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NCT04697212 · ClinicalTrials.gov registry record · NA
Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 687
- Enrollment target
NCT04697212: Completed NA study, sponsored by University of Colorado, Denver.
NCT04697212 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 687 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697212, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 687 participants
- Enrollment target
Study 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 s
Primary Outcome
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.
Interventions
- BEHAVIORAL Healthcare team- + patient-directed intervention
- BEHAVIORAL Healthcare team-directed intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 687 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2024-02-28 |
| Phase | NA |
What the finished NCT04697212 record still lists
NCT04697212 is an interventional study that assigns participants to a tested intervention. The registered 687 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Healthcare team- + patient-directed intervention is the first listed.
NCT04697212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04697212 about?
NCT04697212 is a clinical study titled "Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities". 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-provi...
What is the current status of trial NCT04697212?
This trial is currently completed. It is a NA study. The enrollment target is 687 participants. The study started on 2021-12-13. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT04697212?
The interventions under investigation include: Healthcare team- + patient-directed intervention (BEHAVIORAL), Healthcare team-directed intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04697212?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04697212's enrollment target sits among peer trials
687 151st of 2000 higher than 1,850 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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