An interventional study of Quality Improvement Intervention in Alcohol, Drinking and Alcohol Use Disorder, sponsored by Kaiser Permanente. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Other
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:
Secondary outcomes will include:
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.
940 studies on the registry are indexed under Alcohol Drinking; 169 are open to participants now.
This study's enrollment of 19 is below the median of 108 across 813 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Kaiser Permanente is the lead sponsor of 392 studies on the registry; 42 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Inclusion Criteria:
Exclusion Criteria: None
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
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).
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)
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.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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
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.
Time frame: 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.
Rate of (New) Diagnosis of Alcohol Use Disorders
New AUD diagnosis meant that International Classification of Diseases, Ninth or Tenth Revision (ICD-9/ICD-10) code for an AUD documented at the visit and no AUD diagnosis in prior year.
Time frame: 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
AUD treatment initiation meant that a new AUD diagnosis was documented at a visit and treatment was documented in a separate visit on the day of diagnosis or within 14 days after the visit (see article text for definition of treatment).
Time frame: 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.
Time frame: 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.
| Milestone | Wave 1 | Wave 2 | Wave 3 | Wave 4 | Wave 5 | Wave 6 | Wave 7 |
|---|---|---|---|---|---|---|---|
| Started | 27543 | 34989 | 39357 | 75377 | 35287 | 41503 | 31248 |
| Completed | 27543 | 34989 | 39357 | 75377 | 35287 | 41503 | 31248 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Wave 1 | Wave 2 | Wave 3 | Wave 4 | Wave 5 | Wave 6 | Wave 7 |
|---|---|---|---|---|---|---|---|
| Started | 23888 | 20146 | 17973 | 23917 | 8837 | 6345 | 2226 |
| Completed | 23888 | 20146 | 17973 | 23917 | 8837 | 6345 | 2226 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| participants per 10,000 with visits | Quality Improvement (SPARC) Intervention Period | Usual Care Period |
|---|---|---|
| Brief Alcohol Counseling Rate | 57 | 11 |
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.
| participants per 10,000 with visits | Quality Improvement (SPARC) Intervention Period | Usual Care Period |
|---|---|---|
| HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders | 1.4 | 1.8 |
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.
| participants per 10,000 with visits | Quality Improvement (SPARC) Intervention Period | Usual Care Period |
|---|---|---|
| Alcohol Screening Rate | 8320 | 2080 |
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.
| participants per 10,000 with visits | Quality Improvement (SPARC) Intervention Period | Usual Care Period |
|---|---|---|
| AUD Assessment Rate | 80.9 | 4.1 |
New AUD diagnosis meant that International Classification of Diseases, Ninth or Tenth Revision (ICD-9/ICD-10) code for an AUD documented at the visit and no AUD diagnosis in prior year.
| participants per 10,000 with visits | Quality Improvement (SPARC) Intervention Period | Usual Care Period |
|---|---|---|
| Rate of (New) Diagnosis of Alcohol Use Disorders | 33.8 | 28.8 |
AUD treatment initiation meant that a new AUD diagnosis was documented at a visit and treatment was documented in a separate visit on the day of diagnosis or within 14 days after the visit (see article text for definition of treatment).
| participants per 10,000 with visits | Quality Improvement (SPARC) Intervention Period | Usual Care Period |
|---|---|---|
| AUD Treatment Initiation | 7.8 | 6.2 |
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.
Results for this outcome have not been posted.
Collected over N/A, adverse events were not collected for this pragmatic quality improvement implementation trial. All clinical care was under the purview of the health system.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quality Improvement (SPARC) Intervention Period | — | — | — |
| Usual Care Period | — | — | — |
Patients could have a visit in both periods (total number of patients with a visit = 333,596; number of patients with visits in both periods = 150,451).
| Age, Continuous(years) | Quality Improvement (SPARC) Intervention Period | Usual Care Period | Total |
|---|---|---|---|
| SPARC Intervention Period | 50.20 ± 18.09 | — | NA ± NA |
| Usual Care Period | — | 49.30 ± 18.10 | NA ± NA |
| Sex/Gender, Customized(participants) | Quality Improvement (SPARC) Intervention Period | Usual Care Period | Total |
|---|---|---|---|
| Female - SPARC | 135426 | — | 135426 |
| Female - Usual | — | 149557 | 149557 |
| Male - SPARC | 92830 | — | 92830 |
| Male - Usual Care | — | 106231 | 106231 |
| Unknown - SPARC | 2 | — | 2 |
| Unknown - Usual Care | — | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Quality Improvement (SPARC) Intervention Period | Usual Care Period | Total |
|---|---|---|---|
| SPARC Period — Hispanic or Latino | 13362 | — | 13362 |
| SPARC Period — Not Hispanic or Latino | 203201 | — | 203201 |
| SPARC Period — Unknown or Not Reported | 11695 | — | 11695 |
| Usual Care Period — Hispanic or Latino | — | 15086 | 15086 |
| Usual Care Period — Not Hispanic or Latino | — | 230820 | 230820 |
| Usual Care Period — Unknown or Not Reported | — | 9883 | 9883 |
| Race/Ethnicity, Customized(Participants) | Quality Improvement (SPARC) Intervention Period | Usual Care Period | Total |
|---|---|---|---|
| Asian - SPARC | 24866 | — | 24866 |
| Asian - Usual Care | — | 24806 | 24806 |
| Black or African American - SPARC | 12525 | — | 12525 |
| Black or African American - Usual Care | — | 14679 | 14679 |
| Hawaiian or Pacific Islander - SPARC | 2346 | — | 2346 |
| Hawaiian or Pacific Islander - Usual Care | — | 2783 | 2783 |
| Native American or Alaskan Native - SPARC | 1635 | — | 1635 |
| Native American or Alaskan Native - Usual Care | — | 2042 | 2042 |
| Multiple Race/Other - SPARC | 6749 | — | 6749 |
| Multiple Race/Other - Usual Care | — | 7932 | 7932 |
| Other - SPARC | 8619 | — | 8619 |
| Other - Usual Care | — | 9212 | 9212 |
| Unknown - SPARC | 10754 | — | 10754 |
| Unknown - Usual Care | — | 9681 | 9681 |
| White - SPARC | 160764 | — | 160764 |
| White - Usual Care | — | 184654 | 184654 |
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