- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05297942
Expansion of Abbreviations and Acronyms for Patients
Effect of Expansion of Abbreviations and Acronyms on Patient Comprehension of Their Health Records: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Importance: In 2020, an estimated 100 million Americans accessed their own health records online. That number likely increased beginning April 2021, when U.S. federal rules implemented the 21st Century Cures Act requiring electronic health information to be made freely accessible. Medical abbreviations and acronyms may limit patient understanding of health records. Automated expansion is one potential solution, however, the magnitude of its effect on patient comprehension has not been estimated.
Objective: To estimate the effect of expansion on patient comprehension of abbreviations and acronyms in their health records.
Design: Prospective, two-arm, parallel, individually randomized controlled trial.
Participants: Patients who receive primary care at one of three urban hospitals. A purposive sample representative on age, gender, and race will be enrolled between February 2020 and August 2021. To isolate the main effect, the investigators will include only English-speaking adult patients with diagnosed heart failure.
Intervention: Participants will be randomized to receive clinical text with abbreviations (control group, n=30) or with expansions (intervention group, n=30). The abbreviations and expansions included "hrs" (hours), "MD" (medical doctor), "BP" (blood pressure), "ED" (emergency department), "yo" (year old), "pt" (patient), "HF" (heart failure), "hx" (history), "HTN" (hypertension), "MI" (myocardial infarction).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult (21 years or older)
- Confirmed diagnosis of heart failure
- Able to read and speak English
- Willing and able to provide informed consent
- Receives primary care from participating provider
Exclusion Criteria:
- Healthcare professional (MD, DO, RN, etc.)
- No telephone number or email address
- Severe cognitive impairment or clinical diagnosis of dementia
- Major psychiatric illness, including active psychosis
- Other illness that would preclude participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (Expansion) Arm
Expansion of abbreviations and acronyms
|
Expansion of Abbreviations and Acronyms
|
|
No Intervention: Control (Abbreviation) Arm
No expansion of abbreviations and acronyms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall comprehension
Time Frame: Day 1, at the time of the intervention administration
|
count of the total number of abbreviated or expanded terms comprehended by the each participant
|
Day 1, at the time of the intervention administration
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ruth M Masterson Creber, PhD, Weill Medical College of Cornell University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1804019182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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