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PROMIS and Patient Satisfaction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654910
Enrollment
275
Registered
2020-12-04
Start date
2021-02-24
Completion date
2021-12-01
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Pathology, Foot Pathology

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.

Interventions

BEHAVIORALPROMIS 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.

BEHAVIORALPlacebo

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

Sponsors

American Orthopaedic Foot and Ankle Society
CollaboratorUNKNOWN
University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
mean pain interference domain measured by PROMISbaseline, before interventionPROMIS® (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.
mean Patient Activation Measure (PAM)baseline, after interventionOur 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.
percent of participant who respond favorably on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS)baseline, after interventionWe 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 depressionbaseline, before interventionPROMIS® (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.
mean physical functionbaseline, before interventionPROMIS® (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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026