Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities

Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities: The INTERACT Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Communication Disabilities
• Intervention / Treatment: Behavioral: Healthcare team- + patient-directed intervention; Behavioral: Healthcare team-directed intervention

Detailed Description

About 40 million people have a communication disability (CD), which includes hearing, speech, language, and voice disabilities. Compared to non-disabled patients, patients with CD are more likely to have a greater number of chronic conditions, and have higher rates of asthma, hypertension, emphysema, cardiovascular disease, diabetes and arthritis. Approximately one third of people with CD report the quality of their health as fair/poor as compared to only 11% of patients without CD. Patients with CD are 2-4 times more likely to report difficulty finding a provider than those without CD. When they do access care, they report that the quality of care and communication they receive is low.

Communication strategies that patients with CD require may vary, and providers need to elicit and then adapt to patients' preferences for communication strategies. Provider education and patient-prompt tool interventions have demonstrated effectiveness in general populations. Provider communication education significantly improves their patient-centered communication. Patient-prompt tools empower patients to identify topics and communication styles they prefer and then share this information with their healthcare provider. While provider education and patient-prompt tools have been proven effective, their effectiveness has not been compared in the primary care setting for patients with CD. Therefore, the aim of this study is to adapt these two types of interventions for patients with CD in the primary care setting and then compare their effectiveness at improving patient-reported health related quality of life and experience with care.

In this study we will conduct a stepped-wedge randomized control trial design. The study will take place at 4 sites that have unique contributions that will add to the generalizability and dissemination of the results. They are diverse in their geographic location, include academic and community clinics, represent urban and suburban locations, and include racially and ethnically diverse patients. Eight clinics, 2 at each site, will be part of the trial.

All participating clinic sites will receive the healthcare team-directed intervention (intervention A) and then will be randomized as to when they begin implementing the patient-directed tool (intervention B). The A versus A+B study design ensures all participating healthcare team members receive the training, as national policies require healthcare team members receive training on effective communication with patients with CD. We will randomize at the clinic-level cluster to eliminate spillover intervention effects amongst providers within the same clinic.

Participating healthcare team members will all receive the healthcare team-directed intervention (a general overview training about communication disabilities and communication strategies that can be used with patients) during the month preceding trial roll-out. Clinics will be randomized as to when they begin implementing the patient-directed tool, with a new clinic beginning every two months. One month prior to implementation, the healthcare team members will receive a booster education training, be introduced to the patient-directed tool, and alerted that they will be handed the completed tool by patients with CD during the patients' clinical encounters.

To measure patient and provider perceptions, both groups will complete a survey after the clinical encounter. A subset of encounters will be videotaped, and content analysis will document providers' use of patient-centered strategies and any adaptations made to the intervention strategies. Chart review will document patients' healthcare utilization over time. To understand providers' experiences with both interventions and perceptions of feasibility, healthcare team members will participate in qualitative focus groups and interviews at 3 time points.

The outcomes from this study may help create patient and provider training and tools that, if proven successful, could be disseminated to other healthcare arenas to improve patient-provider communication and ultimately improved health outcomes for this vulnerable population.

• Study Type: Interventional
• Enrollment (Anticipated): 1908
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan A Morris, PhD, MPH; Phone Number: 303-724-3535; Email: megan.a.morris@cuanschutz.edu
• Study Contact Backup: Name: Julie A Maertens, PhD; Phone Number: 303-724-7319; Email: julie.maertens@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80205
      • Not yet recruiting
      • Denver Health
      • Contact: Megan A Morris, PhD, MPH; Email: megan.a.morris@cuanschutz.edu
    • Lone Tree, Colorado, United States, 80124
      • Not yet recruiting
      • UCHealth Primary Care - Lone Tree
      • Contact: Megan A Morris, PhD, MPH; Email: megan.a.morris@cuanschutz.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Contact: Jenna Duffecy, PhD; Email: jduffecy@uic.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Not yet recruiting
      • Michigan Medicine
      • Contact: Michael M McKee, MD, MPH; Email: mmmckee@med.umich.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Sean Phelan, PhD; Email: phelan.sean@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthcare team- + patient-directed intervention; Team education and patient tool	Behavioral: Healthcare team- + patient-directed intervention; 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.; Behavioral: Healthcare team-directed intervention; Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities.
Active Comparator: Healthcare team-directed intervention; Team education	Behavioral: Healthcare team-directed intervention; Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Use of Communication Strategies	Providers' use of patient-centered communication and strategies will be measured through a content analysis of video-recorded clinical encounters of a subset of patients. The recorded video will be analyzed using the Roter Interaction Analysis System (RIAS), which is a coding system that will yield the ratio of the degree of patient-centered communication in the clinical encounter.	Baseline
Patient Self-Efficacy for Management of Chronic Conditions	One week following the clinical encounter, patients will complete the PROMIS Global Health measure, which includes 8 items that measure Self-Efficacy for Management of Chronic Conditions. The measure includes items that ask about patients' self-efficacy for managing medications, treatments, and symptoms.	1 week
Provider Satisfaction with Quality of Interaction	Providers' perceptions of the communication will be measured using the Physician Satisfaction with Primary Care Office Visits survey, which has been used concurrently with the RIAS coding system to assess providers' perspectives of communication with diverse populations. The survey includes 20 items on a Likert scale.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Hospital Admissions	Electronic Health Record data will identify the number of hospital admissions among participating patients.	6 months
Patient Emergency Department (ED) Use	Electronic Health Record data will identify the frequency of ED use among participating patients.	6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Patient-Centered Outcomes Research Institute; Mayo Clinic; University of Michigan; University of Illinois at Chicago
• Investigators: Principal Investigator: Megan A Morris, PhD, MPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Patient-provider communication; Communication strategies; Healthcare outcomes
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders
• Other Study ID Numbers: 20-3148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No