Clinical trial NCT02675777: Sustaining Patient-centered Alcohol-related Care
Official title: Sustained Implementation of Patient-Centered Care for Alcohol Misuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol, Drinking
Alcohol Use Disorder
Keywords: Alcohol misuse
Unhealthy alcohol use
Alcoholism
Alcohol dependence
Alcohol abuse
Risky drinking
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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. The proportion of patients who have primary care visits who screen positive for unhealthy alcohol use and have documented annual brief alcohol counseling;
2. The proportion of patients who have primary care visits who have AUDs identified, and a) initiate and b) engage in care for AUDs.

Secondary outcomes will include:

1. The proportion of patients who have primary care visits who have documented annual alcohol screening with the AUDIT-C; and
2. The proportion of patients who have primary care visits who screen positive for severe unhealthy alcohol use and have AUDs assessed and/or diagnosed;

Detailed description: Group Health's Behavioral Health Service leaders decided to implement alcohol-related care along with integration of population-based primary care for other behavioral health conditions, including screening for depression, marijuana and other substance use and use disorders. Group Health leaders also decided to transition primary care social workers to become integrated behavioral health clinicians in 2015.

Pilot testing of the implementation strategies in 2015 was led by Group Health's Behavioral Health Service (BHS) in collaboration with other Group Health departments. State-of-the-art implementation methods were used to integrate evidence-based alcohol-related care into 3 pilot primary care clinics in Group Health. The implementation strategies included: participatory design, clinical champions, practice facilitation, performance monitoring and feedback, and clinical decision support in the electronic health record (EHR). The implementation strategies also included a video and handout designed explicitly to shift staff attitudes, in order to make discussions of unhealthy alcohol use routine and less stigmatized in primary care. Screening and follow-up assessment for symptoms of AUDs are conducted on paper and then typically entered into the EPIC EHR by medical assistants (MAs). The implementation strategy was refined based on ongoing formative evaluation.

Group Health leaders are now prepared to roll out behavioral health integration to the remaining 22 primary care clinics. All implementation will be led and conducted by Group Health clinical leaders and clinicians. The timing of implementation at the 22 clinics is staggered to allow for support from practice facilitators. Leaders randomized clinics to different start dates to allow a rigorous evaluation using secondary quality improvement data.

The research team at Group Health Research Institute is supporting implementation and will lead the evaluation. The research team will conduct a pragmatic stepped-wedge quality improvement trial in the 22 primary care clinics. Implementation will be staggered in 7 waves, each of which will be 4 months long (3 waves in Year 1; 4 waves in Years 2-3). Randomization is stratified by study Year, with 9 sites chosen by Group Health clinical leaders to start in Year 1, and the 13 remaining sites to be randomized in Year 2. Randomization is stratified primarily because Group Health clinical leaders wanted to choose the first 9 clinics. In addition, they may decide remove 3 or 4 facilities in Spokane (a long distance from Seattle requiring air travel) from the Year 2 randomization (thereby omitting 1 of the 7 waves of implementation Year 2).

Due to the pragmatic nature of this trial, clinical partners requested some modifications to the trial design. Please see the study pilot results, protocol paper, and main results paper for details. Of note, the 22 practices were randomized as 19 "sites" because clinical leaders requested that three pairs of nearby practices be randomized together as 3 sites.

Eligibility criteria: Inclusion Criteria:

1. Group Health group practice patients, AND
2. Age 18 years and older, AND
3. 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.

Exclusion Criteria: None

Primary outcomes:
measure: Brief Alcohol Counseling Rate
timeFrame: 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.
measure: HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders
timeFrame: 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:
measure: Alcohol Screening Rate
timeFrame: 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
measure: AUD Assessment Rate
timeFrame: 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:
measure: Rate of (New) Diagnosis of Alcohol Use Disorders
timeFrame: 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.
measure: AUD Treatment Initiation
timeFrame: 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.
measure: Maintenance of Alcohol-related Care
timeFrame: 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.
Locations:
Study officials:
affiliation: Group Health Research Institute
name: Katharine Bradley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.