NCT04343027

Brief Summary

Patients in the orthopedic surgery clinic routinely fill out a patient- reported outcome measurement survey prior to their visit. These scores are stored in Epic, but are not routinely reviewed with patients during their office visit. Study subjects will be randomly assigned into one of two groups: those who have their patient- reported outcome measurements reviewed with them by their physician, and those who will not have their patient-reported outcome measurements reviewed during the visit. Following the visit, patients will complete a patient satisfaction survey.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

April 9, 2020

Last Update Submit

December 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in participants' satisfaction

    Participants' satisfaction will be measured by completing a patient satisfaction survey. This patient satisfaction survey is a modified version of the Press-Ganey Outpatient Medical Practice 10-question survey. The patient satisfaction survey scores will then be compared between the two groups to quantify the effect of reviewing of patient-reported outcome measurements with patients on their satisfaction with the office visit.

    1 day (Visit 1)

Study Arms (2)

Standard of care group

NO INTERVENTION

Participants who did not have their physicians review their patient-reported outcome measurements with them during the office visit.

Consultation group

EXPERIMENTAL

Participants who had their physicians review their patient-reported outcome measurements reviewed with them during the office visit.

Behavioral: Review

Interventions

ReviewBEHAVIORAL

Physicians will review patient-reported outcome measurements with their patients during office visits.

Consultation group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Ages 18 and 100 years
  • Men and women will be included in this study
  • Willing and able to provide consent
  • Able to communicate in English

You may not qualify if:

  • Patients whose visit is related to workman's compensation, a disability claim, or a "no-fault" case (i.e. a law suit related to personal injury)
  • Patients that do not complete the patient satisfaction survey following their visit
  • Patient with mental disabilities or other handicap that would interfere with their capability of completing the surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andrew Rokito, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

August 1, 2022

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
condition of awards and agreements supporting the research.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Upon reasonable request. Requests should be directed to andrew.rokito@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.