LINK: Aftercare Monitoring Project

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00265512
First received: December 12, 2005
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention
Alcohol Dependence
Drug Dependence
Behavioral: Telephone Case Monitoring
Behavioral: Continuing Care as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Longterm SUD Outcomes With Telephone Case Monitoring

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Rates of Substance Use [ Time Frame: Rates of substance use measured at 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study. ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study. ] [ Designated as safety issue: No ]

Enrollment: 667
Study Start Date: November 2006
Study Completion Date: January 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Telephone Case Monitoring Aftercare
Behavioral: Telephone Case Monitoring
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.
Other Name: TCM
Active Comparator: Arm 2
Continuing Care as Usual
Behavioral: Continuing Care as Usual
Continuing Care as Usual will include standard group outpatient SUD treatment.
Other Name: CCAU

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT00265512

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63125
Sponsors and Collaborators
Investigators
Principal Investigator: John D. McKellar, PhD VA Palo Alto Health Care System
  More Information