Communication DisabilitiesNCT04697212
Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities
A study testing Healthcare team- + patient-directed intervention and Healthcare team-directed intervention in people with Communication Disabilities, run by University of Colorado, Denver at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication Disabilities
- What is being tested?
- Healthcare team- + patient-directed intervention and Healthcare team-directed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 687 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Dec 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient participants: Individuals without a communication disability
- Healthcare team participants: Individuals who do not work at participating study sites
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Michigan Medicine
Ann Arbor, Michigan, 48104
University of Illinois Chicago
Chicago, Illinois, 60612
Denver Health
Denver, Colorado, 80205
UCHealth Primary Care - Lone Tree
Lone Tree, Colorado, 80124
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Communication Disabilities
- Being tested
- Healthcare team- + patient-directed intervention, Healthcare team-directed intervention
- Keywords
- Patient-provider communication, Communication strategies, Healthcare outcomes
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare team- + patient-directed interventionBehavioural
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-directed interventionBehavioural
Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare team- + patient-directed intervention | Experimental | Team education and patient tool Receives: Behavioral: Healthcare team- + patient-directed intervention; Behavioral: Healthcare team-directed intervention |
| Healthcare team-directed intervention | Active comparator | Team education Receives: Behavioral: Healthcare team-directed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start13 Dec 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication DisabilitiesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Illinois Chicago, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Megan A Morris, PhD, MPH, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697212
- Sponsor's protocol ID
- 20-3148
- Status last verified
- Nov 2025
- First submitted
- 30 Dec 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities: The INTERACT Trial
- ClinicalTrials.gov ID
- NCT04697212
- Acronym / sponsor ID
- 20-3148
- Conditions
- Communication Disabilities
- Keywords
- Patient-provider communication, Communication strategies, Healthcare outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Illinois Chicago, University of Michigan
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare team- + patient-directed intervention | Experimental | Behavioral: Healthcare team- + patient-directed intervention, Behavioral: Healthcare team-directed interventionTeam education and patient tool |
| Healthcare team-directed intervention | Active comparator | Behavioral: Healthcare team-directed interventionTeam education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patient participants: Individuals without a communication disability
- Healthcare team participants: Individuals who do not work at participating study sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthcare team- + patient-directed interventionParticipants 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. | Behavioural | Healthcare team- + patient-directed intervention |
| Healthcare team-directed interventionParticipants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities. | Behavioural | Healthcare team- + patient-directed intervention, Healthcare team-directed intervention |
Primary outcome
Change in Patient Health-Related Quality of Life
Time frame: 1 week, 6 months
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
Time frame: Baseline
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.
3 secondary outcomes
Provider Use of Communication Strategies
Time frame: Baseline
Patient Self-Efficacy for Management of Chronic Conditions
Time frame: 1 week
Provider Satisfaction with Quality of Interaction
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. No plan to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan A Morris, PhD, MPH principal investigator
New York University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthcare team- + patient-directed intervention and Healthcare team-directed intervention in people with Communication Disabilities, run by University of Colorado, Denver at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health-Related Quality of Life (time frame: 1 week, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.