- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06078137
Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates
October 5, 2023 updated by: David Ring, University of Texas at Austin
Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates, Decision Support, and Patient Experience: A Hybrid Effectiveness-Implementation Study
in clinical practice has been curbed by issues related to the variability in use of these tools for decision-making, and universally poor completion rates over time.
Patients may not see the relevance of responding to questions about their health, and the results may not be reviewed by the clinician or presented and visualized with the patient.
The questions may seem impersonal (e.g.
too general and not directly assessing their individual goals, motivations, aspirations), irrelevant (e.g., asking about symptoms of depression when a person is seeking musculoskeletal specialty care) and insensitive (e.g., asking about sensitive subjects at the outset thereby disengaging the individual), and redundant or awkward (e.g., presenting questions that seem very similar or administered in strange orders).
Finally, PROMs may also confer some burden (e.g., long PROM questionnaires often used for research may be unnecessarily burdensome for patient care), and provide logistical challenges (e.g., difficulties in administering the tools at the right time points), adding to a poor patient experience.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigator sought to assess the impact of an enhanced and more personalized PROM strategy to overcome these barriers by providing i) a primer ahead of PROMs administration, ii) simple 3-part survey capturing capability, comfort, and calm, iii) a short distress and misconception survey, iv) goal setting question, v) summary sheet of PRO scores, and vi) a commitment intervention.
Patients will subsequently be requested to complete the CollaboRATE survey, JSPPE survey, and questions about their experience in relation to the new format of surveys (only if they were in the intervention group) before receiving a text message reminder around 6-weeks followed by a set of deprioritization questions and the 3-part capability, comfort, and calm survey.
Study Type
Interventional
Enrollment (Estimated)
200
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 Contact
- Name: Sina Ramtin
- Phone Number: 5124955067
- Email: sina.ramtin@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78701
- Recruiting
- University of Texas Health Austin
-
Contact:
- Sina Ramtin
- Phone Number: 512-495-5067
- Email: sina.ramtin@austin.utexas.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
All new patients English and Spanish speakers
Exclusion criteria:
Cognitive deficiency precluding PROM completion Language other than English or Spanish
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: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Patients randomized to intervention receive both usual Patient reported outcome measure (PROM) and new PROMs strategy (on the technology platform for English speakers and on REDCap/Qualtrix for Spanish Speakers) done after rooming.
|
Patients randomized to intervention receive both usual PROMs and new PROMs strategy
|
No Intervention: Control group
Patients go through the registration process which includes PROMs completion using Ipads.
Enrolled in the room at the end of the visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text
Time Frame: through study completion, an average of 6 weeks
|
We will assess the completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text.
|
through study completion, an average of 6 weeks
|
Completion of answered text
Time Frame: through study completion, an average of 6 weeks
|
We will assess the completion response rate.
|
through study completion, an average of 6 weeks
|
Completion of deprioritization options 1 or 2 at 6-week follow-up via text or email
Time Frame: through study completion, an average of 6 weeks
|
"1 = I got what I needed" "2 = I didn't receive anything useful" "3 = I'm still receiving care"
|
through study completion, an average of 6 weeks
|
Jefferson Scale of Patient's Perceptions of Physician Empathy
Time Frame: through study completion, an average of 6 weeks
|
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.
|
through study completion, an average of 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Ring, MD, Professor of orthopedic surgery at The university of Texas at Austin
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)
September 1, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
October 5, 2023
First Posted (Actual)
October 11, 2023
Study Record Updates
Last Update Posted (Actual)
October 11, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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