Patient Centered Assessment and Substance Use Disorder Treatment Study (PCAST)

NCT03486028 | Completed

• 1 other identifier: 0216289
• Study Type: observational
• Target: 991
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use Disorders

Keywords

Patient-Centered Outcomes Research Institute (PCORI); American Society of Addiction Medicine (ASAM); substance use; addiction; treatment; RTI International; UCLA

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Treatment setting used at treatment initiation

  Up to one year

• Treatment option communication

  Up to one year

Study Arms (3)

ASAM Counties/non-computerized

Pre- and 1115-waived counties that are implementing the ASAM. Intervention is adherence to ASAM protocols.

Other: Adherence to ASAM protocols

ASAM Counties/computerized

Counties using a computerized system to assist in intervention determination according to ASAM protocols. Intervention is adherence to ASAM protocols.

Other: Adherence to ASAM protocols

Non-ASAM Counties

Pre- and non-waived "control" counties that are not implementing the ASAM. Intervention is non-adherence to ASAM protocols.

Other: Non-adherence to ASAM protocols

Interventions

Adherence to ASAM protocols OTHER

ASAM Counties. These counties are requiring their providers to use ASAM criteria to assess patients and to determine level of care. These counties also use ASAM to determine the ongoing need for high-intensity services, such as residential, and approve those services for Medicaid payment.

ASAM Counties/computerized; ASAM Counties/non-computerized

Non-adherence to ASAM protocols OTHER

These counties are not implementing the ASAM criteria to assess patients and determine the level of care.

Non-ASAM Counties

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals age 19 or older receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries.

You may qualify if:

• Individuals age 19 or older
• Receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries.

You may not qualify if:

• Less than 19 years old
• Not receiving treatment for addiction in specialty addiction treatment programs licensed in California
• Not Medicaid beneficiaries

Sponsors & Collaborators

• RTI International: lead
• University of California Integrated Substance Abuse Programs: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Tami Mark, PhD, MBA

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 3, 2018
• Study Start: July 31, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 27, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)