Acute Decompensated Heart Failure Clinical Trial
Official title:
Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen
Heart failure is a common, costly, and disabling condition characterized by recurrent
exacerbations. Episodes of acute decompensated heart failure (ADHF) account for the largest
proportion of admissions and 30-day readmissions to US hospitals. Medication nonadherence and
dietary/fluid nonadherence have been associated with re-admissions. Hand-carried ultrasound
(HCU) devices are portable, relatively inexpensive, and can augment the physical exam in the
assessment of volume status. Dilated Inferior Vena Cava (IVC) with poor collapsibility
correlates with elevated central venous pressure, which may be correlated with earlier
readmission for ADHF.
Study design to measure maximum IVC diameter (IVC max) in mm and the degree of IVC
collapsibility with inspiration on qualitative assessment in approximately 100 patients
admitted with ADHF. The co-investigator will share the IVC images and interpretation with
educational intervention group patients in real time; IVC images and interpretation will not
be shared with control group patients. Study team will assess whether sharing these IVC
measurements correlates with greater adherence to heart failure self-management after
discharge, as measured by the administration of the Medical Outcomes Study Specific Adherence
Scale, modified to a 3-item version relevant for patients with heart failure (MOSSAS-3HF) at
4 weeks after discharge. Study team will also assess for any difference in 30-day readmission
rates for intervention vs. control group patients.
The following list indicates the sequence and timing of our study procedures:
- Inpatients will be screened for study eligibility by one of the co-investigators via
review of the electronic medical record (EMR) for administration of intravenous (IV)
diuretics and documentation of acute decompensated heart failure (ADHF) as the
indication for diuresis.
- Eligible patients will be invited to participate by a research assistant.
- All consenting patients' demographic data will be recorded. A Study Identification
Number will be assigned and personal identifiers will be logged in a "key" separate from
the dataset. The number of subjects who are approached but decline enrollment will be
documented.
- Baseline adherence to heart failure self-management regimen will be assessed by
administration of the Medical Outcomes Study Specific Adherence Scale, a 3-item
questionnaire for patients with heart failure (MOSSAS-3HF). The 3 questions in the
MOSSAS-3HF ask patients to rate how often in the past 4 weeks they adhered to their
medication regimen, low-salt diet, and daily weight measurement. Answer choices for each
of the 3 items range from 0 (none of the time) to 5 (all of the time), so a maximum
total score would be 15, for adherence "all of the time" to each of the 3 items.
Baseline health beliefs regarding benefits of treatments for heart failure and
self-efficacy will be assessed.
- Patients who consent will be randomized into attention control group or educational
intervention group using sealed envelopes (randomization generated in sets of 6 for a
total of one hundred participants by using Research Randomizer).
- All participants will undergo a limited bedside HCU examination of the inferior vena
cava.
- A patient education tool and the patient's own IVC images will be shared with each
patient in the intervention group in real time.
- All images will be acquired by an experienced registered board certified
ultrasonographer between 36 and 60 hours after admission using an HCU device by
Sonosite®.
- Each HCU examination is estimated to last 3-10 minutes. All IVC studies will be
performed with the patient in the supine position using the HCU machine (Sonosite Inc.,
Washington). Ultrasound probe will be at subxyphoid placement. Measurements will be
taken using 2-D images at approximately 2 cm from the IVC/right atrium juncture, taking
care to avoid any hepatic veins emptying into the IVC at the approximation of IVC/ right
atrium interface. The IVC normally collapses with inspiration and expands with
expiration. For this reason, patients may be asked to "sniff" to measure IVC
collapsibility with inspiration.
- For patients under isolation precautions, standard hospital disinfectant procedures as
recommended by the manufacturer and as followed by echocardiography department will be
followed.
- The ultrasonographer will calculate and document the patient's IVC max and qualitative
Inferior Vena Cava Collapsibility Index (IVCCI).
- Two weeks after discharge, a follow up phone call will be made to the all participants.
The scripted phone call for intervention patients will reinforce heart failure
self-management education from the Patient Education Tool. The scripted phone call for
control patients will only ask neutral questions about progress since hospital discharge
and whether the patient remembers getting an ultrasound in the hospital as part of the
research study.
- A phone call will be made and a letter will be mailed to the participants approximately
3 weeks after the study enrollment date to serve as a reminder for the final 30-day
phone call.
- A research assistant will contact all enrolled patients by telephone 4 weeks after
discharge to administer MOSSAS-3HF and to ask whether the patient required hospital
admission or emergency department care since the original hospital discharge where
patient was enrolled in the study.
- Review of electronic medical records will be used to determine length of stay and
whether patients were readmitted to Johns Hopkins Bayview Medical Center or Johns
Hopkins Hospital within 30 days; for those patients not readmitted within 30 days, an
attempt will be made to determine whether the patient has been readmitted to another
hospital or sought care at another Emergency Department during the follow up telephone
call.
- All HCU examinations will be recorded and available for review by a board-certified
cardiologist.
- If an enrolled patient requests termination of the HCU examination at any time, it will
stop immediately.
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