LINK: Aftercare Monitoring Project
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00265512|
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : October 17, 2014
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment|
|Alcohol Dependence Drug Dependence||Behavioral: Telephone Case Monitoring Behavioral: Continuing Care as Usual|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||667 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Longterm SUD Outcomes With Telephone Case Monitoring|
|Study Start Date :||November 2006|
|Primary Completion Date :||June 2009|
|Study Completion Date :||January 2010|
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
- 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).
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265512
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|United States, Kansas|
|VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS|
|Topeka, Kansas, United States, 66622|
|United States, Missouri|
|St. Louis VA Medical Center John Cochran Division, St. Louis, MO|
|St Louis, Missouri, United States, 63106|
|Principal Investigator:||John D. McKellar, PhD||VA Palo Alto Health Care System, Palo Alto, CA|