processes and outcomes. On-site clinical staff will screen patients for depression over an 18 month period and refer all patients with clinically significant depression (PHQ9≥10) to the study.
Two types of health care professionals will be involved in the practice-based collaborative care model: 1) primary care providers (MD and RNP); and 2) a depression care manager (LPN or Social Worker). The on-site care managers will provide care management activities by phone or face-to-face.
Five types of health care professionals will be involved in the telemedicine-based collaborative care model: 1) primary care providers (MD and RNP); 2) a depression nurse care manager (RN); 3) clinical pharmacist (PharmD); 4) tele-psychologist (PhD); and 5) a tele-psychiatrist (MD). The primary care providers will be located at the Community Health Centers. The off-site depression care team will be located at the clinics of the University of Arkansas for Medical Sciences, Department of Psychiatry. The on-site primary care providers will prescribe medications and schedule all appointments. The off-site nurse care manager will conduct all care management activities by telephone. The off-site clinical pharmacist will conduct medication histories and provide medication management by telephone. The off-site tele-psychologist will conduct evidence-based psychotherapy (cognitive behavioral therapy) via interactive video. The off-site tele-psychiatrist will conduct interactive-video consultations, train and supervise the depression care team, and conduct provider education.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John Fortney, PhD | 501-660-7527 | FortneyJohnC@uams.edu |
| United States, Arkansas | |||||
| University of Arkansas for Medical Science | Recruiting | ||||
| Little Rock, Arkansas, United States, 72205 | |||||
| Contact: John C Fortney, Ph.D. 501-660-7527 FortneyJohnC@uams.edu | |||||
| Principal Investigator: John C Fortney, PhD. | |||||
| University of Arkansas |
| Principal Investigator: | John C Fortney, PhD | University of Arkansas |
More Information
| Responsible Party: | University of Arkansas for Medical Sciences ( Carole Hamon ) |
| Study ID Numbers: | 61251 |
| First Received: | February 22, 2007 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00439452 |
| Health Authority: | United States: Institutional Review Board |
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