NCT00439452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

3.6 years

First QC Date

February 22, 2007

Last Update Submit

August 31, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • To compare processes and outcomes between CHC patients receiving practice-based collaborative care to CHC patients receiving telemedicine-based collaborative care (OUTREACH intervention).

    6, 12, 18 months after baseline

Study Arms (2)

Telemedicine-Based Collaborative Care

ACTIVE COMPARATOR

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

Practice Based Collaborative Care

ACTIVE COMPARATOR

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

Interventions

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.

Telemedicine-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.

Practice Based Collaborative Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically Significant Depression

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205, United States

Location

Related Publications (5)

  • Mittal D, Chekuri L, Lu L, Fortney JC. Demographic, Economic, and Clinical Correlates of Depression Treatment Response in an Underserved Primary Care Population. J Clin Psychiatry. 2014 Aug 26;75(8):848-854. doi: 10.4088/JCP.13m08954.

  • Grubbs KM, Fortney JC, Pyne J, Mittal D, Ray J, Hudson TJ. A Comparison of Collaborative Care Outcomes in Two Health Care Systems: VA Clinics and Federally Qualified Health Centers. Psychiatr Serv. 2018 Apr 1;69(4):431-437. doi: 10.1176/appi.ps.201700067. Epub 2018 Jan 16.

  • Pyne JM, Fortney JC, Mouden S, Lu L, Hudson TJ, Mittal D. Cost-effectiveness of on-site versus off-site collaborative care for depression in rural FQHCs. Psychiatr Serv. 2015 May 1;66(5):491-9. doi: 10.1176/appi.ps.201400186. Epub 2015 Feb 17.

  • Fortney JC, Pyne JM, Mouden SB, Mittal D, Hudson TJ, Schroeder GW, Williams DK, Bynum CA, Mattox R, Rost KM. Practice-based versus telemedicine-based collaborative care for depression in rural federally qualified health centers: a pragmatic randomized comparative effectiveness trial. Am J Psychiatry. 2013 Apr;170(4):414-25. doi: 10.1176/appi.ajp.2012.12050696.

  • Deen TL, Fortney JC, Schroeder G. Patient acceptance of and initiation and engagement in telepsychotherapy in primary care. Psychiatr Serv. 2013 Apr 1;64(4):380-4. doi: 10.1176/appi.ps.201200198.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • John C Fortney, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 23, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations