Trial Outcomes & Findings for Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations (NCT NCT04870307)

Results Overview

Change in the proportion of patients eligible for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing based on screening that receive SARS-CoV-2 test. The proportion ranges between zero and one.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

323 participants

Primary outcome timeframe

Baseline to 12 months

Results posted on

2025-01-30

Participant Flow

Unit of analysis: Practices

Participant milestones

Participant milestones
Measure	Primary Care Practices A practice-based implementation study was conducted with 35 primary care practices, with baseline data collection, and overlapping interim measurements of care quality and process outcomes, followed by a final data collection at the end of the intervention. The practice-based approach involved assisting primary care practices to address SARS-CoV-2 testing using evidence-based practices. The intervention model included practice assessment, academic detailing, practice facilitation, health information technology support, performance feedback and benchmarking, and a virtual learning community. Practice members were surveyed to better understand barriers to SARS-CoV-2 testing. Patients were not direct subjects. The intervention targeted practices and practice members.
Overall Study STARTED	323 35
Overall Study COMPLETED	149 22
Overall Study NOT COMPLETED	174 13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age information was only collected for 179 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Care Practices n=35 Practices A practice-based implementation study was conducted with 35 practices, with baseline data collection, and overlapping with interim measurements of care quality and process outcomes, followed by a final data collection at the end of the intervention (including baseline measures plus semi-structured interviews. The practice based approach to increasing testing will be compared to a community-based approach using mobile-setting to increase testing. Additional, non-clinical trial components of this study include patient surveys to understand facilitators and barriers to SARS-CoV-2 testing and identification of legal/ethical, socioeconomic, and behavioral implications of increased testing. Patients are not direct subjects in this part of the study. Intervention will target practices and practice members. Dissemination and Implementation Research: Dissemination and Implementation research involves assisting primary care practices to address SARS-CoV-2 testing using evidence-based practices as well as increased testing in mobile-based community settings. The D\&I model also involves Practice Assessment, Academic Detailing, Practice Facilitation, Health Information Technology Support, Performance Feedback and Benchmarking, and a Virtual Learning Community.
Age, Categorical <=18 years	0 Participants n=179 Participants • Age information was only collected for 179 participants.
Age, Categorical Between 18 and 65 years	168 Participants n=179 Participants • Age information was only collected for 179 participants.
Age, Categorical >=65 years	11 Participants n=179 Participants • Age information was only collected for 179 participants.
Sex: Female, Male Female	172 Participants n=195 Participants • Information for sex (female/male) was not collected for 128 participants.
Sex: Female, Male Male	23 Participants n=195 Participants • Information for sex (female/male) was not collected for 128 participants.
Race (NIH/OMB) American Indian or Alaska Native	13 Participants n=323 Participants
Race (NIH/OMB) Asian	2 Participants n=323 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=323 Participants
Race (NIH/OMB) Black or African American	9 Participants n=323 Participants
Race (NIH/OMB) White	151 Participants n=323 Participants
Race (NIH/OMB) More than one race	23 Participants n=323 Participants
Race (NIH/OMB) Unknown or Not Reported	125 Participants n=323 Participants
Region of Enrollment United States	323 participants n=323 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: The average proportion of patients receiving a SARS-CoV-2 test at the practice-level. Data were collected at the practice level only, no participant or patient level data were collected.

Change in the proportion of patients eligible for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing based on screening that receive SARS-CoV-2 test. The proportion ranges between zero and one.

Outcome measures

Outcome measures
Measure	Primary Care Practices n=22 Practices A practice-based implementation study was conducted with 35 practices, with baseline data collection, and overlapping with interim measurements, followed by a final data collection at the end of the intervention. Patients are not direct subjects in this part of the study. The intervention targeted practices and practice members.
Change in SARS-CoV-2 Testing Rate (Practices) 12 months	1 proportion of patients (ranging 0-1) Standard Deviation 0
Change in SARS-CoV-2 Testing Rate (Practices) Baseline	0.9928 proportion of patients (ranging 0-1) Standard Deviation 0.0348

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: The proportion of SARS-CoV-2 tests conducted at each participating practice that were positive were recorded at both baseline and at 12 months. These practice-level proportions were averaged. Data were collected at the practice level only, no participant or patient level data were collected.

Change in the proportion of SARS-CoV-2 test results that are positive.