What side effects are associated with this type of intervention?

Common challenges associated with the implementation of Patient-Reported Outcome Measures (PROMs) include patient disengagement due to impersonal or irrelevant questions, logistical difficulties in administering the tools at appropriate times, and the burden of lengthy questionnaires. These issues can lead to poor completion rates and variability in the use of PROMs for decision-making. While these are not traditional 'side effects,' they represent significant barriers to the effective use of PROMs in clinical practice.

What other types of research exist?

Promising alternatives to Enhanced PROMs System for 2024 include: 1) Digital health platforms with AI-driven personalization to tailor questions based on patient history and real-time data. 2) Mobile health apps that integrate seamlessly with electronic health records (EHRs) for streamlined data collection and analysis. 3) Wearable devices that continuously monitor patient health metrics and automatically update PROMs. 4) Telehealth solutions that incorporate real-time patient feedback during virtual consultations. These innovations aim to enhance patient engagement, improve data relevance, and reduce the burden of data collection.

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Enhanced PROM Strategy for Patient-Reported Outcomes

Q: What prior FDA approvals exist?

There are no specific FDA approvals for treatments solely focused on Patient-Reported Outcome Measures (PROMs). However, various digital health tools and platforms have been developed to enhance the collection and utilization of PROMs in clinical practice. These tools aim to improve the relevance, personalization, and logistical efficiency of PROMs, aligning with the goals of the Enhanced PROMs System. Such platforms often integrate with electronic health records (EHRs) to streamline data collection and provide real-time feedback to both patients and clinicians, thereby enhancing patient engagement and clinical decision-making.

N/A

Recruiting

Led By David Ring, MD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Language other than English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new way of making health surveys more relevant and easier for patients. It aims to improve patient experience by simplifying questions, addressing concerns, and clearly summarizing results.

Who is the study for?

This trial is for new patients who can communicate in English or Spanish. It's not suitable for individuals with cognitive issues that prevent them from completing patient-reported outcome measures (PROMs).

What is being tested?

The study compares the usual way of collecting PROMs with an enhanced strategy to see if it improves how often patients complete these health questionnaires.

What are the potential side effects?

There are no direct side effects associated with this trial as it involves answering questions about personal health experiences rather than testing a medical treatment.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I speak a language other than English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text

Completion of answered text

Completion of deprioritization options 1 or 2 at 6-week follow-up via text or email

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control groupActive Control1 Intervention

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for improving Patient-Reported Outcome Measures (PROMs) focus on enhancing the relevance, personalization, and logistical efficiency of the data collection process. Mechanisms of action include tailoring questionnaires to address specific patient concerns, ensuring that the questions are directly relevant to the patient's condition and treatment goals, and streamlining the administration process to reduce burden and improve completion rates. These improvements matter because they lead to more accurate and meaningful data, which can better inform clinical decisions and ultimately enhance patient care and outcomes.

Patient-Reported Outcomes Measurement Information System physical function instruments compare favorably to legacy patient-reported outcome measures in spine patients: a systematic review of the literature.COHESION: core outcomes in neonatal encephalopathy (protocol).What Is the Impact of the COVID-19 Pandemic on Quality of Life and Other Patient-reported Outcomes? An Analysis of the Hand-Wrist Study Cohort.