Expansion of Abbreviations and Acronyms for Patients

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT05297942

Collaborator

Columbia University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Expansion of Abbreviations and Acronyms	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Masking not possible due to the nature of the intervention.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall comprehension [Day 1, at the time of the intervention administration]
count of the total number of abbreviated or expanded terms comprehended by the each participant

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

Weill Medical College of Cornell University
Columbia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT05297942

Other Study ID Numbers:

1804019182

First Posted:

Mar 28, 2022

Last Update Posted:

Jun 16, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Weill Medical College of Cornell University

Abbreviations

Acronyms

Personal Health Records

Patient Portals

Consumer Health Informatics

Patient Access to Records

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jun 16, 2022