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TEAM Study to Improve Depression Care in Rural CBOCs

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: PHQ9 Score > or = to 12 Exclusion Criteria: A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment

Sites / Locations

  • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  • Overton Brooks VA Medical Center, Shreveport, LA
  • G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life

Secondary Outcome Measures

1) Satisfaction with care, 2) service utilization, 3) Cost, 4) Cost-effectiveness

Full Information

First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00105690
Brief Title
TEAM Study to Improve Depression Care in Rural CBOCs
Official Title
Telemedicine Intervention to Improve Depression Care in Rural CBOCs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.
Detailed Description
BACKGROUND / RATIONALE: Implementing collaborative care for depression in small rural Primary Care (PC) practices without on-site mental health specialists presents unique challenges. We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by PC providers in small rural practices. The Telemedicine Enhanced Antidepressant Management (TEAM) collaborative care intervention was implemented by offsite personnel and all intervention components were implemented using telemedicine technologies. OBJECTIVE(S): Specific Aim 1: Determine whether the TEAM intervention improves quality and outcomes compared to usual care. Specific Aim 2: Determine whether the TEAM intervention will be cost-effective in routine practice settings. METHODS: Seven VISN 16 CBOCs participated in the study. CBOCs were included if they 1) treated >1,000 and <5,000 unique veterans, 2) had no on-site psychiatrists, and 3) had interactive video equipment. Matched CBOCs were randomized to receive the intervention or usual care. Of the 24,882 clinic patients, 73.6% (n=18,306) were successfully screened and 6.9% screened positive for depression (PHQ9 =12). Of those eligible for the study, 91.3% agreed to participate, and 91.9% of those attended their appointment and were consented. Over an 18-month period, 395 patients were enrolled, and 91.1% (n=360) were followed-up at six months. Telephone research interviews were conducted at baseline, six and twelve months. Effectiveness was tested using an intent-to-treat analysis. Cost-effectiveness analysis was assessed from the perspective of the VA. Costs included intervention costs, encounter costs, and medication costs. Quality Adjusted Life Years (QALYs) were calculated using the Quality of Well Being Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine intervention
Primary Outcome Measure Information:
Title
1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
Secondary Outcome Measure Information:
Title
1) Satisfaction with care, 2) service utilization, 3) Cost, 4) Cost-effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PHQ9 Score > or = to 12 Exclusion Criteria: A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Fortney, PhD
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey M. Pyne, MD
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Facility Name
Overton Brooks VA Medical Center, Shreveport, LA
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22211206
Citation
Davis TD, Deen T, Bryant-Bedell K, Tate V, Fortney J. Does minority racial-ethnic status moderate outcomes of collaborative care for depression? Psychiatr Serv. 2011 Nov;62(11):1282-8. doi: 10.1176/ps.62.11.pss6211_1282.
Results Reference
result
PubMed Identifier
23725825
Citation
Fortney JC, Enderle MA, Clothier JL, Otero JM, Williams JS, Pyne JM. Population level effectiveness of implementing collaborative care management for depression. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):455-60. doi: 10.1016/j.genhosppsych.2013.04.010. Epub 2013 May 30.
Results Reference
result
PubMed Identifier
20633741
Citation
Fortney JC, Pyne JM, Edlund MJ, Mittal D. Relationship between antidepressant medication possession and treatment response. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):377-9. doi: 10.1016/j.genhosppsych.2010.03.008. Epub 2010 May 4.
Results Reference
result
PubMed Identifier
20679589
Citation
Pyne JM, Fortney JC, Tripathi SP, Maciejewski ML, Edlund MJ, Williams DK. Cost-effectiveness analysis of a rural telemedicine collaborative care intervention for depression. Arch Gen Psychiatry. 2010 Aug;67(8):812-21. doi: 10.1001/archgenpsychiatry.2010.82.
Results Reference
result
PubMed Identifier
21208594
Citation
Mittal D, Fortney JC, Pyne JM, Wetherell JL. Predictors of persistence of comorbid generalized anxiety disorder among veterans with major depressive disorder. J Clin Psychiatry. 2011 Nov;72(11):1445-51. doi: 10.4088/JCP.10m05981blu. Epub 2010 Dec 14.
Results Reference
result
PubMed Identifier
21208579
Citation
Fortney JC, Pyne JM, Edlund MJ, Stecker T, Mittal D, Robinson DE, Henderson KL. Reasons for antidepressant nonadherence among veterans treated in primary care clinics. J Clin Psychiatry. 2011 Jun;72(6):827-34. doi: 10.4088/JCP.09m05528blu. Epub 2010 Nov 16.
Results Reference
result
PubMed Identifier
20978932
Citation
Deen TL, Fortney JC, Pyne JM. Relationship between satisfaction, patient-centered care, adherence and outcomes among patients in a collaborative care trial for depression. Adm Policy Ment Health. 2011 Sep;38(5):345-55. doi: 10.1007/s10488-010-0322-z.
Results Reference
result
PubMed Identifier
18520312
Citation
Edlund MJ, Fortney JC, Reaves CM, Pyne JM, Mittal D. Beliefs about depression and depression treatment among depressed veterans. Med Care. 2008 Jun;46(6):581-9. doi: 10.1097/MLR.0b013e3181648e46.
Results Reference
result
PubMed Identifier
17158487
Citation
Mittal D, Fortney JC, Pyne JM, Edlund MJ, Wetherell JL. Impact of comorbid anxiety disorders on health-related quality of life among patients with major depressive disorder. Psychiatr Serv. 2006 Dec;57(12):1731-7. doi: 10.1176/ps.2006.57.12.1731.
Results Reference
result
PubMed Identifier
16377361
Citation
Fortney JC, Pyne JM, Edlund MJ, Robinson DE, Mittal D, Henderson KL. Design and implementation of the telemedicine-enhanced antidepressant management study. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):18-26. doi: 10.1016/j.genhosppsych.2005.07.001.
Results Reference
result
PubMed Identifier
21623240
Citation
Fortney JC, Maciejewski ML, Tripathi SP, Deen TL, Pyne JM. A budget impact analysis of telemedicine-based collaborative care for depression. Med Care. 2011 Sep;49(9):872-80. doi: 10.1097/MLR.0b013e31821d2b35.
Results Reference
result
PubMed Identifier
21348556
Citation
Fortney JC, Pyne JM, Steven CA, Williams JS, Hedrick RG, Lunsford AK, Raney WN, Ackerman BA, Ducker LO, Bonner LM, Smith JL. A Web-based clinical decision support system for depression care management. Am J Manag Care. 2010 Nov;16(11):849-54.
Results Reference
result

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TEAM Study to Improve Depression Care in Rural CBOCs

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