Trial Outcomes & Findings for LINK: Aftercare Monitoring Project (NCT NCT00265512)

NCT ID: NCT00265512

Last Updated: 2019-01-16

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 667 participants
• Primary outcome timeframe: Rates of substance use measured at 3 months
• Results posted on: 2019-01-16

Participant Flow

Participant milestones

Measure	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.	Continuing Care as Usual Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
Overall Study STARTED	213	454
Overall Study COMPLETED	168	359
Overall Study NOT COMPLETED	45	95

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LINK: Aftercare Monitoring Project

Baseline characteristics by cohort

Measure	Telephone Case Monitoring Aftercare n=213 Participants 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 n=454 Participants Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.	Total n=667 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 8.5 • n=5 Participants	51.0 years STANDARD_DEVIATION 8.1 • n=7 Participants	51.3 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	21 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	203 Participants n=5 Participants	433 Participants n=7 Participants	636 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Continuing Care as Usual n=454 Participants Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.	Telephone Case Monitoring Aftercare n=213 Participants 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.
Rates of Substance Use	88.0 percentage of days Standard Error 1.81	91.1 percentage of days Standard Error 1.79

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuing Care as Usual n=454 Participants Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.	Telephone Case Monitoring Aftercare n=213 Participants 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.
Psychiatric Symptoms 12 months	51.18 score on a scale Standard Error 1.07	48.79 score on a scale Standard Error 1.47
Psychiatric Symptoms 3 months	50.50 score on a scale Standard Error 1.00	47.22 score on a scale Standard Error 1.41
Psychiatric Symptoms 6 months	51.88 score on a scale Standard Error 1.02	49.76 score on a scale Standard Error 1.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuing Care as Usual n=443 Participants Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.	Telephone Case Monitoring Aftercare n=209 Participants 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.
Health Related Quality of Life 3 month MCS	35.13 score on a scale Standard Error .57	36.22 score on a scale Standard Error .81
Health Related Quality of Life 3 month PCS	44.92 score on a scale Standard Error .57	45.64 score on a scale Standard Error .83
Health Related Quality of Life 6 month PCS	43.58 score on a scale Standard Error .66	44.54 score on a scale Standard Error .96
Health Related Quality of Life 12 month PCS	42.72 score on a scale Standard Error .66	43.37 score on a scale Standard Error .91
Health Related Quality of Life 6 month MCS	39.09 score on a scale Standard Error .66	40.81 score on a scale Standard Error 1.02
Health Related Quality of Life 12 month MCS	40.12 score on a scale Standard Error .69	40.72 score on a scale Standard Error .94

Adverse Events

Telephone Case Monitoring Aftercare

Serious events: 60 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuing Care as Usual

Serious events: 92 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telephone Case Monitoring Aftercare n=213 participants at risk 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 n=454 participants at risk Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment. SAEs were tracked, but AEs were not tracked.
General disorders hosapitalizations	28.2% 60/213 • Number of events 102 Serious Adverse Events were tracked. There was no tracking of other adverse events.	20.3% 92/454 • Number of events 206 Serious Adverse Events were tracked. There was no tracking of other adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Todd Wagner

VA Center for Innovation to Implementation

Phone: 6504935000

Email: todd.wagner@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place