Orthopedic DisorderNCT04983641
Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit
A study testing Pre-Visit Messages in people with Orthopedic Disorder, run by Henry Ford Health System at 1 site in United States.
Trial summary
Patient-Reported Outcomes Measurement Information System (PROMIS) forms will be administered remotely to consecutive Orthopaedic patients presenting for new physician clinic visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Pre-Visit Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Orthopedic Disorder
- Being tested
- Pre-Visit Messages
- Keywords
- PROMIS, Patient Reported Outcomes Measurement Information System
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Visit MessagesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pre-Visit Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 week
Secondary outcomes (2)
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.
Measured: 1 week
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Aug 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Makhni, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983641
- Sponsor's protocol ID
- 13895
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not sharing individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit: A Prospective, Randomized, Control Trial
- ClinicalTrials.gov ID
- NCT04983641
- Acronym / sponsor ID
- 13895
- Conditions
- Orthopedic Disorder
- Keywords
- PROMIS, Patient Reported Outcomes Measurement Information System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Pre-Visit Messageso 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. |
| Digital Patient Portal "MyChart" Arm | Experimental | Other: Pre-Visit Messageso 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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")
Key exclusion criteria (6 listed)
- 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")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Visit MessagesPatients 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 | Other | Digital Patient Portal "MyChart" Arm, E-mail Arm |
Primary outcome
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.
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.
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.
2 secondary outcomes
Time to pre-visit PROMIS form completion
Time frame: 1 week
PROMIS form completion rates according to patient demographics
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No. We are not sharing individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Visit Messages in people with Orthopedic Disorder, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.