NCT05268055

Brief Summary

The goal of this research is to create a training film for hearing healthcare providers to teach them how to competently and sensitively interact with Deaf patients. In Year 1, focus groups will be facilitated to elicit feedback that will inform video production of the training film. In Year 2, film production will take place, as well as a randomized clinical trial (RCT) to test the feasibility and preliminary efficacy of the new training intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

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

February 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

February 23, 2022

Results QC Date

September 25, 2024

Last Update Submit

November 1, 2024

Conditions

Cultural Competency

Keywords

informed consentsimulationDeafcultural competence

Outcome Measures

Primary Outcomes (3)

  • Healthcare Provider Cultural Competency

    A validated scale used to measure provider cultural competence. Total scores range from 9 to 63, with higher scores indicative of higher levels of cultural competency.

    post-intervention, up to one month

  • Ask, Understand, Remember Assessment

    A validated scale used to measure participants' communication skill. Total scores range from 4 to 16, with higher scores indicating better communication skills.

    post-intervention, up to one month

  • Wake Forest Physician Trust Scale

    A validated scale used to measure the ability to build trust with the standardized patient/participant. Total scores range from 10 to 50, with higher scores indicating greater ability to build trust.

    post-intervention, up to one month

Secondary Outcomes (2)

  • Assessment of Intervention Understanding & Retention

    post-intervention, up to one month

  • Self-Rating of Simulation

    post-intervention, up to one month

Study Arms (2)

"Sign Here" training intervention

EXPERIMENTAL

Participants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers.

Other: "Sign Here" training intervention

Intervention as usual

OTHER

Participants randomized to intervention as usual will review "Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf)

Other: Intervention as usual

Interventions

"Sign Here" training interventionOTHER

Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings.

"Sign Here" training intervention
Intervention as usualOTHER

"Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf)

Intervention as usual

Eligibility Criteria

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

You may qualify if:

  • age 18+
  • self-identification as a healthcare provider, medical student, or nursing student
  • current or recent engagement in informed consent for treatment
  • access to an informed consent form that can be used for a simulated informed consent session
  • We will also screen participants' self-reported level of experience with Deaf people, as we aim to recruit participants with little-to-no prior experience interacting with Deaf people to reflect the most probable real-word encounter that a Deaf person would have when receiving healthcare services.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Small sample size may have affected the power of our statistical analyses.

Results Point of Contact

Title
Melissa L. Anderson, PhD
Organization
UMass Chan Medical School
melissa.anderson@umassmed.edu
508-856-5820

Study Officials

  • Melissa L Anderson

    melissa.anderson@umassmed.edu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 7, 2022

Study Start

May 3, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 27, 2024

Results First Posted

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)