Substance Use DisordersPCASTNCT03486028
Patient Centered Assessment and Substance Use Disorder Treatment Study (PCAST)
An observational study of Substance Use Disorders, run by RTI International at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Adherence to ASAM protocols and Non-adherence to ASAM protocols
- How many people
- 991 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 27 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals age 19 or older receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries.
Who may be able to join
- Individuals age 19 or older
- Receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries.
Who cannot join
- Less than 19 years old
- Not receiving treatment for addiction in specialty addiction treatment programs licensed in California
- Not Medicaid beneficiaries
Trial locations and contacts
1 site in 1 country.
United States1 site
RTI International
Research Triangle Park, North Carolina, 27709
About this study
Official title: Comparative Study Effectiveness of Clinical Decision-Making Processes Required by Public Health Systems Study
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
- Being tested
- Adherence to ASAM protocols, Non-adherence to ASAM protocols
- Keywords
- Patient-Centered Outcomes Research Institute (PCORI), American Society of Addiction Medicine (ASAM), substance use, addiction, treatment, RTI International, UCLA
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to ASAM protocolsOther
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.
Non-adherence to ASAM protocolsOther
These counties are not implementing the ASAM criteria to assess patients and determine the level of care.
| Study group | Role | What they receive |
|---|---|---|
| ASAM Counties/non-computerized | Pre- and 1115-waived counties that are implementing the ASAM. Intervention is adherence to ASAM protocols. Receives: 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. Receives: 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. Receives: Other: Non-adherence to ASAM protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to one year
Secondary outcomes (2)
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.
Measured: Up to one year
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start31 Jul 2018
- Primary completion1 Sep 2019
- Study completion27 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 991 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of California Integrated Substance Abuse Programs, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Tami Mark, PhD, MBA, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486028
- Sponsor's protocol ID
- 0216289
- Acronym
- PCAST
- Status last verified
- Nov 2019
- First submitted
- 26 Mar 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Effectiveness of Clinical Decision-Making Processes Required by Public Health Systems Study
- ClinicalTrials.gov ID
- NCT03486028
- Acronym / sponsor ID
- PCAST / 0216289
- Conditions
- Substance Use Disorders
- Keywords
- Patient-Centered Outcomes Research Institute (PCORI), American Society of Addiction Medicine (ASAM), substance use, addiction, treatment, RTI International, UCLA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 991 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of California Integrated Substance Abuse Programs, Patient-Centered Outcomes Research Institute
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 27 Oct 2019 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASAM Counties/non-computerized | – | Other: Adherence to ASAM protocolsPre- and 1115-waived counties that are implementing the ASAM. Intervention is adherence to ASAM protocols. |
| ASAM Counties/computerized | – | Other: Adherence to ASAM protocolsCounties using a computerized system to assist in intervention determination according to ASAM protocols. Intervention is adherence to ASAM protocols. |
| Non-ASAM Counties | – | Other: Non-adherence to ASAM protocolsPre- and non-waived "control" counties that are not implementing the ASAM. Intervention is non-adherence to ASAM protocols. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals age 19 or older receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries.
Key inclusion criteria (2 listed)
- Individuals age 19 or older
- Receiving treatment for addiction in specialty addiction treatment programs licensed in California who are Medicaid beneficiaries.
Key exclusion criteria (3 listed)
- Less than 19 years old
- Not receiving treatment for addiction in specialty addiction treatment programs licensed in California
- Not Medicaid beneficiaries
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 |
|---|---|---|
| Adherence to ASAM protocolsASAM 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. | Other | ASAM Counties/computerized, ASAM Counties/non-computerized |
| Non-adherence to ASAM protocolsThese counties are not implementing the ASAM criteria to assess patients and determine the level of care. | Other | Non-ASAM Counties |
Primary outcome
Treatment Retention
Time frame: Up to one year
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.
Substance Use Reduction
Time frame: Up to one year
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.
2 secondary outcomes
Treatment setting used at treatment initiation
Time frame: Up to one year
Treatment option communication
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Tami Mark, PhD, MBA principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by RTI International at 1 site 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 2 inclusion and 3 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Retention (time frame: Up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2019.