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| Tracking Information | |||||
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| First Received Date ICMJE | February 22, 2007 | ||||
| Last Updated Date | July 16, 2009 | ||||
| Start Date ICMJE | May 2007 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To compare processes and outcomes between CHC patients receiving practice-based collaborative care to CHC patients receiving telemedicine-based collaborative care (OUTREACH intervention). [ Time Frame: 6, 12, 18 months after baseline ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00439452 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Telemedicine-Based Collaborative Care to Reduce Rural Disparities | ||||
| Official Title ICMJE | Telemedicine-Based Collaborative Care to Reduce Rural Disparities | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | May 2011 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00439452 | ||||
| Responsible Party | Carole Hamon, University of Arkansas for Medical Sciences | ||||
| Study ID Numbers ICMJE | 61251 | ||||
| Study Sponsor ICMJE | University of Arkansas | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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