Alcohol DependenceNCT00265512
LINK: Aftercare Monitoring Project
A study testing Telephone Case Monitoring and Continuing Care as Usual in people with Alcohol Dependence and Drug Dependence, run by VA Office of Research and Development at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcohol Dependence, Drug Dependence
- What is being tested?
- Telephone Case Monitoring and Continuing Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2006to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Completion of less than 14 days of IOP treatment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106
VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS
Topeka, Kansas, 66622
About this study
Official title: Improving Longterm SUD Outcomes With Telephone Case Monitoring
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).
Read the 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.
- Conditions
- Alcohol Dependence, Drug Dependence
- Being tested
- Telephone Case Monitoring, Continuing Care as Usual
- Keywords
- Telemedicine, Aftercare
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Case MonitoringBehavioural
Also called TCM
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 UsualBehavioural
Also called CCAU
Continuing Care as Usual will include standard group outpatient SUD treatment.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Case Monitoring Aftercare | Active comparator | Telephone Case Monitoring Aftercare Receives: Behavioral: Telephone Case Monitoring |
| Continuing Care as Usual | Active comparator | Continuing Care as Usual Receives: Behavioral: Continuing Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Rates of substance use measured at 3 months
Secondary outcomes (2)
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.
Measured: Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization
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.
Measured: 3 months, 6 months and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D. McKellar, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265512
- Sponsor's protocol ID
- IIR 05-021
- Status last verified
- Jul 2018
- First submitted
- 12 Dec 2005
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.
PubMed 22651986Oser M, Cucciare M, McKellar J, Weingardt K. Correlates of hazardous drinking among Veterans with and without hepatitis C. J Behav Med. 2012 Dec;35(6):634-41. doi: 10.1007/s10865-011-9394-9. Epub 2012 Jan 11.
PubMed 22234384Austin J, McKellar JD, Moos R. The influence of co-occurring axis I disorders on treatment utilization and outcome in homeless patients with substance use disorders. Addict Behav. 2011 Sep;36(9):941-4. doi: 10.1016/j.addbeh.2011.05.001. Epub 2011 May 7.
PubMed 21620571Oser ML, McKellar J, Moos BS, Moos RH. Changes in ambivalence mediate the relation between entering treatment and change in alcohol use and problems. Addict Behav. 2010 Apr;35(4):367-9. doi: 10.1016/j.addbeh.2009.10.024. Epub 2009 Oct 30.
PubMed 19926399Barbosa PV, Thomas IC, Srinivas S, Buyyounouski MK, Chung BI, Chertow GM, Asch SM, Wagner TH, Brooks JD, Leppert JT. Overall Survival in Patients with Localized Prostate Cancer in the US Veterans Health Administration: Is PIVOT Generalizable? Eur Urol. 2016 Aug;70(2):227-30. doi: 10.1016/j.eururo.2016.02.037. Epub 2016 Mar 2.
PubMed 26948397Wagner TH, Burstin H, Frakt AB, Krein SL, Lorenz K, Maciejewski ML, Pizer SD, Weiner M, Yoon J, Zulman DM, Asch SM. Opportunities to Enhance Value-Related Research in the U.S. Department of Veterans Affairs. J Gen Intern Med. 2016 Apr;31 Suppl 1(Suppl 1):78-83. doi: 10.1007/s11606-015-3538-5. No abstract available.
PubMed 26951279Gidwani R, Joyce N, Kinosian B, Faricy-Anderson K, Levy C, Miller SC, Ersek M, Wagner T, Mor V. Gap between Recommendations and Practice of Palliative Care and Hospice in Cancer Patients. J Palliat Med. 2016 Sep;19(9):957-63. doi: 10.1089/jpm.2015.0514. Epub 2016 May 26.
PubMed 27228478
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Longterm SUD Outcomes With Telephone Case Monitoring
- ClinicalTrials.gov ID
- NCT00265512
- Acronym / sponsor ID
- IIR 05-021
- Conditions
- Alcohol Dependence, Drug Dependence
- Keywords
- Telemedicine, Aftercare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Case Monitoring Aftercare | Active comparator | Behavioral: Telephone Case MonitoringTelephone Case Monitoring Aftercare |
| Continuing Care as Usual | Active comparator | Behavioral: Continuing Care as UsualContinuing Care as Usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Completion of less than 14 days of IOP treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Case MonitoringAlso: TCMTelephone 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. | Behavioural | Telephone Case Monitoring Aftercare |
| Continuing Care as UsualAlso: CCAUContinuing Care as Usual will include standard group outpatient SUD treatment. | Behavioural | Continuing Care as Usual |
Primary outcome
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).
2 secondary outcomes
Psychiatric Symptoms
Time frame: Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization
Health Related Quality of Life
Time frame: 3 months, 6 months and 12 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22651986McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.
- Results publication: PubMed 22234384Oser M, Cucciare M, McKellar J, Weingardt K. Correlates of hazardous drinking among Veterans with and without hepatitis C. J Behav Med. 2012 Dec;35(6):634-41. doi: 10.1007/s10865-011-9394-9. Epub 2012 Jan 11.
- Results publication: PubMed 21620571Austin J, McKellar JD, Moos R. The influence of co-occurring axis I disorders on treatment utilization and outcome in homeless patients with substance use disorders. Addict Behav. 2011 Sep;36(9):941-4. doi: 10.1016/j.addbeh.2011.05.001. Epub 2011 May 7.
- Results publication: PubMed 19926399Oser ML, McKellar J, Moos BS, Moos RH. Changes in ambivalence mediate the relation between entering treatment and change in alcohol use and problems. Addict Behav. 2010 Apr;35(4):367-9. doi: 10.1016/j.addbeh.2009.10.024. Epub 2009 Oct 30.
- Results publication: PubMed 26948397Barbosa PV, Thomas IC, Srinivas S, Buyyounouski MK, Chung BI, Chertow GM, Asch SM, Wagner TH, Brooks JD, Leppert JT. Overall Survival in Patients with Localized Prostate Cancer in the US Veterans Health Administration: Is PIVOT Generalizable? Eur Urol. 2016 Aug;70(2):227-30. doi: 10.1016/j.eururo.2016.02.037. Epub 2016 Mar 2.
- Results publication: PubMed 26951279Wagner TH, Burstin H, Frakt AB, Krein SL, Lorenz K, Maciejewski ML, Pizer SD, Weiner M, Yoon J, Zulman DM, Asch SM. Opportunities to Enhance Value-Related Research in the U.S. Department of Veterans Affairs. J Gen Intern Med. 2016 Apr;31 Suppl 1(Suppl 1):78-83. doi: 10.1007/s11606-015-3538-5. No abstract available.
- Results publication: PubMed 27228478Gidwani R, Joyce N, Kinosian B, Faricy-Anderson K, Levy C, Miller SC, Ersek M, Wagner T, Mor V. Gap between Recommendations and Practice of Palliative Care and Hospice in Cancer Patients. J Palliat Med. 2016 Sep;19(9):957-63. doi: 10.1089/jpm.2015.0514. Epub 2016 May 26.
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. McKellar, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Case Monitoring and Continuing Care as Usual in people with Alcohol Dependence and Drug Dependence, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Substance Use (time frame: Rates of substance use measured at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00265512, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.