Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265512
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2005-12-12
Brief Title:
LINK Aftercare Monitoring Project
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Longterm SUD Outcomes With Telephone Case Monitoring
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of substance use disorders SUD in the VA is rising making SUDs 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 CCAUstandard outpatient care
Detailed Description:
Background The prevalence of substance use disorders SUD in the VA is rising making SUDs 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 CCAUstandard 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 15 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
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 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None