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Cannabis-Related DisorderNCT06249542

Implementing Screening for Cannabis and Other Drug Use Disorders in Primary Care: Impact on Diagnosis and Treatment

A study testing Care Delivery Improvement Intervention in people with Cannabis-Related Disorder and Cannabis Abuse, run by Kaiser Permanente.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our proposed evaluation study is designed to evaluate the impact of a recently completed stepped wedge cluster randomized trial, conducted at Kaiser Permanente Washington (KPWA), of an intervention to improve care and management of patients with drug use disorders (DUDs) in primary care (Aim 1). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Care Delivery Improvement Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363,936 participants
Where
No sites listed yet
Study dates
Jan 2015to 31 Jul 2024
Phase
Interventional
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Kaiser Permanente Washington health plan enrollees, AND
  • Age 18 years and older, AND
  • Completes one or more encounters in any study clinic during the study period

Who cannot join

  • None

About this study

Official title: Implementing Routine Screening for Cannabis and Other Drug Use Disorders in Primary Care: Impact on Diagnosis and Treatment in a Randomized Pragmatic Trial in 22 Clinics

Our proposed evaluation study is designed to evaluate the impact of a recently completed stepped wedge cluster randomized trial, conducted at Kaiser Permanente Washington (KPWA), of an intervention to improve care and management of patients with drug use disorders (DUDs) in primary care (Aim 1). We will also explore the reasons for any apparent gaps in DUD care by analyzing clinicians' free-text encounter notes using manual chart review, natural language processing (NLP), and/or NLP-assisted manual chart review, as appropriate (Aim 2).

Specific Project Aims are as follows:

Read more

Aim 1 The primary research question we address in Aim 1 is whether routine screening for drug use disorders in primary care (PC) settings increases DUD treatment. We define DUDs as including opioid use disorders (OUD), cannabis use disorders (CUD), and other non-alcohol drug use disorders (OTH). Previously published analyses indicate that the 22 PC clinics in this trial sustained very high rates of screening (88%) and a 3-clinic DUD pilot study suggested that this screening resulted in increased diagnosis of CUD and increased treatment of DUDs in general, even at relatively low observed rates of PC-based screening and assessment.

Aim 2

The overall goal of Aim 2 is to expand our understanding of gaps in DUD diagnosis and treatment that persist-despite implementation of high rates of PC screening and assessment for SUDs-using rich information available only in free-text chart notes. Through analysis of relevant chart notes Aim 2 of this project will descriptively characterize gaps in DUD diagnosis and DUD treatment (i.e., instances where information in a patient's record suggests a DUD could be diagnosed but no diagnosis is present, or a new diagnosis suggest treatment is indicated but no evidence of treatment is present), and characterize reasons for DUD care gaps.

Read the detailed description

Prior to 2015, KPWA's Behavioral Health Service (BHS) leaders decided to implement an intervention to improve the quality of population-based primary care of several behavioral health conditions including depression and unhealthy use of alcohol, opioids, cannabis, and other drugs. Additionally, these leaders decided to transition primary care social workers to become integrated behavioral health clinicians in 2015.

Pilot testing of quality improvement implementation strategies in 2015 was led by BHS leaders in collaboration with other KPWA departments. State-of-the-art implementation methods were used to integrate evidence-based alcohol-related care into 3 pilot primary care clinics. Implementation strategies included: participatory design, clinical champions, practice facilitation, performance monitoring and feedback, and clinical decision support in the electronic health record (EHR). To encourage care team members to routinely engage patients in discussions of unhealthy substance use while avoiding stigmatized language, a video and informational handout was designed and used in an effort to shift caregiver attitudes and practices. Screening and follow-up assessment for symptoms of all substance use disorders are conducted on paper and entered into the KPWA Epic EHR by medical assistants. The implementation strategy was refined through the use of ongoing formative evaluation.

Timing of the implementation of the quality improvement intervention was staggered to 1) allow adequate support of care teams by available care practice facilitators, and 2) facilitate rigorous evaluation of the impact on patient care of implementing the intervention using secondary quality improvement data.

Research teams at Kaiser Permanente Washington Health Research Institute (KPWHRI) supported the implementation effort and have lead or are leading various components of the evaluation. All evaluations are based on a pragmatic stepped-wedge quality improvement randomized trial design for 22 KPWA clinics. Three pairs of these clinics were combined for purposes of implementation and evaluation, resulting in a set of 19 implementation "sites." Implementation was staggered in 7 waves over a three-year period, with each wave including 2 or 3 sites (3 waves in the first year and 4 waves in each of the second and third years). Randomization was also stratified by year. For pragmatic reasons, KPWA clinical leaders designated 9 clinics that were randomized in the first year (as 9 sites). The remaining 13 clinics were randomized in the second and third years (as 10 sites).

The implementation period in each clinic lasted 4 months.

Our definitions of drug use disorder treatment are modified versions of definitions published in the Healthcare Effectiveness Data and Information Set (HEDIS).

Being tested
Care Delivery Improvement Intervention
Medical subject headings
Marijuana Abuse, Substance-Related Disorders, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care Delivery Improvement InterventionOther

    KPWA clinical leaders and clinicians in each clinic implemented all aspects of the care delivery improvement intervention, including screening, assessment, and shared decision-making followed, as appropriate, by treatment. The implementation strategy, which was refined during the pilot phase, included:

    1. Identification of a clinical champion and local implementation team
    2. Participatory design
    3. Training of primary care providers and medical assistants
    4. Use of EHR clinical decision support tools
    5. Weekly facilitated local implementation team meetings
    6. Performance monitoring with feedback, including monthly meetings with the local implementation team and clinic leaders
    7. Learning sessions for primary care providers during implementation
    8. Social worker use of an EHR registry with weekly supervision
    9. Use of a video and informational handouts to shift attitudes and reduce stigma associated with unhealthy substance use
Study groups in NCT06249542
Study groupRoleWhat they receive
Care Delivery Improvement InterventionExperimentalThe care delivery improvement intervention consisted of a period of 4 months during which practice facilitators supported each clinic in implementing routine, population-based screening, assessment, treatment, and follow-up for depression and unhealthy substance use and substance use disorders.
Receives: Other: Care Delivery Improvement Intervention
Usual CareNo interventionUsual care consisted of care received in a study clinic after January 1, 2015 and prior to active implementation of the quality improvement intervention in that clinic. The usual care period included 1) a two-month pre-intervention preparatory period during which EHR tools designed to support the intervention had been activated in the EHR and were available to clinic staff but had not yet been actively promoted by practice facilitators (a condition the investigators refer to as "passive access"), and 2) a two-month preparation period during which practice facilitators, who were not members of the local clinic staff, engaged clinic staff in team building exercises and pretesting of the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of new drug use disorder treatment using modified HEDIS criteria.

    A patient has a new episode of treatment for a drug use disorder when: 1) they receive a new diagnosis (i.e., a disorder diagnosis preceded by 365 days without a diagnosis of the same type) for a specific disorder type--OUD, CUD, or OTH, 2) they initiate drug use disorder treatment, defined as evidence of a 2nd encounter coded with the same type of disorder diagnosis 1-14 days following the above defined new diagnosis, and 3) they engage in drug use disorder treatment, defined as two additional encounters coded with diagnoses of the same type of disorder 1-29 days after meeting the above treatment initiation criterion. Each patient may contributed between one month and 12 months per calendar year, including all months in which they have at least one study clinic encounter. The outcome rate is calculated per study clinic per month as the number of patients meeting this outcome definition per 10,000 patients with study clinic encounters.

    Measured: Between 1 and 12 months per year

Secondary outcomes (7)
  1. Rate of new diagnosis of drug use disorders, all drug types combined

    Rates of new diagnoses of drug use disorders are defined operationally as the presence of an encounter in a study clinic coded with a drug use disorder diagnosis not preceded by an encounter during the prior 365 days in any setting coded with a drug use disorder diagnosis of the same type (i.e., OUD, CUD, or OTH).

    Measured: Between 1 and 12 months per year

  2. Rate of new diagnosis of opioid use disorders

    Rates of new diagnoses of opioid use disorders are defined operationally as the presence of an encounter in a study clinic coded with an opioid use disorder diagnosis not preceded by an encounter during the prior 365 days in any setting coded with an opioid use disorder diagnosis.

    Measured: Between 1 and 12 months per year

  3. Rate of new diagnosis of cannabis use disorders

    Rates of new diagnoses of cannabis use disorders are defined operationally as the presence of an encounter in a study clinic coded with a cannabis use disorder diagnosis not preceded by an encounter during the prior 365 days in any setting coded with a cannabis use disorder diagnosis.

    Measured: Between 1 and 12 months per year

  4. Rate of new diagnosis of other drug use disorders

    Rates of new diagnoses of other drug use disorders are defined operationally as the presence of an encounter in a study clinic coded with an other drug use disorder diagnosis (which includes disorders involving any substances other than opioids, cannabis, and alcohol) not preceded by an encounter during the prior 365 days in any setting coded with an other drug use disorder diagnosis.

    Measured: Between 1 and 12 months per year

  5. Rate of opioid use disorder treatment using a modified HEDIS operational definition.

    A patient has this outcome when: 1) they receive a new diagnosis (i.e., a disorder diagnosis preceded by 365 days without a diagnosis of the same type) for opioid use disorder, 2) they initiate opioid use disorder treatment, defined as evidence of a 2nd encounter coded with an opioid use disorder diagnosis 1-14 days following the above defined new diagnosis, and 3) they engage in opioid use disorder treatment, defined as two additional encounters coded with opioid use disorder diagnoses 1-29 days after meeting the above defined treatment initiation criterion. Each patient may contributed between one month and 12 months per calendar year, including all months in which they have at least one study clinic encounter. The outcome rate is calculated per study clinic per month as the number of patients meeting this outcome definition per 10,000 patients with study clinic encounters.

    Measured: Between 1 and 12 months per year

  6. Rate of cannabis use disorder treatment using a modified HEDIS operational definition

    A patient has this outcome when: 1) they receive a new diagnosis (i.e., a disorder diagnosis preceded by 365 days without a diagnosis of the same type) for cannabis use disorder, 2) they initiate cannabis use disorder treatment, defined as evidence of a 2nd encounter coded with a cannabis use disorder diagnosis 1-14 days following the above defined new diagnosis, and 3) they engage in cannabis use disorder treatment, defined as two additional encounters coded with cannabis use disorder diagnoses 1-29 days after meeting the above defined treatment initiation criterion. Each patient may contributed between one month and 12 months per calendar year, including all months in which they have at least one study clinic encounter. The outcome rate is calculated per study clinic per month as the number of patients meeting this outcome definition per 10,000 patients with study clinic encounters.

    Measured: Between 1 and 12 months per year

  7. Rate of other drug use disorder treatment using a modified HEDIS operational definition

    A patient has this outcome when: 1) they receive a new diagnosis for an other drug use disorder (i.e., disorders involving any substance type other than opioids, cannabis, and alcohol) preceded by 365 days without a diagnosis of the same type, 2) they initiate other drug use disorder treatment, defined as evidence of a 2nd encounter coded with an other drug use disorder diagnosis 1-14 days following the above defined new diagnosis, and 3) they engage in other drug use disorder treatment, defined as two additional encounters coded with other drug use disorder diagnoses 1-29 days after meeting the above defined treatment initiation criterion. Each patient may contributed between one month and 12 months per calendar year, including all months in which they have at least one study clinic encounter. The outcome rate is calculated per study clinic per month as the number of patients meeting this outcome definition per 10,000 patients with study clinic encounters.

    Measured: Between 1 and 12 months per year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study startJan 2015
  3. Primary completion30 Apr 2024
  4. Study completion31 Jul 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
363,936 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249542
Sponsor's protocol ID
5R01DA047312
Other IDs
5R01DA047312
Status last verified
Oct 2024
First submitted
20 Jul 2023
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Glass JE, Bobb JF, Lee AK, Richards JE, Lapham GT, Ludman E, Achtmeyer C, Caldeiro RM, Parrish R, Williams EC, Lozano P, Bradley KA. Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial). Implement Sci. 2018 Aug 6;13(1):108. doi: 10.1186/s13012-018-0795-9.

    PubMed 30081930
  • Bobb JF, Lee AK, Lapham GT, Oliver M, Ludman E, Achtmeyer C, Parrish R, Caldeiro RM, Lozano P, Richards JE, Bradley KA. Evaluation of a Pilot Implementation to Integrate Alcohol-Related Care within Primary Care. Int J Environ Res Public Health. 2017 Sep 8;14(9):1030. doi: 10.3390/ijerph14091030.

    PubMed 28885557
  • Matson TE, Johnson E, Bobb JF, Graham VF, Kiel LM, Lee AK, Lapham GT, Caldeiro RM, Bradley KA, Angerhofer JE. Implementing Care for Cannabis and Other Drug Use in Adult Primary Care: Outcomes of a Cluster-Randomized Implementation Trial. Am J Prev Med. 2026 Jan;70(1):108112. doi: 10.1016/j.amepre.2025.108112. Epub 2025 Sep 16.

    PubMed 40967380

Questions about this trial

What is this clinical trial studying?

A study testing Care Delivery Improvement Intervention in people with Cannabis-Related Disorder and Cannabis Abuse, run by Kaiser Permanente.

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 3 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Rate of new drug use disorder treatment using modified HEDIS criteria. (time frame: Between 1 and 12 months per year). 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 NCT06249542, which also lists 3 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 1 Nov 2024.

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