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Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities

Primary Purpose

Communication Disabilities

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthcare team- + patient-directed intervention
Healthcare team-directed intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Communication Disabilities focused on measuring Patient-provider communication, Communication strategies, Healthcare outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Denver Health
  • UCHealth Primary Care - Lone Tree
  • University of Illinois ChicagoRecruiting
  • Michigan Medicine
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthcare team- + patient-directed intervention

Healthcare team-directed intervention

Arm Description

Team education and patient tool

Team education

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 30, 2020
Last Updated
February 1, 2023
Sponsor
University of Colorado, Denver
Collaborators
Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Illinois at Chicago, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04697212
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Illinois at Chicago, University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication Disabilities
Keywords
Patient-provider communication, Communication strategies, Healthcare outcomes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1908 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthcare team- + patient-directed intervention
Arm Type
Experimental
Arm Description
Team education and patient tool
Arm Title
Healthcare team-directed intervention
Arm Type
Active Comparator
Arm Description
Team education
Intervention Type
Behavioral
Intervention Name(s)
Healthcare team- + patient-directed intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthcare team-directed intervention
Intervention Description
Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities.
Primary Outcome Measure Information:
Title
Change in Patient Health-Related Quality of Life
Description
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.
Time Frame
1 week, 6 months
Title
Patient Experience with the Clinical Visit
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Provider Use of Communication Strategies
Description
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.
Time Frame
Baseline
Title
Patient Self-Efficacy for Management of Chronic Conditions
Description
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.
Time Frame
1 week
Title
Provider Satisfaction with Quality of Interaction
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Patient Hospital Admissions
Description
Electronic Health Record data will identify the number of hospital admissions among participating patients.
Time Frame
6 months
Title
Patient Emergency Department (ED) Use
Description
Electronic Health Record data will identify the frequency of ED use among participating patients.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan A Morris, PhD, MPH
Phone
303-724-3535
Email
megan.a.morris@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie A Maertens, PhD
Phone
303-724-7319
Email
julie.maertens@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan A Morris, PhD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan A Morris, PhD, MPH
Email
megan.a.morris@cuanschutz.edu
Facility Name
UCHealth Primary Care - Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan A Morris, PhD, MPH
Email
megan.a.morris@cuanschutz.edu
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Duffecy, PhD
Email
jduffecy@uic.edu
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael M McKee, MD, MPH
Email
mmmckee@med.umich.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Phelan, PhD
Email
phelan.sean@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD at this time.

Learn more about this trial

Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities

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