Telemedicine-Based Collaborative Care to Reduce Rural Disparities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00439452
First received: February 22, 2007
Last updated: August 31, 2011
Last verified: August 2011
  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
Depression
Other: Telemedicine-Based Collaborative Care
Other: Practice Based Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Telemedicine-Based Collaborative Care to Reduce Rural Disparities

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telemedicine-Based Collaborative Care
Telemedicine-Based Collaborative Care - Off-site depression care team (telephone nurse care manager, telephone pharmacist, tele-psychologist and tele-psychiatrist) works collaboratively with on-site primary care providers. Telephone nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response. Telephone pharmacist activities include documenting medication histories and conducting medication management. Tele-psychologist activities include providing cognitive behavioral therapy via interactive video. Tele-psychiatrist activities include conducting patient consultation via interactive video.
Other: Telemedicine-Based Collaborative Care
Off-site depression care team (telephone nurse care manager, telephone pharmacist, tele-psychologist and tele-psychiatrist) works collaboratively with on-site primary care providers. Telephone nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response. Telephone pharmacist activities include documenting medication histories and conducting medication management. Tele-psychologist activities include providing cognitive behavioral therapy via interactive video. Tele-psychiatrist activities include conducting patient consultation via interactive video.
Active Comparator: Practice Based Collaborative Care
One-site nurse care manager works collaboratively with on-site primary care providers. Nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
Other: Practice Based Collaborative Care
One-site nurse care manager works collaboratively with on-site primary care providers. Nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically Significant Depression

Exclusion Criteria:

  • Sub-threshold Depression,
  • Non-english speaking,
  • Patients not having telephone access,
  • Bereaved,
  • Suicidal,
  • Currently being treated by a mental health specialist,
  • Bipolar disorder,
  • Psychotic disorders,
  • Drug or alcohol dependence,
  • Cognitively impaired,
  • Terminal illness,
  • Having a court appointed guardian, or
  • Pregnant (if applicable)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439452

Locations
United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: John C Fortney, PhD University of Arkansas
  More Information

No publications provided by University of Arkansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00439452     History of Changes
Other Study ID Numbers: 61251
Study First Received: February 22, 2007
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014