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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Inclusion Criteria:
Exclusion Criteria: None
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| Name | Affiliation | Role |
|---|---|---|
| Katharine Bradley, MD, MPH | Group Health Research Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30081930 | Background | 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. | |
| 28885557 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wave 1 | These were the sites randomized to implement the intervention in the first wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| FG001 | Wave 2 | These were the sites randomized to implement the intervention in the second wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| FG002 | Wave 3 | These were the sites randomized to implement the intervention in the third wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| FG003 | Wave 4 | These were the sites randomized to implement the intervention in the fourth wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| FG004 | Wave 5 | These were the sites randomized to implement the intervention in the fifth wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| FG005 | Wave 6 | These were the sites randomized to implement the intervention in the sixth wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| FG006 | Wave 7 | These were the sites randomized to implement the intervention in the seventh wave. The sites within each wave started in Usual Care and then implemented the Quality Improvement Intervention. Usual Care: 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). Quality Improvement Intervention: Care received after active implementation begins and before the end of the study in 7/2018. Active implementation is 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 as part of behavioral health integration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usual Care |
| |||||||||||||
| Quality Improvement Intervention |
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care Period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The populations overlap, so we separated by arm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants per 10,000 with visits | 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. |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katharine Bradley, MD, MPH | Kaiser Permanente Washington Health Research Institute | 206-948-1933 | katharine.a.bradley@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2022 | Apr 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2022 | Jan 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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|
| 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. |
| 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). | 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. | 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. |
| 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. |
| 36848119 | 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. |
| 39348695 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Primary care patients with visits to clinics during months before the clinic was randomly assigned to launch the quality improvement (SPARC) intervention.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | The populations overlap, so we separated by arm. | Number | participants |
|
| Ethnicity (NIH/OMB) | The populations overlap, so we separated by arm. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The populations overlap, so we separated by arm. | Count of Participants | Participants |
|
| OG001 | 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. 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). |
|
|
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| 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. | Posted | Number | participants per 10,000 with visits | 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. |
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| 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. | Posted | Number | participants per 10,000 with visits | 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 |
|
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| 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. | Posted | Number | participants per 10,000 with visits | 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. |
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| Other Pre-specified | 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. | Posted | Number | participants per 10,000 with visits | 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. |
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| Other Pre-specified | 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). | Posted | Number | participants per 10,000 with visits | 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. |
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| Other Pre-specified | 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. | Not Posted | 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. | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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