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Project Resurgence Communication Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418947
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Cappola, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Communication Research Other: Communication type Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Randomized, double-blind, factorial design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of the Effectiveness of Communication Strategies on the Return to In-Person Visits to a Medical Center After the Emergence of COVID-19: A Randomized Trial
Actual Study Start Date : June 15, 2020
Actual Primary Completion Date : July 17, 2020
Actual Study Completion Date : July 17, 2020

Arm Intervention/treatment
No Intervention: No intervention
Active Comparator: MPM control letter Other: Communication type
Control letter vs. intervention letter

Experimental: MPM intervention letter Other: Communication type
Control letter vs. intervention letter

Active Comparator: Mailed control letter Other: Communication type
Control letter vs. intervention letter

Experimental: Mailed intervention letter Other: Communication type
Control letter vs. intervention letter




Primary Outcome Measures :
  1. Percent with visit or procedure with provider [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Percent with scheduled visit or procedure with provider [ Time Frame: 1 month ]
  2. Percent with completed telemedicine visit with provider [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418947


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Anne Cappola, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04418947    
Other Study ID Numbers: 843220
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No