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CompletedNCT04418947Updated Oct 28, 2021Results posted

Project Resurgence Communication Trial

An interventional study of Communication type in Communication Research, sponsored by University of Pennsylvania. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
11,120
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Communication Research
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Death
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
11,120 participants (actual)

Study arms

  • No intervention
    No intervention
  • Active comparator
    MPM control letter

    Other: Communication type

  • Experimental
    MPM intervention letter

    Other: Communication type

  • Active comparator
    Mailed control letter

    Other: Communication type

  • Experimental
    Mailed intervention letter

    Other: Communication type

Interventions

  • OtherCommunication type

    Control letter vs. intervention letter

06

What researchers measure

Primary outcomes

  1. Percent of Participants With Visit or Procedure With Provider

    Time frame: 1 month

Secondary outcomes

  1. Percent of Participants With Scheduled Visit or Procedure With Provider

    Time frame: 1 month

  2. Percent of Participants With Completed Telemedicine Visit With Provider

    Time frame: 1 month

07

Results

Posted Oct 28, 2021

Participant flow

Participant flow — Overall Study
MilestoneNo InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention Letter
Started11081351135136553655
Completed11081351135136553655
Not completed00000

Outcome measures

PrimaryPercent of Participants With Visit or Procedure With Provider
Time frame:
1 month
Reported as:
Count of participants · Participants
Percent of Participants With Visit or Procedure With Provider
ParticipantsNo InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention Letter
Percent of Participants With Visit or Procedure With Provider456463176200
SecondaryPercent of Participants With Scheduled Visit or Procedure With Provider
Time frame:
1 month
Reported as:
Count of participants · Participants
Percent of Participants With Scheduled Visit or Procedure With Provider
ParticipantsNo InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention Letter
Percent of Participants With Scheduled Visit or Procedure With Provider130181197490571
SecondaryPercent of Participants With Completed Telemedicine Visit With Provider
Time frame:
1 month
Reported as:
Count of participants · Participants
Percent of Participants With Completed Telemedicine Visit With Provider
ParticipantsNo InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention Letter
Percent of Participants With Completed Telemedicine Visit With Provider419174452

Adverse events

Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
No Intervention0/1,108 (0%)0/1,108 (0%)0/1,108 (0%)
MPM Control Letter0/1,351 (0%)0/1,351 (0%)0/1,351 (0%)
MPM Intervention Letter0/1,351 (0%)0/1,351 (0%)0/1,351 (0%)
Mailed Control Letter0/3,655 (0%)0/3,655 (0%)0/3,655 (0%)
Mailed Intervention Letter0/3,655 (0%)0/3,655 (0%)0/3,655 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)No InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention LetterTotal
<=18 years000000
Between 18 and 65 years627797797203220326285
>=65 years481554554162316234835
Age, Continuous
Age, Continuous(years)No InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention LetterTotal
Mean60.0 ± 6.958.4 ± 16.058.4 ± 16.259.9 ± 17.060.4 ± 17.159.7 ± 16.8
Sex: Female, Male
Sex: Female, Male(Participants)No InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention LetterTotal
Female609757756195819946074
Male499594595169716615046
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)No InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention LetterTotal
Hispanic or Latino284228104118320
Not Hispanic or Latino1039128412983472344310536
Unknown or Not Reported4125257994264
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)No InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention LetterTotal
White678978940214520896830
Black291259273107510872985
Asian/Pacific Islander404654111145396
Native American1115412
Other373233113100315
Unknown613550206230582
Region of Enrollment
Region of Enrollment(participants)No InterventionMPM Control LetterMPM Intervention LetterMailed Control LetterMailed Intervention LetterTotal
United States1108135113513655365511120
08

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Publications

  • 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. PubMed 34190999 ↗

Study documents

  • Protocol and statistical analysis plan · May 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04418947
Lead sponsor
University of Pennsylvania
Responsible party
Anne Cappola, MD (Professor, University of Pennsylvania) — Principal investigator
First posted
Jun 5, 2020
Start date
Jun 15, 2020
Primary completion
Jul 17, 2020
Completion
Jul 17, 2020
Results posted
Oct 28, 2021
Last update
Oct 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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