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

NCT ID: NCT06249542

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

363936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2024-07-31

Brief Summary

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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:

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.

Detailed Description

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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).

Conditions

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Cannabis-Related Disorder Cannabis Abuse Drug Abuse Drug Use Disorders Opioid Use Disorder Opioid Abuse Substance Abuse Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Care Delivery Improvement Intervention

The 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.

Group Type EXPERIMENTAL

Care Delivery Improvement Intervention

Intervention Type OTHER

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

Usual Care

Usual 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Care Delivery Improvement Intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David S Carrell, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

References

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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.

Reference Type BACKGROUND
PMID: 30081930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28885557 (View on PubMed)

Other Identifiers

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5R01DA047312

Identifier Type: NIH

Identifier Source: secondary_id

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5R01DA047312

Identifier Type: NIH

Identifier Source: org_study_id

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