Trial Outcomes & Findings for Project Resurgence Communication Trial (NCT NCT04418947)
NCT ID: NCT04418947
Last Updated: 2021-10-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11120 participants
Primary outcome timeframe
1 month
Results posted on
2021-10-28
Participant Flow
Participant milestones
| Measure |
No Intervention
No letter sent to the patient
|
MPM Control Letter
Communication type: Control letter vs. intervention letter
|
MPM Intervention Letter
Communication type: Control letter vs. intervention letter
|
Mailed Control Letter
Communication type: Control letter vs. intervention letter
|
Mailed Intervention Letter
Communication type: Control letter vs. intervention letter
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1108
|
1351
|
1351
|
3655
|
3655
|
|
Overall Study
COMPLETED
|
1108
|
1351
|
1351
|
3655
|
3655
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project Resurgence Communication Trial
Baseline characteristics by cohort
| Measure |
No Intervention
n=1108 Participants
No letter was sent to the patient.
|
MPM Control Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
MPM Intervention Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Control Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Intervention Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
Total
n=11120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
627 Participants
n=5 Participants
|
797 Participants
n=7 Participants
|
797 Participants
n=5 Participants
|
2032 Participants
n=4 Participants
|
2032 Participants
n=21 Participants
|
6285 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
481 Participants
n=5 Participants
|
554 Participants
n=7 Participants
|
554 Participants
n=5 Participants
|
1623 Participants
n=4 Participants
|
1623 Participants
n=21 Participants
|
4835 Participants
n=10 Participants
|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 17.0 • n=4 Participants
|
60.4 years
STANDARD_DEVIATION 17.1 • n=21 Participants
|
59.7 years
STANDARD_DEVIATION 16.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
609 Participants
n=5 Participants
|
757 Participants
n=7 Participants
|
756 Participants
n=5 Participants
|
1958 Participants
n=4 Participants
|
1994 Participants
n=21 Participants
|
6074 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
499 Participants
n=5 Participants
|
594 Participants
n=7 Participants
|
595 Participants
n=5 Participants
|
1697 Participants
n=4 Participants
|
1661 Participants
n=21 Participants
|
5046 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
320 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1039 Participants
n=5 Participants
|
1284 Participants
n=7 Participants
|
1298 Participants
n=5 Participants
|
3472 Participants
n=4 Participants
|
3443 Participants
n=21 Participants
|
10536 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
264 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
678 Participants
n=5 Participants
|
978 Participants
n=7 Participants
|
940 Participants
n=5 Participants
|
2145 Participants
n=4 Participants
|
2089 Participants
n=21 Participants
|
6830 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
291 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
1075 Participants
n=4 Participants
|
1087 Participants
n=21 Participants
|
2985 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
40 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
145 Participants
n=21 Participants
|
396 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
315 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
61 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
206 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
582 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
1108 participants
n=5 Participants
|
1351 participants
n=7 Participants
|
1351 participants
n=5 Participants
|
3655 participants
n=4 Participants
|
3655 participants
n=21 Participants
|
11120 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
No Intervention
n=1108 Participants
No letter was sent to the patient.
|
MPM Control Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
MPM Intervention Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Control Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Intervention Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
|---|---|---|---|---|---|
|
Percent of Participants With Visit or Procedure With Provider
|
45 Participants
|
64 Participants
|
63 Participants
|
176 Participants
|
200 Participants
|
SECONDARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
No Intervention
n=1108 Participants
No letter was sent to the patient.
|
MPM Control Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
MPM Intervention Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Control Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Intervention Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
|---|---|---|---|---|---|
|
Percent of Participants With Scheduled Visit or Procedure With Provider
|
130 Participants
|
181 Participants
|
197 Participants
|
490 Participants
|
571 Participants
|
SECONDARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
No Intervention
n=1108 Participants
No letter was sent to the patient.
|
MPM Control Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
MPM Intervention Letter
n=1351 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Control Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
Mailed Intervention Letter
n=3655 Participants
Communication type: Control letter vs. intervention letter
|
|---|---|---|---|---|---|
|
Percent of Participants With Completed Telemedicine Visit With Provider
|
4 Participants
|
19 Participants
|
17 Participants
|
44 Participants
|
52 Participants
|
Adverse Events
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MPM Control Letter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MPM Intervention Letter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed Control Letter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed Intervention Letter
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place