PROMIS and Patient Satisfaction

Not Applicable

Completed

• Conditions: Ankle Pathology; Foot Pathology
• Interventions: Behavioral: Placebo; Behavioral: PROMIS Score Explanation

• Registration Number: NCT04654910
• Lead Sponsor: University of Rochester

Brief Summary

The primary aim for this study is to determine if patient satisfaction and experience is improved with the active discussion/inclusion of PROMIS scores during new foot and ankle clinic patient visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2021-02-24
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Placebo	enrolled subjects that do NOT receive explanation of PROMIS measures during visit.
Intervention	PROMIS Score Explanation	enrolled subjects that DO receive explanation of PROMIS measures during visit.

Primary Outcome Measures

Name	Time	Method
mean physical function	baseline, before intervention	PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher physical function effect.
mean Patient Activation Measure (PAM)	baseline, after intervention	Our primary outcome measure is the Patient Activation Measure (PAM). The PAM is a 13-item scale with a 5-point Likert response scale for all questions. Raw scores are scaled to a range of 0-100 with 100 being the highest activation in self- management.
mean depression	baseline, before intervention	PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher depression effect.
percent of participant who respond favorably on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS)	baseline, after intervention	We will assess scores on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS) survey. This is a standardized tool to measure patients' perception of care provided by physicians in an office setting. Specifically, for our analysis will we focus specifically on the individual question to assess communication. We will compare the percentage of participants in the intervention versus control group who respond favorably to this question using a chi-square test of association.
mean pain interference domain measured by PROMIS	baseline, before intervention	PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher pain interference effect.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States