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| Name | Class |
|---|---|
| Columbia University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Expansion) Arm | Experimental | Expansion of abbreviations and acronyms |
|
| Control (Abbreviation) Arm | No Intervention | No expansion of abbreviations and acronyms |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expansion of Abbreviations and Acronyms | Other | Expansion of Abbreviations and Acronyms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth M Masterson Creber, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35560053 | Result | 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. |
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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.
The trial protocol and statistical analysis plan will be made available upon publication
Public
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Masking not possible due to the nature of the intervention.
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