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

NCT06249542 | Completed

• 1 other identifier: 5R01DA047312
• Study Type: interventional
• Target: 363,936
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Between 1 and 12 months per year

Secondary Outcomes (7)

• Rate of new diagnosis of drug use disorders, all drug types combined

  Between 1 and 12 months per year

• Rate of new diagnosis of opioid use disorders

  Between 1 and 12 months per year

• Rate of new diagnosis of cannabis use disorders

  Between 1 and 12 months per year

• Rate of new diagnosis of other drug use disorders

  Between 1 and 12 months per year

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

  Between 1 and 12 months per year

Study Arms (2)

Care Delivery Improvement Intervention

EXPERIMENTAL

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.

Other: Care Delivery Improvement Intervention

Usual Care

NO INTERVENTION

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.

Interventions

Care Delivery Improvement Intervention 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

Care Delivery Improvement Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Drug Abuse (NIDA): collaborator

Related Publications (2)

• 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.

  PMID: 30081930 BACKGROUND

• 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.

  PMID: 28885557 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse; Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• David S Carrell, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: February 8, 2024
• Study Start: January 1, 2015
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share