search
Back to results

LINK: Aftercare Monitoring Project

Primary Purpose

Alcohol Dependence, Drug Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone Case Monitoring
Continuing Care as Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Telemedicine, Aftercare

Eligibility Criteria

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

Inclusion Criteria: Participants will be recruited from all patients who complete at least 14 days of intensive outpatient (IOP) substance use disorder treatment over an 18-month period in 2 VA IOP SUD programs. Exclusion Criteria: Completion of less than 14 days of IOP treatment.

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA
  • VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Telephone Case Monitoring Aftercare

Continuing Care as Usual

Arm Description

Telephone Case Monitoring Aftercare

Continuing Care as Usual

Outcomes

Primary Outcome Measures

Rates of Substance Use
Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).

Secondary Outcome Measures

Psychiatric Symptoms
3 month, 6 month and 12 month measures of psychiatric symptoms, as measured by the Brief Symptom Inventory (BSI). Minimum observed score was 22; maximum observed score was 110. Higher score is worse. Minimum score possible is 22. Maximum score possible is 110.
Health Related Quality of Life
Physical and mental health subscales from the 12-item Medical Outcomes Study Short-form Health Survey, adapted for Veterans (VR-12). Observed scores on the MCS ranged from 2.89 to 70.39. Scores on the PCS ranged from 13.26 to 70.10. Higher scores denote better health. The minimum and maximum scores possible are 0 and 100, respectively.

Full Information

First Posted
December 12, 2005
Last Updated
July 26, 2018
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00265512
Brief Title
LINK: Aftercare Monitoring Project
Official Title
Improving Longterm SUD Outcomes With Telephone Case Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. This randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care).
Detailed Description
Background: The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. The proposed randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care). Objectives: The objective of this research is to test, in a randomized clinical trial, whether in-person CCAU following intensive outpatient SUD treatment leads to better SUD outcomes when compared with TCM. In addition, we will investigate whether continuing care condition interacts with distance from providers such that telephone case monitoring (TCM) produces increasingly stronger results relative to continuing care as usual (CCAU) as distance from care increases. Should we find an interaction, we will test whether the interaction is due to TCM producing better proximal outcomes such as level of participation in continuing care and satisfaction with treatment. Finally, we will investigate the cost of providing telephone care relative to continuing care as usual. Methods: The design of this study is a randomized controlled trial of telephone case monitoring versus face-to-face continuing care as usual with 2 sites and up to 500 patients per site recruited over 1.5 years for a total of up to 1000 patients. Patients will be involved in the intervention for up to 6 months and data collection will occur at baseline, 3, 6 and 12 months via mailed surveys. Data of interest include self-report of substance use, psychiatric symptoms, and quality of life. Data analyses will be conducted using hierarchical linear modeling. Status: Patient recruitment has ended. Treatment and follow-up are on-going.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Drug Dependence
Keywords
Telemedicine, Aftercare

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Case Monitoring Aftercare
Arm Type
Active Comparator
Arm Description
Telephone Case Monitoring Aftercare
Arm Title
Continuing Care as Usual
Arm Type
Active Comparator
Arm Description
Continuing Care as Usual
Intervention Type
Behavioral
Intervention Name(s)
Telephone Case Monitoring
Other Intervention Name(s)
TCM
Intervention Description
Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Continuing Care as Usual
Other Intervention Name(s)
CCAU
Intervention Description
Continuing Care as Usual will include standard group outpatient SUD treatment.
Primary Outcome Measure Information:
Title
Rates of Substance Use
Description
Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).
Time Frame
Rates of substance use measured at 3 months
Secondary Outcome Measure Information:
Title
Psychiatric Symptoms
Description
3 month, 6 month and 12 month measures of psychiatric symptoms, as measured by the Brief Symptom Inventory (BSI). Minimum observed score was 22; maximum observed score was 110. Higher score is worse. Minimum score possible is 22. Maximum score possible is 110.
Time Frame
Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization
Title
Health Related Quality of Life
Description
Physical and mental health subscales from the 12-item Medical Outcomes Study Short-form Health Survey, adapted for Veterans (VR-12). Observed scores on the MCS ranged from 2.89 to 70.39. Scores on the PCS ranged from 13.26 to 70.10. Higher scores denote better health. The minimum and maximum scores possible are 0 and 100, respectively.
Time Frame
3 months, 6 months and 12 months after randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be recruited from all patients who complete at least 14 days of intensive outpatient (IOP) substance use disorder treatment over an 18-month period in 2 VA IOP SUD programs. Exclusion Criteria: Completion of less than 14 days of IOP treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. McKellar, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66622
Country
United States
Facility Name
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22651986
Citation
McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.
Results Reference
result
PubMed Identifier
22234384
Citation
Oser M, Cucciare M, McKellar J, Weingardt K. Correlates of hazardous drinking among Veterans with and without hepatitis C. J Behav Med. 2012 Dec;35(6):634-41. doi: 10.1007/s10865-011-9394-9. Epub 2012 Jan 11.
Results Reference
result
PubMed Identifier
21620571
Citation
Austin J, McKellar JD, Moos R. The influence of co-occurring axis I disorders on treatment utilization and outcome in homeless patients with substance use disorders. Addict Behav. 2011 Sep;36(9):941-4. doi: 10.1016/j.addbeh.2011.05.001. Epub 2011 May 7.
Results Reference
result
PubMed Identifier
19926399
Citation
Oser ML, McKellar J, Moos BS, Moos RH. Changes in ambivalence mediate the relation between entering treatment and change in alcohol use and problems. Addict Behav. 2010 Apr;35(4):367-9. doi: 10.1016/j.addbeh.2009.10.024. Epub 2009 Oct 30.
Results Reference
result
PubMed Identifier
26948397
Citation
Barbosa PV, Thomas IC, Srinivas S, Buyyounouski MK, Chung BI, Chertow GM, Asch SM, Wagner TH, Brooks JD, Leppert JT. Overall Survival in Patients with Localized Prostate Cancer in the US Veterans Health Administration: Is PIVOT Generalizable? Eur Urol. 2016 Aug;70(2):227-30. doi: 10.1016/j.eururo.2016.02.037. Epub 2016 Mar 2.
Results Reference
result
PubMed Identifier
26951279
Citation
Wagner TH, Burstin H, Frakt AB, Krein SL, Lorenz K, Maciejewski ML, Pizer SD, Weiner M, Yoon J, Zulman DM, Asch SM. Opportunities to Enhance Value-Related Research in the U.S. Department of Veterans Affairs. J Gen Intern Med. 2016 Apr;31 Suppl 1(Suppl 1):78-83. doi: 10.1007/s11606-015-3538-5. No abstract available.
Results Reference
result
PubMed Identifier
27228478
Citation
Gidwani R, Joyce N, Kinosian B, Faricy-Anderson K, Levy C, Miller SC, Ersek M, Wagner T, Mor V. Gap between Recommendations and Practice of Palliative Care and Hospice in Cancer Patients. J Palliat Med. 2016 Sep;19(9):957-63. doi: 10.1089/jpm.2015.0514. Epub 2016 May 26.
Results Reference
result

Learn more about this trial

LINK: Aftercare Monitoring Project

We'll reach out to this number within 24 hrs