Alcohol Dependence, Drug Dependence
Conditions
Keywords
Telemedicine, Aftercare
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).
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.
Interventions
BEHAVIORALTelephone 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.
BEHAVIORALContinuing Care as Usual
Continuing Care as Usual will include standard group outpatient SUD treatment.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telephone Case Monitoring Aftercare 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. | 213 |
| Continuing Care as Usual Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. | 454 |
| Total | 667 |
Baseline characteristics
| Characteristic | Telephone Case Monitoring Aftercare | Continuing Care as Usual | Total |
|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 8.5 | 51.0 years STANDARD_DEVIATION 8.1 | 51.3 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 31 Participants |
| Sex: Female, Male Male | 203 Participants | 433 Participants | 636 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 0 / 454 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 60 / 213 | 92 / 454 |
Outcome results
Primary
Rates of Substance Use
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telephone Case Monitoring Aftercare | Rates of Substance Use | 91.1 percentage of days | Standard Error 1.79 |
| Continuing Care as Usual | Rates of Substance Use | 88.0 percentage of days | Standard Error 1.81 |
Secondary
Health Related Quality of Life
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Case Monitoring Aftercare | Health Related Quality of Life | 3 month MCS | 36.22 score on a scale | Standard Error 0.81 |
| Telephone Case Monitoring Aftercare | Health Related Quality of Life | 12 month PCS | 43.37 score on a scale | Standard Error 0.91 |
| Telephone Case Monitoring Aftercare | Health Related Quality of Life | 6 month MCS | 40.81 score on a scale | Standard Error 1.02 |
| Telephone Case Monitoring Aftercare | Health Related Quality of Life | 6 month PCS | 44.54 score on a scale | Standard Error 0.96 |
| Telephone Case Monitoring Aftercare | Health Related Quality of Life | 12 month MCS | 40.72 score on a scale | Standard Error 0.94 |
| Telephone Case Monitoring Aftercare | Health Related Quality of Life | 3 month PCS | 45.64 score on a scale | Standard Error 0.83 |
| Continuing Care as Usual | Health Related Quality of Life | 12 month MCS | 40.12 score on a scale | Standard Error 0.69 |
| Continuing Care as Usual | Health Related Quality of Life | 3 month PCS | 44.92 score on a scale | Standard Error 0.57 |
| Continuing Care as Usual | Health Related Quality of Life | 12 month PCS | 42.72 score on a scale | Standard Error 0.66 |
| Continuing Care as Usual | Health Related Quality of Life | 3 month MCS | 35.13 score on a scale | Standard Error 0.57 |
| Continuing Care as Usual | Health Related Quality of Life | 6 month MCS | 39.09 score on a scale | Standard Error 0.66 |
| Continuing Care as Usual | Health Related Quality of Life | 6 month PCS | 43.58 score on a scale | Standard Error 0.66 |
Secondary
Psychiatric Symptoms
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Case Monitoring Aftercare | Psychiatric Symptoms | 12 months | 48.79 score on a scale | Standard Error 1.47 |
| Telephone Case Monitoring Aftercare | Psychiatric Symptoms | 3 months | 47.22 score on a scale | Standard Error 1.41 |
| Telephone Case Monitoring Aftercare | Psychiatric Symptoms | 6 months | 49.76 score on a scale | Standard Error 1.42 |
| Continuing Care as Usual | Psychiatric Symptoms | 3 months | 50.50 score on a scale | Standard Error 1 |
| Continuing Care as Usual | Psychiatric Symptoms | 6 months | 51.88 score on a scale | Standard Error 1.02 |
| Continuing Care as Usual | Psychiatric Symptoms | 12 months | 51.18 score on a scale | Standard Error 1.07 |