LINK: Aftercare Monitoring Project
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Telephone Case Monitoring Aftercare 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 Names:
|
| Active Comparator: Continuing Care as Usual Continuing Care as Usual |
Behavioral: Continuing Care as Usual
Continuing Care as Usual will include standard group outpatient SUD treatment.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rates of Substance Use [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 Outcome Measures
- Psychiatric Symptoms [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.
- Health Related Quality of Life [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1290 |
| 2 | VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS | Topeka | Kansas | United States | 66622 |
| 3 | St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Saint Louis | Missouri | United States | 63106 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: John D. McKellar, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 05-021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Telephone Case Monitoring Aftercare | Continuing Care as Usual |
|---|---|---|
| Arm/Group Description | 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. | Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. |
| Period Title: Overall Study | ||
| STARTED | 213 | 454 |
| COMPLETED | 168 | 359 |
| NOT COMPLETED | 45 | 95 |
Baseline Characteristics
| Arm/Group Title | Telephone Case Monitoring Aftercare | Continuing Care as Usual | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. | Total of all reporting groups |
| Overall Participants | 213 | 454 | 667 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.9
(8.5)
|
51.0
(8.1)
|
51.3
(8.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
10
4.7%
|
21
4.6%
|
31
4.6%
|
| Male |
203
95.3%
|
433
95.4%
|
636
95.4%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telephone Case Monitoring Aftercare | Continuing Care as Usual |
|---|---|---|
| Arm/Group Description | 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. | Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. |
| Measure Participants | 213 | 454 |
| Mean (Standard Error) [percentage of days] |
91.1
(1.79)
|
88.0
(1.81)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telephone Case Monitoring Aftercare | Continuing Care as Usual |
|---|---|---|
| Arm/Group Description | 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. | Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. |
| Measure Participants | 213 | 454 |
| 3 months |
47.22
(1.41)
|
50.50
(1.00)
|
| 6 months |
49.76
(1.42)
|
51.88
(1.02)
|
| 12 months |
48.79
(1.47)
|
51.18
(1.07)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telephone Case Monitoring Aftercare | Continuing Care as Usual |
|---|---|---|
| Arm/Group Description | 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. | Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. |
| Measure Participants | 209 | 443 |
| 3 month PCS |
45.64
(.83)
|
44.92
(.57)
|
| 6 month PCS |
44.54
(.96)
|
43.58
(.66)
|
| 12 month PCS |
43.37
(.91)
|
42.72
(.66)
|
| 3 month MCS |
36.22
(.81)
|
35.13
(.57)
|
| 6 month MCS |
40.81
(1.02)
|
39.09
(.66)
|
| 12 month MCS |
40.72
(.94)
|
40.12
(.69)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events were tracked. There was no tracking of other adverse events. | |||
| Arm/Group Title | Telephone Case Monitoring Aftercare | Continuing Care as Usual | ||
| Arm/Group Description | 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. SAEs were tracked, but AEs were not tracked. | Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. SAEs were tracked, but AEs were not tracked. | ||
All Cause Mortality |
||||
| Telephone Case Monitoring Aftercare | Continuing Care as Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/213 (0%) | 0/454 (0%) | ||
Serious Adverse Events |
||||
| Telephone Case Monitoring Aftercare | Continuing Care as Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 60/213 (28.2%) | 92/454 (20.3%) | ||
| General disorders | ||||
| hosapitalizations | 60/213 (28.2%) | 102 | 92/454 (20.3%) | 206 |
Other (Not Including Serious) Adverse Events |
||||
| Telephone Case Monitoring Aftercare | Continuing Care as Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Todd Wagner |
|---|---|
| Organization | VA Center for Innovation to Implementation |
| Phone | 6504935000 ext 22048 |
| todd.wagner@va.gov |
- IIR 05-021