Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities

NCT04697212 | Completed DMC

• 1 other identifier: 20-3148
• Study Type: interventional
• Target: 687
• Locations: 1 country
• Sites: 5

Brief Summary

In the United States, 14% of all adults report a speech, language, voice, and/or hearing disability (collectively known as communication disabilities, CD). Patients with CD, experience inequities in receipt of and access to high-quality healthcare services, including primary care. Poor patient-provider communication is a significant contributor to these disparities. When healthcare providers use evidence-based communication strategies, patients with CD have improved communication outcomes and satisfaction. Unfortunately, providers rarely use the strategies in practice. The objective of this study is to compare the effectiveness and implementation of two interventions to increase primary care providers' use of communication strategies, improving the quality of their communication with patients with CD. Using a stepped-wedge study design and guided by the RE-AIM framework, we will compare a healthcare team-directed intervention (training) to a healthcare team-directed intervention + patient-directed intervention (patient-prompt list). In the healthcare team-directed intervention, the team will receive training on evidence-based communication strategies for patients with CD. In the patient-directed intervention, patients with CD will complete a "patient prompt" list that elicits strategies that they prefer the healthcare team to use during their visit. The primary aim of the study is to compare the effectiveness of the interventions on patient-reported experience in primary care practices across 4 healthcare systems using a stepped-wedge randomized controlled trial. Hypothesis 1: Patients with CD will report a higher quality of health, more positive experience, and greater self-efficacy when they use the patient-directed tool (intervention A+B) as compared to patients with CD in the healthcare team education-only phase (intervention A). Hypothesis 2. Providers will use more patient-centered communication and strategies with the patient-directed intervention. The second aim is to examine the adoption, implementation, and short-term sustainability of the interventions.

Conditions

Communication Disabilities

Keywords

Patient-provider communication; Communication strategies; Healthcare outcomes

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health-Related Quality of Life

  One week following their clinical encounter, patients will complete the PROMIS Global Health measure, which includes 10 items that measure Health-Related Quality of Life. The measure includes items that ask the patient to rate their pain, fatigue and emotional wellbeing for the past 7 days. We will ask these questions again 6 months after the clinical encounter.

  1 week, 6 months

• Patient Experience with the Clinical Visit

  Following their clinical encounter, patients will complete 2 subscales of the Patients' Perceptions of Quality of Care (PPQC) survey; Providers' Bedside Manner and Providers' work. Both subscales include questions about the quality of communication with their provider during their appointment. The PPQC has been demonstrated to detect differences in experience between patients with and without disabilities in the primary care setting.

  Baseline

Secondary Outcomes (3)

• Provider Use of Communication Strategies

  Baseline

• Patient Self-Efficacy for Management of Chronic Conditions

  1 week

• Provider Satisfaction with Quality of Interaction

  Baseline

Other Outcomes (2)

• Patient Hospital Admissions

  6 months

• Patient Emergency Department (ED) Use

  6 months

Study Arms (2)

Healthcare team- + patient-directed intervention

EXPERIMENTAL

Team education and patient tool

Behavioral: Healthcare team- + patient-directed intervention; Behavioral: Healthcare team-directed intervention

Healthcare team-directed intervention

ACTIVE COMPARATOR

Team education

Behavioral: Healthcare team-directed intervention

Interventions

Healthcare team- + patient-directed intervention BEHAVIORAL

Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities, and will also complete a "patient prompt" list that elicits strategies that they prefer the healthcare team to use during their visit.

Healthcare team- + patient-directed intervention

Healthcare team-directed intervention BEHAVIORAL

Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities.

Healthcare team- + patient-directed intervention; Healthcare team-directed intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient participants: Individuals with a communication disability who receive care at participating study sites
• Healthcare team participants: Healthcare staff and providers at participating study sites

You may not qualify if:

• Patient participants: Individuals without a communication disability
• Healthcare team participants: Individuals who do not work at participating study sites

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Mayo Clinic: collaborator
• University of Illinois at Chicago: collaborator
• University of Michigan: collaborator

Study Sites (5)

Denver Health

Denver, Colorado, 80205, United States

Location

UCHealth Primary Care - Lone Tree

Lone Tree, Colorado, 80124, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Michigan Medicine

Ann Arbor, Michigan, 48104, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Communication Disorders

Interventions

Patient Care Team

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Study Officials

• Megan A Morris, PhD, MPH

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 6, 2021
• Study Start: December 13, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)