Communication Disabilities Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 1908 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Michigan Medicine | Ann Arbor | Michigan |
United States | University of Illinois Chicago | Chicago | Illinois |
United States | Denver Health | Denver | Colorado |
United States | UCHealth Primary Care - Lone Tree | Lone Tree | Colorado |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Mayo Clinic, Patient-Centered Outcomes Research Institute, University of Illinois at Chicago, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Hospital Admissions | Electronic Health Record data will identify the number of hospital admissions among participating patients. | 6 months | |
Other | Patient Emergency Department (ED) Use | Electronic Health Record data will identify the frequency of ED use among participating patients. | 6 months | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03276559 -
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
|
N/A | |
Recruiting |
NCT05808478 -
Eye-tracking Technology for Severe Communication Disability
|
N/A |