Communication Research
Conditions
Brief summary
Randomized, double-blind, of standard of care vs additional communication and factorial design of intervention letter vs. control letter and EHR vs mail delivery mechanism in patients who canceled visits and did not reschedule over a 90 day period starting March 9, 2020.
Interventions
OTHERCommunication type
Control letter vs. intervention letter
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, factorial design
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with a cancellation or failure to show for a procedure or visit from March 9, 2020 through June 7, 2020 (90 days) and who have not rescheduled as of the date of randomization
Exclusion criteria
* Death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Participants With Visit or Procedure With Provider | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Percent of Participants With Scheduled Visit or Procedure With Provider | 1 month |
| Percent of Participants With Completed Telemedicine Visit With Provider | 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Intervention No letter was sent to the patient. | 1,108 |
| MPM Control Letter Communication type: Control letter vs. intervention letter | 1,351 |
| MPM Intervention Letter Communication type: Control letter vs. intervention letter | 1,351 |
| Mailed Control Letter Communication type: Control letter vs. intervention letter | 3,655 |
| Mailed Intervention Letter Communication type: Control letter vs. intervention letter | 3,655 |
| Total | 11,120 |
Baseline characteristics
| Characteristic | No Intervention | MPM Control Letter | MPM Intervention Letter | Mailed Control Letter | Mailed Intervention Letter | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 481 Participants | 554 Participants | 554 Participants | 1623 Participants | 1623 Participants | 4835 Participants |
| Age, Categorical Between 18 and 65 years | 627 Participants | 797 Participants | 797 Participants | 2032 Participants | 2032 Participants | 6285 Participants |
| Age, Continuous | 60.0 years STANDARD_DEVIATION 6.9 | 58.4 years STANDARD_DEVIATION 16 | 58.4 years STANDARD_DEVIATION 16.2 | 59.9 years STANDARD_DEVIATION 17 | 60.4 years STANDARD_DEVIATION 17.1 | 59.7 years STANDARD_DEVIATION 16.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 42 Participants | 28 Participants | 104 Participants | 118 Participants | 320 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1039 Participants | 1284 Participants | 1298 Participants | 3472 Participants | 3443 Participants | 10536 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants | 25 Participants | 25 Participants | 79 Participants | 94 Participants | 264 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 40 Participants | 46 Participants | 54 Participants | 111 Participants | 145 Participants | 396 Participants |
| Race/Ethnicity, Customized Black | 291 Participants | 259 Participants | 273 Participants | 1075 Participants | 1087 Participants | 2985 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants | 1 Participants | 1 Participants | 5 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 37 Participants | 32 Participants | 33 Participants | 113 Participants | 100 Participants | 315 Participants |
| Race/Ethnicity, Customized Unknown | 61 Participants | 35 Participants | 50 Participants | 206 Participants | 230 Participants | 582 Participants |
| Race/Ethnicity, Customized White | 678 Participants | 978 Participants | 940 Participants | 2145 Participants | 2089 Participants | 6830 Participants |
| Region of Enrollment United States | 1108 participants | 1351 participants | 1351 participants | 3655 participants | 3655 participants | 11120 participants |
| Sex: Female, Male Female | 609 Participants | 757 Participants | 756 Participants | 1958 Participants | 1994 Participants | 6074 Participants |
| Sex: Female, Male Male | 499 Participants | 594 Participants | 595 Participants | 1697 Participants | 1661 Participants | 5046 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,108 | 0 / 1,351 | 0 / 1,351 | 0 / 3,655 | 0 / 3,655 |
| other Total, other adverse events | 0 / 1,108 | 0 / 1,351 | 0 / 1,351 | 0 / 3,655 | 0 / 3,655 |
| serious Total, serious adverse events | 0 / 1,108 | 0 / 1,351 | 0 / 1,351 | 0 / 3,655 | 0 / 3,655 |
Outcome results
Primary
Percent of Participants With Visit or Procedure With Provider
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Intervention | Percent of Participants With Visit or Procedure With Provider | 45 Participants |
| MPM Control Letter | Percent of Participants With Visit or Procedure With Provider | 64 Participants |
| MPM Intervention Letter | Percent of Participants With Visit or Procedure With Provider | 63 Participants |
| Mailed Control Letter | Percent of Participants With Visit or Procedure With Provider | 176 Participants |
| Mailed Intervention Letter | Percent of Participants With Visit or Procedure With Provider | 200 Participants |
Secondary
Percent of Participants With Completed Telemedicine Visit With Provider
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Intervention | Percent of Participants With Completed Telemedicine Visit With Provider | 4 Participants |
| MPM Control Letter | Percent of Participants With Completed Telemedicine Visit With Provider | 19 Participants |
| MPM Intervention Letter | Percent of Participants With Completed Telemedicine Visit With Provider | 17 Participants |
| Mailed Control Letter | Percent of Participants With Completed Telemedicine Visit With Provider | 44 Participants |
| Mailed Intervention Letter | Percent of Participants With Completed Telemedicine Visit With Provider | 52 Participants |
Secondary
Percent of Participants With Scheduled Visit or Procedure With Provider
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Intervention | Percent of Participants With Scheduled Visit or Procedure With Provider | 130 Participants |
| MPM Control Letter | Percent of Participants With Scheduled Visit or Procedure With Provider | 181 Participants |
| MPM Intervention Letter | Percent of Participants With Scheduled Visit or Procedure With Provider | 197 Participants |
| Mailed Control Letter | Percent of Participants With Scheduled Visit or Procedure With Provider | 490 Participants |
| Mailed Intervention Letter | Percent of Participants With Scheduled Visit or Procedure With Provider | 571 Participants |