Expansion of Abbreviations and Acronyms for Patients

June 13, 2022 updated by: Weill Medical College of Cornell University

Effect of Expansion of Abbreviations and Acronyms on Patient Comprehension of Their Health Records: A Randomized Clinical Trial

This is a prospective, two-arm, parallel, individually randomized controlled trial to estimate the effect of expansion on patient comprehension (primary outcome) of abbreviations and acronyms in their health records. English-speaking adult patients with diagnosed heart failure who receive primary care at three urban hospitals in New York City will be considered. The investigators hypothesize that expansion will significantly increase patient comprehension of abbreviations and acronyms in the health record.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Columbia University

Investigators

  • Principal Investigator: Ruth M Masterson Creber, PhD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

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)?

YES

IPD Plan Description

The proposed study will generate data on comprehension from 60 recently hospitalized patients with advanced heart failure. The final locked dataset will be shared with other investigators or healthcare organizations upon request and without cost. Before the request is fulfilled, the investigator or organization must sign a data-sharing agreement to demonstrate and provide for: (1) a commitment to using the information only for research or clinical purposes and not to identify any individual participant, (2) a commitment to securing the information using appropriate computer technology, (3) a commitment to not share the information outside the immediate research or clinical setting, and (4) a commitment to erasing the data after the analyses are completed.

IPD Sharing Time Frame

The trial protocol and statistical analysis plan will be made available upon publication

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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