Alcohol, Drinking, Alcohol Use Disorder
Conditions
Keywords
Alcohol misuse, Unhealthy alcohol use, Alcoholism, Alcohol dependence, Alcohol abuse, Risky drinking
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.
Interventions
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)
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Alcohol Counseling Rate | 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. | 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. |
| HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| 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. | 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. |
| 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. | 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. |
Participant flow
Pre-assignment details
In this stepped wedge study, 19 sites were randomly assigned to 7 waves, which determined the time period in which they would implement the Quality Improvement Intervention. This study used an open cohort design, in which patients were analyzed during the time periods in which they had visits to a particating site. Therefore, patients could visit the site in one or both periods (i.e., before and/or after the Quality Improvement Intervention began), and also could visit sites in multiple waves.
Participants by arm
| Arm | Count |
|---|---|
| Quality Improvement (SPARC) Intervention Period Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. | 228,258 |
| Usual Care Period Primary care patients with visits to clinics during months before the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. | 255,789 |
| Total | 484,047 |
Baseline characteristics
| Characteristic | Quality Improvement (SPARC) Intervention Period | Total | Usual Care Period |
|---|---|---|---|
| Age, Continuous SPARC Intervention Period | 50.20 years STANDARD_DEVIATION 18.09 | NA years | — |
| Age, Continuous Usual Care Period | — | NA years | 49.30 years STANDARD_DEVIATION 18.1 |
| Ethnicity (NIH/OMB) SPARC Period Hispanic or Latino | 13362 Participants | 13362 Participants | — |
| Ethnicity (NIH/OMB) SPARC Period Not Hispanic or Latino | 203201 Participants | 203201 Participants | — |
| Ethnicity (NIH/OMB) SPARC Period Unknown or Not Reported | 11695 Participants | 11695 Participants | — |
| Ethnicity (NIH/OMB) Usual Care Period Hispanic or Latino | — | 15086 Participants | 15086 Participants |
| Ethnicity (NIH/OMB) Usual Care Period Not Hispanic or Latino | — | 230820 Participants | 230820 Participants |
| Ethnicity (NIH/OMB) Usual Care Period Unknown or Not Reported | — | 9883 Participants | 9883 Participants |
| Race/Ethnicity, Customized Asian - SPARC | 24866 Participants | 24866 Participants | — |
| Race/Ethnicity, Customized Asian - Usual Care | — | 24806 Participants | 24806 Participants |
| Race/Ethnicity, Customized Black or African American - SPARC | 12525 Participants | 12525 Participants | — |
| Race/Ethnicity, Customized Black or African American - Usual Care | — | 14679 Participants | 14679 Participants |
| Race/Ethnicity, Customized Hawaiian or Pacific Islander - SPARC | 2346 Participants | 2346 Participants | — |
| Race/Ethnicity, Customized Hawaiian or Pacific Islander - Usual Care | — | 2783 Participants | 2783 Participants |
| Race/Ethnicity, Customized Multiple Race/Other - SPARC | 6749 Participants | 6749 Participants | — |
| Race/Ethnicity, Customized Multiple Race/Other - Usual Care | — | 7932 Participants | 7932 Participants |
| Race/Ethnicity, Customized Native American or Alaskan Native - SPARC | 1635 Participants | 1635 Participants | — |
| Race/Ethnicity, Customized Native American or Alaskan Native - Usual Care | — | 2042 Participants | 2042 Participants |
| Race/Ethnicity, Customized Other - SPARC | 8619 Participants | 8619 Participants | — |
| Race/Ethnicity, Customized Other - Usual Care | — | 9212 Participants | 9212 Participants |
| Race/Ethnicity, Customized Unknown - SPARC | 10754 Participants | 10754 Participants | — |
| Race/Ethnicity, Customized Unknown - Usual Care | — | 9681 Participants | 9681 Participants |
| Race/Ethnicity, Customized White - SPARC | 160764 Participants | 160764 Participants | — |
| Race/Ethnicity, Customized White - Usual Care | — | 184654 Participants | 184654 Participants |
| Sex/Gender, Customized Female - SPARC | 135426 participants | 135426 participants | — |
| Sex/Gender, Customized Female - Usual | — | 149557 participants | 149557 participants |
| Sex/Gender, Customized Male - SPARC | 92830 participants | 92830 participants | — |
| Sex/Gender, Customized Male - Usual Care | — | 106231 participants | 106231 participants |
| Sex/Gender, Customized Unknown - SPARC | 2 participants | 2 participants | — |
| Sex/Gender, Customized Unknown - Usual Care | — | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quality Improvement (SPARC) Intervention Period | Brief Alcohol Counseling Rate | 57 participants per 10,000 with visits |
| Usual Care Period | Brief Alcohol Counseling Rate | 11 participants per 10,000 with visits |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quality Improvement (SPARC) Intervention Period | HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders | 1.4 participants per 10,000 with visits |
| Usual Care Period | HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders | 1.8 participants per 10,000 with visits |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quality Improvement (SPARC) Intervention Period | Alcohol Screening Rate | 8320 participants per 10,000 with visits |
| Usual Care Period | Alcohol Screening Rate | 2080 participants per 10,000 with visits |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quality Improvement (SPARC) Intervention Period | AUD Assessment Rate | 80.9 participants per 10,000 with visits |
| Usual Care Period | AUD Assessment Rate | 4.1 participants per 10,000 with visits |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quality Improvement (SPARC) Intervention Period | AUD Treatment Initiation | 7.8 participants per 10,000 with visits |
| Usual Care Period | AUD Treatment Initiation | 6.2 participants per 10,000 with visits |
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.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quality Improvement (SPARC) Intervention Period | Rate of (New) Diagnosis of Alcohol Use Disorders | 33.8 participants per 10,000 with visits |
| Usual Care Period | Rate of (New) Diagnosis of Alcohol Use Disorders | 28.8 participants per 10,000 with visits |