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Completed

NCT Number: NCT00265512

LINK: Aftercare Monitoring Project

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone Case Monitoring

Behavioral

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 names: TCM

Continuing Care as Usual

Behavioral

Continuing Care as Usual will include standard group outpatient SUD treatment.

Other names: CCAU

Primary outcomes

  1. Rates of Substance Use

    Time frame: Rates of substance use measured at 3 months

    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 outcomes

  1. Psychiatric Symptoms

    Time frame: Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization

    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.

  2. Health Related Quality of Life

    Time frame: 3 months, 6 months and 12 months after randomization

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Improving Longterm SUD Outcomes With Telephone Case Monitoring

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Dec 14, 2005
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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