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
Verified date | April 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 1, 2015 |
Est. primary completion date | August 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Johns Hopkins University |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | survival without need for acute medical care within 30 days | assessed by scripted post-discharge telephone call | 30 days after discharge | |
Secondary | survival without need for acute medical care within 30 days | as assessed by review of electronic medical records | 30 days after discharge |
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