NCT05297942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

March 17, 2022

Last Update Submit

June 13, 2022

Conditions

Keywords

AbbreviationsAcronymsPersonal Health RecordsPatient PortalsConsumer Health InformaticsPatient Access to Records

Outcome Measures

Primary Outcomes (1)

  • Overall comprehension

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

    Day 1, at the time of the intervention administration

Study Arms (2)

Intervention (Expansion) Arm

EXPERIMENTAL

Expansion of abbreviations and acronyms

Other: Expansion of Abbreviations and Acronyms

Control (Abbreviation) Arm

NO INTERVENTION

No expansion of abbreviations and acronyms

Interventions

Expansion of Abbreviations and Acronyms

Intervention (Expansion) Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ruth M Masterson Creber, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking not possible due to the nature of the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

February 1, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The trial protocol and statistical analysis plan will be made available upon publication
Access Criteria
Public

Locations