PROMIS and Patient Satisfaction

Study Overview
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Brief Summary
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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.

Official Title
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Does Patient-Reported Outcome Measure Use in Clinic Visits Improve Patient Satisfaction and Experience? A Randomized, Controlled Trial

Conditions
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Ankle Pathology, Foot Pathology

Intervention / Treatment
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* Behavioral: PROMIS Score Explanation
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Patients over the age of 18 New patient at the foot and ankle clinic Exclusion Patients under the age of 18 Patients presenting for a Follow up visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>enrolled subjects that do NOT receive explanation of PROMIS measures during visit. | Behavioral: Placebo<br>* Subjects will complete the PROMIS assessment but will not receive an explanation of the tool.<br>|
| Active Comparator: Intervention<br>enrolled subjects that DO receive explanation of PROMIS measures during visit. | Behavioral: PROMIS Score Explanation<br>* The surgeon completing the clinical visit with the participant will explain what the PROMIS tool is, the purpose of the tool and what the participant's scores mean using a script.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pain interference domain measured by PROMIS | 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. | baseline, before intervention | 
| mean Patient Activation Measure (PAM) | 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. | baseline, after intervention | 
| percent of participant who respond favorably on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS) | 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. | baseline, after intervention | 
| mean depression | 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. | baseline, before intervention | 
| mean physical function | 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. | baseline, before intervention |