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Expansion of Abbreviations and Acronyms for Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expansion of Abbreviations and Acronyms
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Abbreviations, Acronyms, Personal Health Records, Patient Portals, Consumer Health Informatics, Patient Access to Records

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (Expansion) Arm

Control (Abbreviation) Arm

Arm Description

Expansion of abbreviations and acronyms

No expansion of abbreviations and acronyms

Outcomes

Primary Outcome Measures

Overall comprehension
count of the total number of abbreviated or expanded terms comprehended by the each participant

Secondary Outcome Measures

Full Information

First Posted
March 17, 2022
Last Updated
June 13, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05297942
Brief Title
Expansion of Abbreviations and Acronyms for Patients
Official Title
Effect of Expansion of Abbreviations and Acronyms on Patient Comprehension of Their Health Records: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Abbreviations, Acronyms, Personal Health Records, Patient Portals, Consumer Health Informatics, Patient Access to Records

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Masking not possible due to the nature of the intervention.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Expansion) Arm
Arm Type
Experimental
Arm Description
Expansion of abbreviations and acronyms
Arm Title
Control (Abbreviation) Arm
Arm Type
No Intervention
Arm Description
No expansion of abbreviations and acronyms
Intervention Type
Other
Intervention Name(s)
Expansion of Abbreviations and Acronyms
Intervention Description
Expansion of Abbreviations and Acronyms
Primary Outcome Measure Information:
Title
Overall comprehension
Description
count of the total number of abbreviated or expanded terms comprehended by the each participant
Time Frame
Day 1, at the time of the intervention administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth M Masterson Creber, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35560053
Citation
Grossman Liu L, Russell D, Reading Turchioe M, Myers AC, Vawdrey DK, Masterson Creber RM. Effect of Expansion of Abbreviations and Acronyms on Patient Comprehension of Their Health Records: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212320. doi: 10.1001/jamanetworkopen.2022.12320.
Results Reference
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Expansion of Abbreviations and Acronyms for Patients

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