- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983641
Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit
July 20, 2021 updated by: Eric Makhni, Henry Ford Health System
Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit: A Prospective, Randomized, Control Trial
Patient-Reported Outcomes Measurement Information System (PROMIS) forms will be administered remotely to consecutive Orthopaedic patients presenting for new physician clinic visits.
These patients will be sent either reminder e-mails, reminder digital patient portal ("MyChart") messages, or no reminder messages at all concerning PROMIS form completion at timepoints prior to their respective clinic visits and PROMIS form completion rates will consequently be assessed.
The primary objective of this study is to develop an understanding of whether pre-visit reminder messages influence PROMIS form completion in Orthopaedic patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
291
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years old
- English speaking
- No previous PROM form completion at the healthcare system
- Seeing a respective orthopedic provider for the first time
- Active registration with the electronic medical record (EMR; Epic, Verona, WI) patient portal ("MyChart")
- Valid e-mail address.
Exclusion Criteria:
- Under 18 years old
- Non-English speaking
- Previous PROM form completion at the healthcare system
- Seeing a respective orthopedic provider for follow-up
- No active registration with the electronic medical record (EMR; Epic, Verona, WI) patient portal ("MyChart")
- No valid e-mail address.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control - No Pre-Visit Message
o Patients were assigned PROMIS forms in the domains of Depression (PROMIS-D) and Pain Interference (PROMIS-PI) in addition to Upper Extremity Function (PROMIS-UE) and/or Physical Function (PROMIS-PF).
These forms were available for remote completion in each respective patient's MyChart portal at 1 week prior to their clinic appointment.
Patients in this arm were not sent any reminder e-mails or MyChart messages concerning PROMIS form completion at any timepoint prior to their scheduled clinic visit.
|
|
|
Experimental: E-mail Arm
o Patients were assigned PROMIS forms in the domains of Depression (PROMIS-D) and Pain Interference (PROMIS-PI) in addition to Upper Extremity Function (PROMIS-UE) and/or Physical Function (PROMIS-PF).
These forms were available for remote completion in each respective patient's MyChart portal at 1 week prior to their clinic appointment.
Patients in this arm were sent an initial reminder e-mail message at 1 week prior to their scheduled clinic visit regarding PROMIS form completion.
If patient's did not fill out PROMIS forms by 3 days prior to their visit, they were sent a second reminder e-mail message.
|
Patients in both experimental arms (E-mail and Digital Patient Portal "MyChart") were sent pre-visit messages regarding PROMIS form completion via each respective modality at 1 week and also 3 days prior to their respective Orthopaedic clinic visits
|
|
Experimental: Digital Patient Portal "MyChart" Arm
o Patients were assigned PROMIS forms in the domains of Depression (PROMIS-D) and Pain Interference (PROMIS-PI) in addition to Upper Extremity Function (PROMIS-UE) and/or Physical Function (PROMIS-PF).
These forms were available for remote completion in each respective patient's MyChart portal at 1 week prior to their clinic appointment.
Patient's in this arm were sent an initial reminder MyChart message at 1 week prior to their scheduled clinic visit regarding PROMIS form completion.
If patients did not fill out PROMIS forms by 3 days prior to their visit, they were sent a second reminder MyChart message.
|
Patients in both experimental arms (E-mail and Digital Patient Portal "MyChart") were sent pre-visit messages regarding PROMIS form completion via each respective modality at 1 week and also 3 days prior to their respective Orthopaedic clinic visits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-visit PROMIS completion rates in orthopaedic patients receiving reminder e-mails, digital patient portal ("MyChart") message reminders, or no messages prior to scheduled clinic visit
Time Frame: 1 week
|
Investigators will assess whether reminder messages prior to clinic visit have an impact on both remote pre-visit and overall PROMIS form completion rates in orthopaedic patients.
Patients completing a single assigned PROMIS form will be regarded as having PROMIS completion.
|
1 week
|
|
At-visit PROMIS completion rates in orthopaedic patients receiving reminder e-mails, digital patient portal ("MyChart") message reminders, or no messages prior to scheduled clinic visit
Time Frame: 1 week
|
Investigators will assess whether reminder messages prior to clinic visit have an impact on both remote pre-visit and overall PROMIS form completion rates in orthopaedic patients.
Patients completing a single assigned PROMIS form will be regarded as having PROMIS completion.
|
1 week
|
|
Overall (Pre-visit and at-visit) PROMIS completion rates in orthopaedic patients receiving reminder e-mails, digital patient portal ("MyChart") message reminders, or no messages prior to scheduled clinic visit
Time Frame: 1 week
|
Investigators will assess whether reminder messages prior to clinic visit have an impact on both remote pre-visit and overall PROMIS form completion rates in orthopaedic patients.
Patients completing a single assigned PROMIS form will be regarded as having PROMIS completion.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to pre-visit PROMIS form completion
Time Frame: 1 week
|
This is achieved by assessing the timepoint (in days) at which patients completed assigned PROMIS forms prior to their respective clinic visit in each of the designated study arms.
|
1 week
|
|
PROMIS form completion rates according to patient demographics
Time Frame: 1 week
|
This is achieved by assessing how PROMIS form completion for the enrolled study cohort as a whole (irrespective of arm assignment) varies according to patient race, age, gender, and sub-specialty of visit
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
December 7, 2020
Study Completion (Actual)
December 7, 2020
Study Registration Dates
First Submitted
July 3, 2021
First Submitted That Met QC Criteria
July 20, 2021
First Posted (Actual)
July 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 30, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13895
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We are not sharing individual participant data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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