Covid19
Conditions
Keywords
implementation science, community health center
Brief summary
This project is part of a competitive revision to accelerate COVID-19 testing in underserved populations. The overall aim is to implement strategies to expand COVID testing in hotspot communities in MA, through 6 community health center (CHC)-community partnerships. A base strategy will be implemented at all sites. A tailored strategy unique to local populations will be added and tested in a stepped wedge design.
Interventions
OTHERRADx 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.
OTHERUsual care control
CHCs implement testing strategies in accordance with their usual supports.
Sponsors
Dana-Farber Cancer Institute
Harvard School of Public Health (HSPH)
Massachusetts League of Community Health Centers
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Participants are patients at the intervention or control CHCs or members of the local community. The participating sites constitute one group; a set of matched control CHCs that will conduct testing as usual constitute the second group.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start | 85 weeks post-implementation compared to 35 weeks pre-implementation | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 186,171 |
| Usual Care Control Usual care control: CHCs implement testing strategies in accordance with their usual supports. | 0 |
| Usual Care Control Usual care control: CHCs implement testing strategies in accordance with their usual supports. | 109,911 |
| Total | 296,082 |
Baseline characteristics
| Characteristic | RADx CHCs Testing Intervention Strategy | Usual Care Control | Total |
|---|---|---|---|
| Age, Continuous | 34 years | 38 years | 36 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53751 Number of tests | 28834 Number of tests | 82585 Number of tests |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107658 Number of tests | 66222 Number of tests | 173880 Number of tests |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24762 Number of tests | 14855 Number of tests | 39617 Number of tests |
| Race (NIH/OMB) American Indian or Alaska Native | 1094 Number of tests | 512 Number of tests | 1606 Number of tests |
| Race (NIH/OMB) Asian | 12662 Number of tests | 5754 Number of tests | 18416 Number of tests |
| Race (NIH/OMB) Black or African American | 51987 Number of tests | 25108 Number of tests | 77095 Number of tests |
| Race (NIH/OMB) More than one race | 229 Number of tests | 0 Number of tests | 229 Number of tests |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1923 Number of tests | 994 Number of tests | 2917 Number of tests |
| Race (NIH/OMB) Unknown or Not Reported | 48823 Number of tests | 31185 Number of tests | 80008 Number of tests |
| Race (NIH/OMB) White | 69453 Number of tests | 46358 Number of tests | 115811 Number of tests |
| Sex/Gender, Customized Female | 107486 Number of tests | 61507 Number of tests | 168993 Number of tests |
| Sex/Gender, Customized Male | 78546 Number of tests | 48322 Number of tests | 126868 Number of tests |
| Sex/Gender, Customized Other | 47 Number of tests | 40 Number of tests | 87 Number of tests |
| Sex/Gender, Customized Unknown | 92 Number of tests | 42 Number of tests | 134 Number of tests |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start
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.
Time frame: 85 weeks post-implementation compared to 35 weeks pre-implementation
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RADx CHCs Testing Intervention Strategy | Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start | 0.0965 Percent change |
| Usual Care Control | Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start | 0.0128 Percent change |