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Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit

Primary Purpose

Orthopedic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-Visit Messages
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Orthopedic Disorder focused on measuring PROMIS, Patient Reported Outcomes Measurement Information System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control - No Pre-Visit Message

E-mail Arm

Digital Patient Portal "MyChart" Arm

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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
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.
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
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.

Secondary Outcome Measures

Time to pre-visit PROMIS form completion
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.
PROMIS form completion rates according to patient demographics
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

Full Information

First Posted
July 3, 2021
Last Updated
July 20, 2021
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04983641
Brief Title
Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit
Official Title
Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit: A Prospective, Randomized, Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
Keywords
PROMIS, Patient Reported Outcomes Measurement Information System

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - No Pre-Visit Message
Arm Type
No Intervention
Arm Description
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.
Arm Title
E-mail Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Digital Patient Portal "MyChart" Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pre-Visit Messages
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 week
Title
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
Description
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.
Time Frame
1 week
Title
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
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Time to pre-visit PROMIS form completion
Description
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.
Time Frame
1 week
Title
PROMIS form completion rates according to patient demographics
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not sharing individual participant data.

Learn more about this trial

Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit

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