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

NCT03488979 | Completed

• 1 other identifier: IRB00034300
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Heart Failure; Medication Adherence

Outcome Measures

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).

  30 days after hospital discharge

Secondary Outcomes (2)

• survival without need for acute medical care within 30 days

  30 days after discharge

• survival without need for acute medical care within 30 days

  30 days after discharge

Study Arms (2)

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

educational interventional group OTHER

• 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.

Educational Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (6)

• 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.

  PMID: 21807328 BACKGROUND

• 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.

  PMID: 19114170 BACKGROUND

• 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.

  PMID: 19356487 BACKGROUND

• 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.

  PMID: 18326503 BACKGROUND

• 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.

  PMID: 11419879 BACKGROUND

• 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.

  PMID: 15746716 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: April 5, 2018
• Study Start: March 16, 2015
• Primary Completion: August 31, 2015
• Study Completion: October 1, 2015
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share