Trial Outcomes & Findings for Sustaining Patient-centered Alcohol-related Care (NCT NCT02675777)

Last Updated: 2024-12-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

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.

Results posted on

2024-12-24

Participant Flow

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.

Unit of analysis: sites

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.	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.
Usual Care STARTED	27543 3	34989 3	39357 3	75377 3	35287 3	41503 2	31248 2
Usual Care COMPLETED	27543 3	34989 3	39357 3	75377 3	35287 3	41503 2	31248 2
Usual Care NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Quality Improvement Intervention STARTED	23888 3	20146 3	17973 3	23917 3	8837 3	6345 2	2226 2
Quality Improvement Intervention COMPLETED	23888 3	20146 3	17973 3	23917 3	8837 3	6345 2	2226 2
Quality Improvement Intervention NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The populations overlap, so we separated by arm.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. Quality improvement (SPARC) 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. Quality Improvement (SPARC) 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: 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)	Usual Care Period n=255789 Participants 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).
Brief Alcohol Counseling Rate	57 participants per 10,000 with visits	11 participants per 10,000 with visits

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. Quality improvement (SPARC) 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. Quality Improvement (SPARC) 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: 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)	Usual Care Period n=255789 Participants 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).
HEDIS Defined Initiation and Engagement in Care for Alcohol Use Disorders	1.4 participants per 10,000 with visits	1.8 participants per 10,000 with visits

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. Quality improvement (SPARC) 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. Quality Improvement (SPARC) 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: 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)	Usual Care Period n=255789 Participants 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).
Alcohol Screening Rate	8320 participants per 10,000 with visits	2080 participants per 10,000 with visits

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. Quality improvement (SPARC) 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. Quality Improvement (SPARC) 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: 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)	Usual Care Period n=255789 Participants 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).
AUD Assessment Rate	80.9 participants per 10,000 with visits	4.1 participants per 10,000 with visits

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. Quality improvement (SPARC) 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. Quality Improvement (SPARC) 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: 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)	Usual Care Period n=255789 Participants 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).
Rate of (New) Diagnosis of Alcohol Use Disorders	33.8 participants per 10,000 with visits	28.8 participants per 10,000 with visits

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention. Quality improvement (SPARC) 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. Quality Improvement (SPARC) 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: 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)	Usual Care Period n=255789 Participants 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).
AUD Treatment Initiation	7.8 participants per 10,000 with visits	6.2 participants per 10,000 with visits

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Quality Improvement (SPARC) Intervention Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katharine Bradley, MD, MPH

Kaiser Permanente Washington Health Research Institute

Phone: 206-948-1933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Quality Improvement (SPARC) Intervention Period n=228258 Participants Primary care patients with visits to clinics during months after the clinic was randomly assigned to launch the quality improvement (SPARC) intervention.	Usual Care Period n=255789 Participants Primary care patients with visits to clinics during months before the clinic was randomly assigned to launch the quality improvement (SPARC) intervention.	Total n=484047 Participants Total of all reporting groups
Age, Continuous SPARC Intervention Period	50.20 years STANDARD_DEVIATION 18.09 • n=228258 Participants • The populations overlap, so we separated by arm.	—	NA years STANDARD_DEVIATION NA • n=228258 Participants • The populations overlap, so we separated by arm.
Age, Continuous Usual Care Period	—	49.30 years STANDARD_DEVIATION 18.10 • n=255789 Participants • The populations overlap, so we separated by arm.	NA years STANDARD_DEVIATION NA • n=255789 Participants • The populations overlap, so we separated by arm.
Sex/Gender, Customized Female - SPARC	135426 participants n=228258 Participants • The populations overlap, so we separated by arm.	—	135426 participants n=228258 Participants • The populations overlap, so we separated by arm.
Sex/Gender, Customized Female - Usual	—	149557 participants n=255789 Participants • The populations overlap, so we separated by arm.	149557 participants n=255789 Participants • The populations overlap, so we separated by arm.
Sex/Gender, Customized Male - SPARC	92830 participants n=228258 Participants • The populations overlap, so we separated by arm.	—	92830 participants n=228258 Participants • The populations overlap, so we separated by arm.
Sex/Gender, Customized Male - Usual Care	—	106231 participants n=255789 Participants • The populations overlap, so we separated by arm.	106231 participants n=255789 Participants • The populations overlap, so we separated by arm.
Sex/Gender, Customized Unknown - SPARC	2 participants n=228258 Participants • The populations overlap, so we separated by arm.	—	2 participants n=228258 Participants • The populations overlap, so we separated by arm.
Sex/Gender, Customized Unknown - Usual Care	—	1 participants n=255789 Participants • The populations overlap, so we separated by arm.	1 participants n=255789 Participants • The populations overlap, so we separated by arm.
Ethnicity (NIH/OMB) SPARC Period · Hispanic or Latino	13362 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	13362 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Ethnicity (NIH/OMB) SPARC Period · Not Hispanic or Latino	203201 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	203201 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Ethnicity (NIH/OMB) SPARC Period · Unknown or Not Reported	11695 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	11695 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Ethnicity (NIH/OMB) Usual Care Period · Hispanic or Latino	—	15086 Participants n=255789 Participants • The populations overlap, so we separated by arm.	15086 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Ethnicity (NIH/OMB) Usual Care Period · Not Hispanic or Latino	—	230820 Participants n=255789 Participants • The populations overlap, so we separated by arm.	230820 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Ethnicity (NIH/OMB) Usual Care Period · Unknown or Not Reported	—	9883 Participants n=255789 Participants • The populations overlap, so we separated by arm.	9883 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Asian - SPARC	24866 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	24866 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Asian - Usual Care	—	24806 Participants n=255789 Participants • The populations overlap, so we separated by arm.	24806 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Black or African American - SPARC	12525 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	12525 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Black or African American - Usual Care	—	14679 Participants n=255789 Participants • The populations overlap, so we separated by arm.	14679 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Hawaiian or Pacific Islander - SPARC	2346 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	2346 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Hawaiian or Pacific Islander - Usual Care	—	2783 Participants n=255789 Participants • The populations overlap, so we separated by arm.	2783 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Native American or Alaskan Native - SPARC	1635 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	1635 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Native American or Alaskan Native - Usual Care	—	2042 Participants n=255789 Participants • The populations overlap, so we separated by arm.	2042 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Multiple Race/Other - SPARC	6749 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	6749 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Multiple Race/Other - Usual Care	—	7932 Participants n=255789 Participants • The populations overlap, so we separated by arm.	7932 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Other - SPARC	8619 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	8619 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Other - Usual Care	—	9212 Participants n=255789 Participants • The populations overlap, so we separated by arm.	9212 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Unknown - SPARC	10754 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	10754 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized Unknown - Usual Care	—	9681 Participants n=255789 Participants • The populations overlap, so we separated by arm.	9681 Participants n=255789 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized White - SPARC	160764 Participants n=228258 Participants • The populations overlap, so we separated by arm.	—	160764 Participants n=228258 Participants • The populations overlap, so we separated by arm.
Race/Ethnicity, Customized White - Usual Care	—	184654 Participants n=255789 Participants • The populations overlap, so we separated by arm.	184654 Participants n=255789 Participants • The populations overlap, so we separated by arm.