Development and Validation of an Orthopedic Visit Prompt... | NCT04947878

Studies
Development and Validation of an Orthopedic Visit Prompt List

NCT04947878

Sponsor

University of Texas at Austin

Status

Completed

Last Update Posted

Sep 28, 2021Actual

Enrollment

128Actual

Phase

Not Applicable

Conditions

Musculoskeletal Diseases

Interventions

Prompt list

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Jun 13, 2021

First Submission Date that Met QC Criteria

Jun 23, 2021

First Posted Date

Jul 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2021

Last Update Posted Date

Sep 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Ring, David Ring, MD, PhD Associate Dean for Comprehensive Care, Professor of Surgery and Psychiatry, University of Texas at AustinPrincipal Investigator

Lead Sponsor

University of Texas at AustinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Visiting a doctor with a musculoskeletal problem can be quite a daunting experience for patients. A visit question prompt list may help to empower patients and increase their role in active decision-making. Previous studies have shown that patient activation is correlated with a disability, pain intensity, and satisfaction with treatment. Perceived empathy is strongly associated with satisfaction among people with arm problems. A list that prompts patients to ask about things that matter to them, might improve their connection with the surgeon and their perceived empathy. The 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Prompt list	Other	The patients in the intervention group will review a prompt list before their visit.	Prompt list

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decisional Conflict Scale	Questionnaire assessing decision conflict	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Jefferson Scale of Patient's Perceptions of Physician Empathy	Patient perceived of physician empathy as measured by the JSPPE	Baseline
Patient Activation Measure-13	Patient activation as measured by PAM-13

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (18+)
Orthopedic visit

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Ring, MD, PhD	The University of Texas at Austin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT health Austin		Austin	Texas	78712	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.