NCT04947878

Brief Summary

Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 13, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

June 13, 2021

Last Update Submit

September 27, 2021

Conditions

Musculoskeletal Diseases

Keywords

Orthopedics

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict Scale

    Questionnaire assessing decision conflict

    Baseline

Secondary Outcomes (3)

  • Jefferson Scale of Patient's Perceptions of Physician Empathy

    Baseline

  • Patient Activation Measure-13

    Baseline

  • Satisfaction scale

    Baseline

Study Arms (2)

Standard care

NO INTERVENTION

will not review a prompt list before their visit.

Prompt list

EXPERIMENTAL

The patients in the intervention group will review a prompt list before their visit.

Other: Prompt list

Interventions

Prompt listOTHER

The patients in the intervention group will review a prompt list before their visit.

Prompt list

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18+)
  • Orthopedic visit

You may not qualify if:

  • Patients who are illiterate.
  • Patients who do not speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT health Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • David Ring, MD, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to enroll. Randomization will be done through an Excel random number generator. The patients in the intervention group will review a prompt list before their visit. The research assistant will shadow the surgeon to count the amount of questions they ask during their visit. Patients in both groups will fill out a survey entailing demographics, the Decisional Conflict Scale, the JSPPE, the PAM score and a satisfaction scale at the end of the visit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Ring, MD, PhD Associate Dean for Comprehensive Care, Professor of Surgery and Psychiatry

Study Record Dates

First Submitted

June 13, 2021

First Posted

July 1, 2021

Study Start

July 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)