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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | ||
| MPM control letter | Active Comparator |
| |
| MPM intervention letter | Experimental |
| |
| Mailed control letter | Active Comparator |
| |
| Mailed intervention letter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication type | Other | Control letter vs. intervention letter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Visit or Procedure With Provider | 1 month |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34190999 | Derived | Cappola AR, Schriver ER, Mowery DL, Wollack C, Ives CT, Gonzales R, Cappella JN. Effect of Targeted Messaging on Return to In-Person Visits During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2115211. doi: 10.1001/jamanetworkopen.2021.15211. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention | No letter sent to the patient |
| FG001 | MPM Control Letter | Communication type: Control letter vs. intervention letter |
| FG002 | MPM Intervention Letter | Communication type: Control letter vs. intervention letter |
| FG003 | Mailed Control Letter | Communication type: Control letter vs. intervention letter |
| FG004 | Mailed Intervention Letter | Communication type: Control letter vs. intervention letter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention | No letter was sent to the patient. |
| BG001 | MPM Control Letter | Communication type: Control letter vs. intervention letter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Participants With Visit or Procedure With Provider | Posted | Count of Participants | Participants | 1 month |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Intervention | No letter was sent to the patient. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Cappola | University of Pennsylvania | 2155735359 | acappola@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2020 | Oct 25, 2021 | Prot_SAP_000.pdf |
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Randomized, double-blind, factorial design
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| BG002 | MPM Intervention Letter | Communication type: Control letter vs. intervention letter |
| BG003 | Mailed Control Letter | Communication type: Control letter vs. intervention letter |
| BG004 | Mailed Intervention Letter | Communication type: Control letter vs. intervention letter |
| BG005 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mailed Control Letter |
Communication type: Control letter vs. intervention letter |
| OG004 | Mailed Intervention Letter | Communication type: Control letter vs. intervention letter |
|
|
| Secondary | Percent of Participants With Scheduled Visit or Procedure With Provider | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Percent of Participants With Completed Telemedicine Visit With Provider | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 1,108 |
| 0 |
| 1,108 |
| 0 |
| 1,108 |
| EG001 | MPM Control Letter | Communication type: Control letter vs. intervention letter | 0 | 1,351 | 0 | 1,351 | 0 | 1,351 |
| EG002 | MPM Intervention Letter | Communication type: Control letter vs. intervention letter | 0 | 1,351 | 0 | 1,351 | 0 | 1,351 |
| EG003 | Mailed Control Letter | Communication type: Control letter vs. intervention letter | 0 | 3,655 | 0 | 3,655 | 0 | 3,655 |
| EG004 | Mailed Intervention Letter | Communication type: Control letter vs. intervention letter | 0 | 3,655 | 0 | 3,655 | 0 | 3,655 |
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