PROMIS and Patient Satisfaction

NCT ID: NCT04654910

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2021-12-01

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.

Detailed Description

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Conditions

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Ankle Pathology Foot Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

enrolled subjects that do NOT receive explanation of PROMIS measures during visit.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Subjects will complete the PROMIS assessment but will not receive an explanation of the tool.

Intervention

enrolled subjects that DO receive explanation of PROMIS measures during visit.

Group Type ACTIVE_COMPARATOR

PROMIS Score Explanation

Intervention Type BEHAVIORAL

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.

Interventions

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PROMIS Score Explanation

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.

Intervention Type BEHAVIORAL

Placebo

Subjects will complete the PROMIS assessment but will not receive an explanation of the tool.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Orthopaedic Foot and Ankle Society

UNKNOWN

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Judy Baumhauer, MD

Professor and Associate Chair Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00005316

Identifier Type: -

Identifier Source: org_study_id

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