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

PROM Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078137
• Other study ID #: STUDY00001696
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: University of Texas at Austin
• Contact: Sina Ramtin
• Phone: 5124955067
• Email: sina.ramtin[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

All new patients English and Spanish speakers

Exclusion criteria:

Cognitive deficiency precluding PROM completion Language other than English or Spanish

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PROM

Intervention

Other:
• Usual PROMs and new PROMs strategy
Patients randomized to intervention receive both usual PROMs and new PROMs strategy

Locations

Country	Name	City	State
United States	University of Texas Health Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 6 weeks
Primary	Completion of answered text	We will assess the completion response rate.	through study completion, an average of 6 weeks
Primary	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"	through study completion, an average of 6 weeks
Primary	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.	through study completion, an average of 6 weeks