PROMs To Improve Care- Standardized vs Patient Specific

NCT04027569 | Withdrawn

• 1 other identifier: 52021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.

Conditions

Hand Injuries

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale (DCS)

  DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions.

  Immediately after the clinical encounter, same day as clinical encounter

Study Arms (2)

PSFS group

ACTIVE COMPARATOR

Patients in this arm will complete the patient specific functional scale (PSFS) during their visits

Other: Patient Specific Functional Scale

PROMIS PF group

EXPERIMENTAL

Patients in this arm will complete the PROMIS Physical Function during their visits

Other: PROMIS PF

Interventions

Patient Specific Functional Scale OTHER

A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.

PSFS group

PROMIS PF OTHER

A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.

PROMIS PF group

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• hand surgery patients over age 18, english fluency and literacy, able to take informed consent

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Robin N Kamal, MD MBA

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start (Estimated): November 1, 2040
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share