Clinical trial NCT03488979: Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen
Official title: Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
Keywords: Heart Failure
Medication Adherence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, non-pregnant patients admitted on a general inpatient medicine service of an urban, academic medical center, receiving intravenous diuretics for the treatment of acute decompensated heart failure.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized on the general inpatient medicine service
* Receiving intravenous diuretics for treatment of acute decompensated heart failure

Exclusion Criteria:

* Pregnancy
* Inability or unwillingness to provide informed consent
* Inability to read or speak English
* Without access to a working telephone number
* Recent abdominal surgery or current symptom of severe abdominal pain that would interfere with patient tolerance of pressure from an ultrasound probe

Primary outcomes:
measure: MOSSAS-3HF score
timeFrame: 30 days after hospital discharge
Secondary outcomes:
measure: survival without need for acute medical care within 30 days
timeFrame: 30 days after discharge
measure: survival without need for acute medical care within 30 days
timeFrame: 30 days after discharge
Other outcomes:
Locations:
Study officials:
References:
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