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Sustaining Patient-centered Alcohol-related Care

Sustained Implementation of Patient-Centered Care for Alcohol Misuse

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02675777
Acronym
SPARC
Enrollment
19
Registered
2016-02-05
Start date
2015-01-31
Completion date
2018-08-31
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol, Drinking, Alcohol Use Disorder

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

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Brief Alcohol Counseling RateRates 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 DisordersRates 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

MeasureTime frameDescription
Alcohol Screening RateAssessment rates will be compared before and after time one (T1: the start of the 4 months of active implementation) for the pragmatic stepped-wedge trialAmong 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 RateScreening 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

MeasureTime frameDescription
AUD Treatment InitiationRates 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 CareRates 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 DisordersRates 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

ArmCount
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
Total484,047

Baseline characteristics

CharacteristicQuality Improvement (SPARC) Intervention PeriodTotalUsual Care Period
Age, Continuous
SPARC Intervention Period
50.20 years
STANDARD_DEVIATION 18.09
NA years
Age, Continuous
Usual Care Period
NA years49.30 years
STANDARD_DEVIATION 18.1
Ethnicity (NIH/OMB)
SPARC Period
Hispanic or Latino
13362 Participants13362 Participants
Ethnicity (NIH/OMB)
SPARC Period
Not Hispanic or Latino
203201 Participants203201 Participants
Ethnicity (NIH/OMB)
SPARC Period
Unknown or Not Reported
11695 Participants11695 Participants
Ethnicity (NIH/OMB)
Usual Care Period
Hispanic or Latino
15086 Participants15086 Participants
Ethnicity (NIH/OMB)
Usual Care Period
Not Hispanic or Latino
230820 Participants230820 Participants
Ethnicity (NIH/OMB)
Usual Care Period
Unknown or Not Reported
9883 Participants9883 Participants
Race/Ethnicity, Customized
Asian - SPARC
24866 Participants24866 Participants
Race/Ethnicity, Customized
Asian - Usual Care
24806 Participants24806 Participants
Race/Ethnicity, Customized
Black or African American - SPARC
12525 Participants12525 Participants
Race/Ethnicity, Customized
Black or African American - Usual Care
14679 Participants14679 Participants
Race/Ethnicity, Customized
Hawaiian or Pacific Islander - SPARC
2346 Participants2346 Participants
Race/Ethnicity, Customized
Hawaiian or Pacific Islander - Usual Care
2783 Participants2783 Participants
Race/Ethnicity, Customized
Multiple Race/Other - SPARC
6749 Participants6749 Participants
Race/Ethnicity, Customized
Multiple Race/Other - Usual Care
7932 Participants7932 Participants
Race/Ethnicity, Customized
Native American or Alaskan Native - SPARC
1635 Participants1635 Participants
Race/Ethnicity, Customized
Native American or Alaskan Native - Usual Care
2042 Participants2042 Participants
Race/Ethnicity, Customized
Other - SPARC
8619 Participants8619 Participants
Race/Ethnicity, Customized
Other - Usual Care
9212 Participants9212 Participants
Race/Ethnicity, Customized
Unknown - SPARC
10754 Participants10754 Participants
Race/Ethnicity, Customized
Unknown - Usual Care
9681 Participants9681 Participants
Race/Ethnicity, Customized
White - SPARC
160764 Participants160764 Participants
Race/Ethnicity, Customized
White - Usual Care
184654 Participants184654 Participants
Sex/Gender, Customized
Female - SPARC
135426 participants135426 participants
Sex/Gender, Customized
Female - Usual
149557 participants149557 participants
Sex/Gender, Customized
Male - SPARC
92830 participants92830 participants
Sex/Gender, Customized
Male - Usual Care
106231 participants106231 participants
Sex/Gender, Customized
Unknown - SPARC
2 participants2 participants
Sex/Gender, Customized
Unknown - Usual Care
1 participants1 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

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.

ArmMeasureValue (NUMBER)
Quality Improvement (SPARC) Intervention PeriodBrief Alcohol Counseling Rate57 participants per 10,000 with visits
Usual Care PeriodBrief Alcohol Counseling Rate11 participants per 10,000 with visits
p-value: <0.001Mixed Models Analysis
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.

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.

ArmMeasureValue (NUMBER)
Quality Improvement (SPARC) Intervention PeriodHEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders1.4 participants per 10,000 with visits
Usual Care PeriodHEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders1.8 participants per 10,000 with visits
p-value: 0.3Mixed Models Analysis
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.

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

ArmMeasureValue (NUMBER)
Quality Improvement (SPARC) Intervention PeriodAlcohol Screening Rate8320 participants per 10,000 with visits
Usual Care PeriodAlcohol Screening Rate2080 participants per 10,000 with visits
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.

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.

ArmMeasureValue (NUMBER)
Quality Improvement (SPARC) Intervention PeriodAUD Assessment Rate80.9 participants per 10,000 with visits
Usual Care PeriodAUD Assessment Rate4.1 participants per 10,000 with visits
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).

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.

ArmMeasureValue (NUMBER)
Quality Improvement (SPARC) Intervention PeriodAUD Treatment Initiation7.8 participants per 10,000 with visits
Usual Care PeriodAUD Treatment Initiation6.2 participants per 10,000 with visits
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.

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.

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.

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.

ArmMeasureValue (NUMBER)
Quality Improvement (SPARC) Intervention PeriodRate of (New) Diagnosis of Alcohol Use Disorders33.8 participants per 10,000 with visits
Usual Care PeriodRate of (New) Diagnosis of Alcohol Use Disorders28.8 participants per 10,000 with visits

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026