Sustaining Patient-centered Alcohol-related Care

NCT02675777 | Completed Results

• 1 other identifier: AHRQ-R18-HS023173
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alcohol use is the third greatest cause of disability and death for US adults. Care for unhealthy alcohol use is lacking in most primary care settings. This project will implement two types of evidence-based care for unhealthy alcohol use in the 25 primary clinics of a regional health system-Group Health (GH). These include preventive care and treatment. Preventive care consists of alcohol screening, and for patients who screen positive, brief patient-centered counseling. Treatment for alcohol use disorders includes offering shared decision making and motivational counseling designed to enhance engagement in one or more treatment options: counseling, medications, and/or specialty treatment. During a pilot phase, the research team at Group Health Research Institute partnered with Group Health leaders and front line clinicians to design, pilot test, and iteratively refine an implementation strategy in 3 Group Health primary care clinics. Objective This study uses state-of-the-art implementation strategies to integrate evidence-based alcohol-related care into 22 primary care clinics (detailed below). This study is a pragmatic stepped-wedge quality improvement trial to evaluate its impact on:

1. 1.The proportion of patients who have primary care visits who screen positive for unhealthy alcohol use and have documented annual brief alcohol counseling;
2. 2.The proportion of patients who have primary care visits who have AUDs identified, and a) initiate and b) engage in care for AUDs.
3. 3.The proportion of patients who have primary care visits who have documented annual alcohol screening with the AUDIT-C; and
4. 4.The proportion of patients who have primary care visits who screen positive for severe unhealthy alcohol use and have AUDs assessed and/or diagnosed;

Conditions

Alcohol, Drinking; Alcohol Use Disorder

Keywords

Alcohol misuse; Unhealthy alcohol use; Alcoholism; Alcohol dependence; Alcohol abuse; Risky drinking

Outcome Measures

Primary Outcomes (2)

• Brief Alcohol Counseling Rate

  Among patients who have at least one primary care visit, the proportion who screen positive for unhealthy alcohol use (3 or more points for women and 4 or more for men on the AUDIT-C) and have brief alcohol counseling documented in their EHRs in the 14 days after the screen or in the prior year.

  Rates of documented brief alcohol counseling within 14 days after a positive alcohol screen will be compared before and after "time one" (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trial.

• HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders

  Among patients who have at least one primary care visit, the proportion who are diagnosed with a new AUD and meet criteria for a) "initiation" and b) "engagement" in care for AUDs (as defined by NCQAs HEDIS measures in 2014) based on care documented in their EHRs or via claims for AUD treatment.

  Rates of initiation and engagement will be compared before and after "time one" (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trial.

Secondary Outcomes (2)

• Alcohol Screening Rate

  Assessment rates will be compared before and after "time one" (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trial

• AUD Assessment Rate

  Screening rates will be compared before and after "time one" (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trial.

Other Outcomes (3)

• Rate of (New) Diagnosis of Alcohol Use Disorders

  Rates of AUD diagnosis will be compared before and after "time one" (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trial.

• AUD Treatment Initiation

  Rates of AUD treatment initiation will be compared before and after "time one" (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trial.

• Maintenance of Alcohol-related Care

  Rates of all primary and secondary outcomes (above) will be compared before and after "time two" (T2: the end of the 4 months of active support for implementation) for the pragmatic stepped-wedge trial.

Study Arms (2)

Quality Improvement Intervention

EXPERIMENTAL

Quality improvement intervention: 4 months during which a practice facilitator supports the clinic in implementing routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs (see "Intervention") as part of behavioral health integration.

Other: Quality Improvement Intervention

Usual Care

NO INTERVENTION

Care received after 2/2016 but before active implementation begins, which includes passive access to tools in the EHR and 2 months of preparation in each clinic (team building and local pretesting by a local implementation team supported by the external practice facilitator).

Interventions

Quality Improvement Intervention OTHER

Group Health clinical leaders and clinicians implement all aspects of behavioral health integration (screening, assessment, and shared decision-making followed by treatment). The implementation strategy, which was refined during the pilot phase, will include: 1. Identification of a clinical champion and Local Implementation Team. 2. Participatory Design. 3. Training primary care providers and Medical Assistants. 4. EHR clinical decision support tools 5. Weekly facilitated Local Implementation Team meetings. 6. Performance monitoring with feedback, including monthly PDCA 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. Video and handout explicitly designed to shift attitudes about unhealthy alcohol use (overcoming misconceptions and stigma)

Quality Improvement Intervention

Eligibility Criteria

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

You may qualify if:

• Group Health group practice patients, AND
• Age 18 years and older, AND
• Have one or more visits at one or more of the randomized Group Health primary care clinics between February 1, 2016 and August 31, 2018.

Sponsors & Collaborators

• Kaiser Permanente: lead

Related Publications (4)

• 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

• Lee AK, Bobb JF, Richards JE, Achtmeyer CE, Ludman E, Oliver M, Caldeiro RM, Parrish R, Lozano PM, Lapham GT, Williams EC, Glass JE, Bradley KA. Integrating Alcohol-Related Prevention and Treatment Into Primary Care: A Cluster Randomized Implementation Trial. JAMA Intern Med. 2023 Apr 1;183(4):319-328. doi: 10.1001/jamainternmed.2022.7083.

  PMID: 36848119 BACKGROUND

• Angerhofer Richards J, Cruz M, Stewart C, Lee AK, Ryan TC, Ahmedani BK, Simon GE. Effectiveness of Integrating Suicide Care in Primary Care : Secondary Analysis of a Stepped-Wedge, Cluster Randomized Implementation Trial. Ann Intern Med. 2024 Nov;177(11):1471-1481. doi: 10.7326/M24-0024. Epub 2024 Oct 1.

  PMID: 39348695 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Katharine Bradley, MD, MPH
• Organization: Kaiser Permanente Washington Health Research Institute

katharine.a.bradley@kp.org

206-948-1933

Study Officials

• Katharine Bradley, MD, MPH

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 28, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share