Sustaining Patient-centered Alcohol-related Care

Alcohol Use Disorder Clinical Trial

— SPARC  

Official title:

Sustained Implementation of Patient-Centered Care for Alcohol Misuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675777
• Other study ID #: AHRQ-R18-HS023173
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: September 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433111
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol, Drinking
• Alcoholism

Intervention

Other:
• Quality Improvement Intervention
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: Identification of a clinical champion and Local Implementation Team. Participatory Design. Training primary care providers and Medical Assistants. EHR clinical decision support tools Weekly facilitated Local Implementation Team meetings. Performance monitoring with feedback, including monthly PDCA meetings with the Local Implementation Team and clinic leaders. Learning sessions for primary care providers during implementation. Social worker use of an EHR registry with weekly supervision. Video and handout explicitly designed to shift attitudes about unhealthy alcohol use (overcoming misconceptions and stigma)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

References & Publications (2)

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). pii: E1030. doi: 10.3390/ijerph14091030. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Diagnosis of Alcohol Use Disorders	Among patients who have primary care visits, the proportion who are diagnosed with AUDs on the day of the visit or in the past year.	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.
Other	Engagement in Care for New Alcohol Use Disorders within 30 Days	Among patients who have at least one primary care visit, the proportion who are diagnosed with a new AUD (no AUD diagnosis in the past 365 days) and also have a telephone or in-person visit for AUD or a claim for care for AUD in the following 30 days.	Rates of engagement in care for AUDs in the 30 days after a new 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.
Other	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.
Primary	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.
Primary	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	Alcohol Screening Rate	Among patients who have at least one primary care visit, the proportion who have alcohol screening with the AUDIT-C documented in their EHR on the date of the visit or in the prior year.	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
Secondary	AUD Assessment Rate	Among patients who have at least one primary care visit, the proportion who screen positive for severe unhealthy alcohol use (AUDIT-C 7-12) and have assessment for AUDs, or an AUD diagnosis, documented in their EHR on the date of the visit or in the prior year.	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.