PROMs To Improve Care- Standardized vs Patient Specific

August 6, 2021 updated by: Robin Kamal, Stanford University

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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Immediately after the clinical encounter, same day as clinical encounter
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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

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)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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