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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Pre-Visit Messages
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.
Other: Pre-Visit Messages
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry Ford Health System

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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