Clinical trial NCT04697212: Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities
Official title: Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities: The INTERACT Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Communication Disabilities
Keywords: Patient-provider communication
Communication strategies
Healthcare outcomes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Mayo Clinic
name: University of Illinois at Chicago
name: University of Michigan
First posted: 2021-01-06
Enrollment: 1908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient Health-Related Quality of Life
timeFrame: 1 week, 6 months
measure: Patient Experience with the Clinical Visit
timeFrame: Baseline
Secondary outcomes:
measure: Provider Use of Communication Strategies
timeFrame: Baseline
measure: Patient Self-Efficacy for Management of Chronic Conditions
timeFrame: 1 week
measure: Provider Satisfaction with Quality of Interaction
timeFrame: Baseline
Other outcomes:
measure: Patient Hospital Admissions
timeFrame: 6 months
measure: Patient Emergency Department (ED) Use
timeFrame: 6 months
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Lone Tree
country: United States
facility: UCHealth Primary Care - Lone Tree
state: Colorado
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of Colorado, Denver
name: Megan A Morris, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: