search
Back to results

Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates

Primary Purpose

PROM

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual PROMs and new PROMs strategy
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PROM

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All new patients English and Spanish speakers Exclusion criteria: Cognitive deficiency precluding PROM completion Language other than English or Spanish

Sites / Locations

  • University of Texas Health AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control group

Arm Description

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 go through the registration process which includes PROMs completion using Ipads. Enrolled in the room at the end of the visit.

Outcomes

Primary Outcome Measures

Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text
We will assess the completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text.
Completion of answered text
We will assess the completion response rate.
Completion of deprioritization options 1 or 2 at 6-week follow-up via text or email
"1 = I got what I needed" "2 = I didn't receive anything useful" "3 = I'm still receiving care"
Jefferson Scale of Patient's Perceptions of Physician Empathy
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2023
Last Updated
October 5, 2023
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT06078137
Brief Title
Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates
Official Title
Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates, Decision Support, and Patient Experience: A Hybrid Effectiveness-Implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PROM

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients go through the registration process which includes PROMs completion using Ipads. Enrolled in the room at the end of the visit.
Intervention Type
Other
Intervention Name(s)
Usual PROMs and new PROMs strategy
Intervention Description
Patients randomized to intervention receive both usual PROMs and new PROMs strategy
Primary Outcome Measure Information:
Title
Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text
Description
We will assess the 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
Title
Completion of answered text
Description
We will assess the completion response rate.
Time Frame
through study completion, an average of 6 weeks
Title
Completion of deprioritization options 1 or 2 at 6-week follow-up via text or email
Description
"1 = I got what I needed" "2 = I didn't receive anything useful" "3 = I'm still receiving care"
Time Frame
through study completion, an average of 6 weeks
Title
Jefferson Scale of Patient's Perceptions of Physician Empathy
Description
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.
Time Frame
through study completion, an average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All new patients English and Spanish speakers Exclusion criteria: Cognitive deficiency precluding PROM completion Language other than English or Spanish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Ramtin
Phone
5124955067
Email
sina.ramtin@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD
Organizational Affiliation
Professor of orthopedic surgery at The university of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sina Ramtin
Phone
512-495-5067
Email
sina.ramtin@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates

We'll reach out to this number within 24 hrs