NCT04983641

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 3, 2021

Last Update Submit

July 20, 2021

Conditions

Keywords

PROMISPatient Reported Outcomes Measurement Information System

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    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 Outcomes (2)

  • Time to pre-visit PROMIS form completion

    1 week

  • PROMIS form completion rates according to patient demographics

    1 week

Study Arms (3)

Control - No Pre-Visit Message

NO INTERVENTION

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.

E-mail Arm

EXPERIMENTAL

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.

Other: Pre-Visit Messages

Digital Patient Portal "MyChart" Arm

EXPERIMENTAL

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.

Other: Pre-Visit Messages

Interventions

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

Digital Patient Portal "MyChart" ArmE-mail Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Center for Patient Reported Outcome Measures; Director of Quality and Informatics, Orthopedic Service Line

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 30, 2021

Study Start

August 1, 2020

Primary Completion

December 7, 2020

Study Completion

December 7, 2020

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

We are not sharing individual participant data.

Locations