Substance Use Disorders Clinical Trial
— PCASTOfficial title:
Comparative Study Effectiveness of Clinical Decision-Making Processes Required by Public Health Systems Study
NCT number | NCT03486028 |
Other study ID # | 0216289 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 31, 2018 |
Est. completion date | October 27, 2019 |
Verified date | November 2019 |
Source | RTI International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
California counties are in the process of implementing a Centers for Medicare and Medicaid
Services Medicaid 1115 Substance Use Disorder (SUD) demonstration. The demonstration requires
that patients be assigned to addiction treatment settings and levels of care systematically,
using comprehensive biopsychosocial assessments and guided by the American Society of
Addiction Medicine (ASAM) patient placement criteria.
RTI International, a nonprofit research institute, and University of California Los Angeles
(UCLA) Integrated Substance Abuse Programs have been awarded a contract from the Patient
Centered Outcomes Research Institute (PCORI) to study the effects of the ASAM implementation
in California. The California 1115 SUD demonstration provides a unique opportunity to learn
about the benefits and challenges resulting from system-wide implementation of ASAM criteria.
The study will involve surveying patients in counties that are using the ASAM criteria and in
counties that have not yet adopted the ASAM criteria. Medicaid patients receiving addiction
treatment will be offered the opportunity participate in the study and to be surveyed about
their experiences in treatment. The study will also analyze data from the California Outcomes
Management System (CalOMS) and conduct interviews with providers, patients, and policymakers
in the state. The results of the study will help inform California's efforts to continually
improve its addiction treatment systems to better meet the needs of it communities. This
study will also produce important and useful information to patients seeking treatment for
addiction, and their providers, SUD system administrators, and payers.
Status | Completed |
Enrollment | 991 |
Est. completion date | October 27, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Individuals age 19 or older - Receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries. Exclusion Criteria: - Less than 19 years old - Not receiving treatment for addiction in specialty addiction treatment programs licensed in California - Not Medicaid beneficiaries |
Country | Name | City | State |
---|---|---|---|
United States | RTI International | Research Triangle Park | North Carolina |
Lead Sponsor | Collaborator |
---|---|
RTI International | Patient-Centered Outcomes Research Institute, University of California Integrated Substance Abuse Programs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Retention | Retention in treatment for at least 14 days is a validated outcome measure and has been shown to be predictive of reduced substance use, 2-year mortality, criminal justice involvement, and detox episodes. Retention in treatment can be measured with the CalOMS data. | Up to one year | |
Primary | Substance Use Reduction | Abstinence and reduction in substance use is necessary for patients to achieve recovery and improved psychosocial functioning. We will measure this patient reported outcome (PRO) using the patient survey and CalOMS data. Through the patient survey, we will ask about use of any alcohol in the past 30 days, use of any drugs in the last 30 days, and the number of heavy drinking days in the last 30 days. These data will be collected from patients 3 months from treatment-episode initiation. Substance use is also collected from all patients treated in public SUD clinics in California at the beginning and end of each treatment episode and is recorded into the CalOMS data. | Up to one year | |
Secondary | Treatment setting used at treatment initiation | Use of the ASAM criteria is anticipated to improve treatment outcomes (i.e., treatment retention and substance use) by increasing the use of more appropriate treatment settings for each patient, such as shifting the number of patients using residential, intensive outpatient, and opioid treatment programs. The treatment setting of each patient is tracked in the CalOMS data. Specifically, use of the following types of care is captured: (1) outpatient treatment, (2) intensive outpatient treatment, (3) outpatient detoxification, (4) residential detoxification (non-hospital), (5) residential detoxification (hospital), (6) residential treatment (30 days or less), and (7) residential treatment (30 days or more). Using the CalOMS data, we will test whether the distribution of the treatment setting used at treatment initiation changes after ASAM implementation. | Up to one year | |
Secondary | Treatment option communication | It is expected that ASAM implementation will improve communication from providers to patients about treatment options. We will assess this outcome through the patient survey. | Up to one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05660434 -
Using Aromatherapy in Substance Use Disorder
|
N/A | |
Recruiting |
NCT05338268 -
Substance Use and Loneliness
|
N/A | |
Completed |
NCT03954184 -
E-health Implementation (Iowa)
|
N/A | |
Completed |
NCT04098614 -
Barriers to Substance Use Disorder Recovery
|
N/A | |
Completed |
NCT03590106 -
Cardiac Surgery Peer Recovery Support Program
|
N/A | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Terminated |
NCT03517111 -
The Impact of a Parenting Intervention on Latino Youth Health Behaviors
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT04401215 -
Technologically-Augmented Referrals to Mitigate Addiction Consequences
|
N/A | |
Not yet recruiting |
NCT06187701 -
Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients
|
N/A | |
Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
Active, not recruiting |
NCT02382042 -
Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans
|
N/A | |
Completed |
NCT01237366 -
Study Targeting Affect Regulation
|
Phase 1/Phase 2 | |
Terminated |
NCT01356667 -
Drum-Assisted Therapy for Native Americans
|
N/A | |
Completed |
NCT00708890 -
Twelve Step Based Self-help Groups for Substance Related Disorders
|
N/A | |
Active, not recruiting |
NCT04048850 -
Zepatier in Patients With Substance Use
|
||
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 | |
Recruiting |
NCT06094972 -
The Effectiveness of A-CRA in Compulsory Institutional Care for Youth
|
N/A |