Acute Decompensated Heart FailureNCT03488979
Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen
An observational study of Acute Decompensated Heart Failure, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- educational interventional group
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2015to 1 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients hospitalized on the general inpatient medicine service
- Receiving intravenous diuretics for treatment of acute decompensated heart failure
Who cannot join
- 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
About this study
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.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- educational interventional group
- Keywords
- Heart Failure, Medication Adherence
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventional groupOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Interventional Group | Primary outcome measure: Difference in MOSSAS-3HF score between intervention group and control group, administered 4 weeks after discharge. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days after hospital discharge
Secondary outcomes (2)
survival without need for acute medical care within 30 days
assessed by scripted post-discharge telephone call
Measured: 30 days after discharge
survival without need for acute medical care within 30 days
as assessed by review of electronic medical records
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start16 Mar 2015
- Primary completion31 Aug 2015
- Study completion1 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488979
- Sponsor's protocol ID
- IRB00034300
- Status last verified
- Apr 2018
- First submitted
- 16 Feb 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21807328Martin 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 19114170Goonewardena 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 19356487Parkes 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 18326503Spencer 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 11419879Decara 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Providing Education and Patient's Inferior Vena Cava Ultrasound Images on Adherence to a Heart Failure Regimen
- ClinicalTrials.gov ID
- NCT03488979
- Acronym / sponsor ID
- IRB00034300
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Heart Failure, Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Interventional Group | – | Other: educational interventional groupPrimary outcome measure: Difference in MOSSAS-3HF score between intervention group and control group, administered 4 weeks after discharge. |
| Attention Control Group | – | –Primary outcome measure: Difference in MOSSAS-3HF score between intervention group and control group, administered 4 weeks after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients hospitalized on the general inpatient medicine service
- Receiving intravenous diuretics for treatment of acute decompensated heart failure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational 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. | Other | Educational Interventional Group |
Primary outcome
MOSSAS-3HF score
Time frame: 30 days after hospital discharge
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).
2 secondary outcomes
survival without need for acute medical care within 30 days
Time frame: 30 days after discharge
survival without need for acute medical care within 30 days
Time frame: 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 21807328Fitzgerald 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.
- Background: PubMed 19114170Martin 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.
- Background: PubMed 19356487Goonewardena 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.
- Background: PubMed 18326503Parkes 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.
- Background: PubMed 11419879Spencer 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.
- Background: PubMed 15746716Decara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOSSAS-3HF score (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488979, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.