Heart FailureNCT05297942
Expansion of Abbreviations and Acronyms for Patients
A study testing Expansion of Abbreviations and Acronyms in people with Heart Failure, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Expansion of Abbreviations and Acronyms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Heart Failure
- Being tested
- Expansion of Abbreviations and Acronyms
- Keywords
- Abbreviations, Acronyms, Personal Health Records, Patient Portals, Consumer Health Informatics, Patient Access to Records
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expansion of Abbreviations and AcronymsOther
Expansion of Abbreviations and Acronyms
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Expansion) Arm | Experimental | Expansion of abbreviations and acronyms Receives: Other: Expansion of Abbreviations and Acronyms |
| Control (Abbreviation) Arm | No intervention | No expansion of abbreviations and acronyms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall comprehension
count of the total number of abbreviated or expanded terms comprehended by the each participant
Measured: Day 1, at the time of the intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Feb 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Ruth M Masterson Creber, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297942
- Sponsor's protocol ID
- 1804019182
- Status last verified
- Jun 2022
- First submitted
- 17 Mar 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35560053
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expansion of Abbreviations and Acronyms on Patient Comprehension of Their Health Records: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05297942
- Acronym / sponsor ID
- 1804019182
- Conditions
- Heart Failure
- Keywords
- Abbreviations, Acronyms, Personal Health Records, Patient Portals, Consumer Health Informatics, Patient Access to Records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Expansion) Arm | Experimental | Other: Expansion of Abbreviations and AcronymsExpansion of abbreviations and acronyms |
| Control (Abbreviation) Arm | No intervention | –No expansion of abbreviations and acronyms |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expansion of Abbreviations and AcronymsExpansion of Abbreviations and Acronyms | Other | Intervention (Expansion) Arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Results publication: PubMed 35560053Grossman 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth M Masterson Creber, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expansion of Abbreviations and Acronyms in people with Heart Failure, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall comprehension (time frame: Day 1, at the time of the intervention administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.