Communication ResearchNCT04418947
Project Resurgence Communication Trial
A study testing Communication type in people with Communication Research, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Communication Research
- What is being tested?
- Communication type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Death
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
- Conditions
- Communication Research
- Being tested
- Communication type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication typeOther
Control letter vs. intervention letter
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| MPM control letter | Active comparator | Not described Receives: Other: Communication type |
| MPM intervention letter | Experimental | Not described Receives: Other: Communication type |
| Mailed control letter | Active comparator | Not described Receives: Other: Communication type |
| Mailed intervention letter | Experimental | Not described Receives: Other: Communication type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Visit or Procedure With Provider
Measured: 1 month
Secondary outcomes (2)
Percent of Participants With Scheduled Visit or Procedure With Provider
Measured: 1 month
Percent of Participants With Completed Telemedicine Visit With Provider
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Jun 2020
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Communication ResearchStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, double-blind, factorial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Cappola, MD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418947
- Sponsor's protocol ID
- 843220
- Status last verified
- Oct 2021
- First submitted
- 29 May 2020
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04418947
- Acronym / sponsor ID
- 843220
- Conditions
- Communication Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,120 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 28 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, double-blind, factorial design
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| MPM control letter | Active comparator | Other: Communication type |
| MPM intervention letter | Experimental | Other: Communication type |
| Mailed control letter | Active comparator | Other: Communication type |
| Mailed intervention letter | Experimental | Other: Communication type |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication typeControl letter vs. intervention letter | Other | MPM control letter, MPM intervention letter, Mailed control letter, Mailed intervention letter |
Primary outcome
Percent of Participants With Visit or Procedure With Provider
Time frame: 1 month
2 secondary outcomes
Percent of Participants With Scheduled Visit or Procedure With Provider
Time frame: 1 month
Percent of Participants With Completed Telemedicine Visit With Provider
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34190999Cappola 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication type in people with Communication Research, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Visit or Procedure With Provider (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.