ClinicalTrials.gg
CompletedNCT03488979Updated Apr 5, 2018

Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen

An observational study in Acute Decompensated Heart Failure, sponsored by Johns Hopkins University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Johns Hopkins University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acute Decompensated Heart Failure

Keywords

  • Heart Failure
  • Medication Adherence
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Inability or unwillingness to provide
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Educational Interventional Group

    Primary outcome measure: Difference in MOSSAS-3HF score between intervention group and control group, administered 4 weeks after discharge.

    Other: educational interventional group

  • Attention Control Group

    Primary outcome measure: Difference in MOSSAS-3HF score between intervention group and control group, administered 4 weeks after discharge.

Interventions

  • Othereducational interventional group

    • Patient Education Tool (Appendix 3) and the patient's own IVC images will be shared with each patient in the intervention group in real time. If feasible, each intervention patient will also receive a printed copy of his or her IVC image.

06

What researchers measure

Primary outcomes

  1. MOSSAS-3HF score

    The MOSSAS-3HF instrument is a 3-item questionnaire that assesses patient self-reported adherence to a heart failure treatment regimen over the past 4 weeks. Minimum score is 0 (adherence none of the time) and maximum score is 15 (adherence all of the time).

    Time frame: 30 days after hospital discharge

Secondary outcomes

  1. survival without need for acute medical care within 30 days

    assessed by scripted post-discharge telephone call

    Time frame: 30 days after discharge

  2. survival without need for acute medical care within 30 days

    as assessed by review of electronic medical records

    Time frame: 30 days after discharge

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Fitzgerald AA, Powers JD, Ho PM, Maddox TM, Peterson PN, Allen LA, Masoudi FA, Magid DJ, Havranek EP. Impact of medication nonadherence on hospitalizations and mortality in heart failure. J Card Fail. 2011 Aug;17(8):664-9. doi: 10.1016/j.cardfail.2011.04.011. Epub 2011 Jun 23. PubMed 21807328 ↗
  • Martin LD, Howell EE, Ziegelstein RC, Martire C, Whiting-O'Keefe QE, Shapiro EP, Hellmann DB. Hand-carried ultrasound performed by hospitalists: does it improve the cardiac physical examination? Am J Med. 2009 Jan;122(1):35-41. doi: 10.1016/j.amjmed.2008.07.022. PubMed 19114170 ↗
  • Goonewardena SN, Gemignani A, Ronan A, Vasaiwala S, Blair J, Brennan JM, Shah DP, Spencer KT. Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure. JACC Cardiovasc Imaging. 2008 Sep;1(5):595-601. doi: 10.1016/j.jcmg.2008.06.005. PubMed 19356487 ↗
  • Parkes G, Greenhalgh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ. 2008 Mar 15;336(7644):598-600. doi: 10.1136/bmj.39503.582396.25. Epub 2008 Mar 6. PubMed 18326503 ↗
  • Spencer KT, Anderson AS, Bhargava A, Bales AC, Sorrentino M, Furlong K, Lang RM. Physician-performed point-of-care echocardiography using a laptop platform compared with physical examination in the cardiovascular patient. J Am Coll Cardiol. 2001 Jun 15;37(8):2013-8. doi: 10.1016/s0735-1097(01)01288-8. PubMed 11419879 ↗
  • Decara JM, Kirkpatrick JN, Spencer KT, Ward RP, Kasza K, Furlong K, Lang RM. Use of hand-carried ultrasound devices to augment the accuracy of medical student bedside cardiac diagnoses. J Am Soc Echocardiogr. 2005 Mar;18(3):257-63. doi: 10.1016/j.echo.2004.11.015. PubMed 15746716 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Aug 2015, 5 months.

Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's 5 months is below that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2018
First posted
Apr 5, 2018
StartActual
Mar 16, 2015
Primary completionActual
Aug 31, 2015
CompletionActual
Oct 1, 2015
Last update
Apr 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03488979
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Mar 16, 2015
Primary completion
Aug 31, 2015
Completion
Oct 1, 2015
Last update
Apr 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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