NCT04418947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 28, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

May 29, 2020

Results QC Date

October 25, 2021

Last Update Submit

October 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent of Participants With Visit or Procedure With Provider

    1 month

Secondary Outcomes (2)

  • Percent of Participants With Scheduled Visit or Procedure With Provider

    1 month

  • Percent of Participants With Completed Telemedicine Visit With Provider

    1 month

Study Arms (5)

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

Interventions

Control letter vs. intervention letter

MPM control letterMPM intervention letterMailed control letterMailed intervention letter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr. Anne Cappola
Organization
University of Pennsylvania

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Randomized, double-blind, factorial design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 5, 2020

Study Start

June 15, 2020

Primary Completion

July 17, 2020

Study Completion

July 17, 2020

Last Updated

October 28, 2021

Results First Posted

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations