Trial Outcomes & Findings for Implementation of COVID-19 Testing Strategies in Community Health Centers (NCT NCT04802187)
NCT ID: NCT04802187
Last Updated: 2023-11-08
Results Overview
Acceleration of covid testing volume during covid surges, estimated as the percent change in weekly covid testing volume trend for each 10% increase in covid cases. A slope value was estimated from a segmented regression model for the entire study period, which was then used to calculate a difference between the post- and pre-implementation periods.
COMPLETED
NA
6 participants
85 weeks post-implementation compared to 35 weeks pre-implementation
2023-11-08
Participant Flow
No participants were enrolled. 6 community health centers (CHC) contributed to control and intervention groups. These 6 CHCs were on the same time sequence in the interrupted time series and are listed as one group. To include an intervention and a control group separately would inaccurately sum the total participants to 12 CHCs. 6 CHCs contributed to both analytic groups (intervention and control). The study is therefore most accurately represented by including all CHCs in the same group.
Unit of analysis: Community health center
Participant milestones
| Measure |
RADx CHCs Testing Intervention Strategy
Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs.
RADx CHCs testing intervention strategy: The study team will support partner CHCs to implement workflows with some combination of dedicated testing staff, off-site testing, outreach/communications to priority populations, and linkage with local contact tracing systems. Implementation support will take the form of practice facilitation, rapid cycle testing (by supporting CHCs to review their internal data to assess the impact of workflow changes), and expert consultation from the research team on testing technology and testing location design.
All six community health centers had the same interruption point in the interrupted time series contributing 35 pre implementation usual care weeks, 85 post implementation intervention weeks.
|
|---|---|
|
Overall Study
STARTED
|
0 6
|
|
Overall Study
COMPLETED
|
0 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of COVID-19 Testing Strategies in Community Health Centers
Baseline characteristics by cohort
| Measure |
RADx CHCs Testing Intervention Strategy
n=186171 Number of tests
Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs.
RADx CHCs testing intervention strategy: The study team will support partner CHCs to implement workflows with some combination of dedicated testing staff, off-site testing, outreach/communications to priority populations, and linkage with local contact tracing systems. Implementation support will take the form of practice facilitation, rapid cycle testing (by supporting CHCs to review their internal data to assess the impact of workflow changes), and expert consultation from the research team on testing technology and testing location design.
|
Usual Care Control
n=109911 Number of tests
Usual care control: CHCs implement testing strategies in accordance with their usual supports.
|
Total
n=296082 Number of tests
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=186171 Number of tests
|
38 years
n=109911 Number of tests
|
36 years
n=296082 Number of tests
|
|
Sex/Gender, Customized
Female
|
107486 Number of tests
n=186171 Number of tests
|
61507 Number of tests
n=109911 Number of tests
|
168993 Number of tests
n=296082 Number of tests
|
|
Sex/Gender, Customized
Male
|
78546 Number of tests
n=186171 Number of tests
|
48322 Number of tests
n=109911 Number of tests
|
126868 Number of tests
n=296082 Number of tests
|
|
Sex/Gender, Customized
Other
|
47 Number of tests
n=186171 Number of tests
|
40 Number of tests
n=109911 Number of tests
|
87 Number of tests
n=296082 Number of tests
|
|
Sex/Gender, Customized
Unknown
|
92 Number of tests
n=186171 Number of tests
|
42 Number of tests
n=109911 Number of tests
|
134 Number of tests
n=296082 Number of tests
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53751 Number of tests
n=186171 Number of tests
|
28834 Number of tests
n=109911 Number of tests
|
82585 Number of tests
n=296082 Number of tests
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107658 Number of tests
n=186171 Number of tests
|
66222 Number of tests
n=109911 Number of tests
|
173880 Number of tests
n=296082 Number of tests
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24762 Number of tests
n=186171 Number of tests
|
14855 Number of tests
n=109911 Number of tests
|
39617 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1094 Number of tests
n=186171 Number of tests
|
512 Number of tests
n=109911 Number of tests
|
1606 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
Asian
|
12662 Number of tests
n=186171 Number of tests
|
5754 Number of tests
n=109911 Number of tests
|
18416 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1923 Number of tests
n=186171 Number of tests
|
994 Number of tests
n=109911 Number of tests
|
2917 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
Black or African American
|
51987 Number of tests
n=186171 Number of tests
|
25108 Number of tests
n=109911 Number of tests
|
77095 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
White
|
69453 Number of tests
n=186171 Number of tests
|
46358 Number of tests
n=109911 Number of tests
|
115811 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
More than one race
|
229 Number of tests
n=186171 Number of tests
|
0 Number of tests
n=109911 Number of tests
|
229 Number of tests
n=296082 Number of tests
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
48823 Number of tests
n=186171 Number of tests
|
31185 Number of tests
n=109911 Number of tests
|
80008 Number of tests
n=296082 Number of tests
|
PRIMARY outcome
Timeframe: 85 weeks post-implementation compared to 35 weeks pre-implementationPopulation: No participants were enrolled in the study. The units analyzed represent the aggregate number of weekly COVID tests administered at the 6 community health centers.
Acceleration of covid testing volume during covid surges, estimated as the percent change in weekly covid testing volume trend for each 10% increase in covid cases. A slope value was estimated from a segmented regression model for the entire study period, which was then used to calculate a difference between the post- and pre-implementation periods.
Outcome measures
| Measure |
RADx CHCs Testing Intervention Strategy
n=186171 COVID tests
Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs for 85 weeks.
RADx CHCs testing intervention strategy: The study team will support partner CHCs to implement workflows with some combination of dedicated testing staff, off-site testing, outreach/communications to priority populations, and linkage with local contact tracing systems. Implementation support will take the form of practice facilitation, rapid cycle testing (by supporting CHCs to review their internal data to assess the impact of workflow changes), and expert consultation from the research team on testing technology and testing location design.
|
Usual Care Control
n=109911 COVID tests
Usual care control: CHCs implement testing strategies in accordance with their usual supports for 35 pre implementation weeks.
|
|---|---|---|
|
Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start
|
0.0965 Percent change
Interval 0.04 to 0.153
|
0.0128 Percent change
Interval -0.003 to 0.028
|
Adverse Events
RADx CHCs Testing Intervention Strategy
Usual Care Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place