PROMs To Improve Care- Standardized vs Patient Specific

PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Hand Injuries
• Intervention / Treatment: Other: Patient Specific Functional Scale; Other: PROMIS PF

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PSFS group; Patients in this arm will complete the patient specific functional scale (PSFS) during their visits	Other: Patient Specific Functional Scale; A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.
Experimental: PROMIS PF group; Patients in this arm will complete the PROMIS Physical Function during their visits	Other: PROMIS PF; A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Robin N Kamal, MD MBA, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2040
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: 52021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No