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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03724695
Other study ID # 831733
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 13, 2018
Est. completion date December 13, 2024

Study information

Verified date October 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

End-of-life (EOL) care for heart failure (HF) patients includes high healthcare utilization and costs, in part due to the lack of integration of optimal HF management and home-based palliative care. In a pilot quality improvement project of clinician "nudges" to enroll seriously ill HF patients in a home-based, integrated HF and palliative care platform, the investigators demonstrated decreased healthcare utilization and costs and increased hospice utilization among seriously ill HF patients. The investigators propose a pragmatic randomized trial for clinicians of seriously ill HF patients admitted to three University of Pennsylvania Health System Hospitals, randomly assigning an opt-in approach (usual care) versus a "nudge" or opt-out approach of a visit from an Advanced Heart Care at Home (AHCAH) liaison to clinicians of eligible patients to discuss and enroll in the AHCAH program, to rigorously and scientifically evaluate clinical, utilization, and cost outcomes among high-risk HF patients at the EOL, and to promote physician uptake of best practices.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 700
Est. completion date December 13, 2024
Est. primary completion date December 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. At least 18 years of age 2. Reside within Caring Way's geographic catchment 3. Heart Failure ICD code from any previous healthcare encounter (inpatient or outpatient) in the 12 months prior to index hospitalization 4. Admitted to a cardiology or hospitalist service 5. Palliative Connect score greater than 0.3 6. Index hospitalization during study period Exclusion Criteria: 1. Less than 18 years of age 2. Pregnant women 3. Incarcerated patients 4. Homeless patients 5. Reside outside of Caring Way's geographic catchment 6. Patients without an identifiable primary physician for AHCAH staff to communicate with as determined by the AHCAH liaison via EPIC 7. Prior hospitalization during study period

Study Design


Intervention

Other:
Clinician nudge or opt out approach for AHCAH liaison visit
This study is a "nudge" or opt-out approach of an AHCAH liaison visit to eligible seriously ill HF patients prior to hospital discharge to discuss the AHCAH program and to subsequently facilitate enrolling them in the AHCAH program if they are amenable, compared to the opt-in approach (usual care).

Locations

Country Name City State
United States Perelman Center for Advanced Medicine Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
University of Pennsylvania Independence Blue Cross, Penn Medicine Center for Health Care Innovation

Country where clinical trial is conducted

United States, 

References & Publications (29)

Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Muss — View Citation

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Department of Homeland Security; Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Social Security Administration; Agency for International Development; Department of Housing and Urban Development; Department of Labor; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; Department of Transportation. Federal Policy for the Protection of Human Subjects. Final rule. Fed Regist. 2017 Jan 19;82(12):7149-274. — View Citation

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Halpern SD, Doyle R, Kawut SM. The ethics of randomized clinical trials in pulmonary arterial hypertension. Proc Am Thorac Soc. 2008 Jul 15;5(5):631-5. doi: 10.1513/pats.200802-019SK. — View Citation

Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA. 2002 Jul 17;288(3):358-62. doi: 10.1001/jama.288.3.358. — View Citation

Halpern SD, Karlawish JH, Casarett D, Berlin JA, Asch DA. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med. 2004 Apr 12;164(7):801-3. doi: 10.1001/archinte.164.7.801. — View Citation

Halpern SD, Karlawish JH, Casarett D, Berlin JA, Townsend RR, Asch DA. Hypertensive patients' willingness to participate in placebo-controlled trials: implications for recruitment efficiency. Am Heart J. 2003 Dec;146(6):985-92. doi: 10.1016/S0002-8703(03)00507-6. — View Citation

Halpern SD, Metzger DS, Berlin JA, Ubel PA. Who will enroll? Predicting participation in a phase II AIDS vaccine trial. J Acquir Immune Defic Syndr. 2001 Jul 1;27(3):281-8. doi: 10.1097/00126334-200107010-00011. — View Citation

Halpern SD, Randolph AG, Angus DC. No child left behind: Enrolling children and adults simultaneously in critical care randomized trials. Crit Care Med. 2009 Sep;37(9):2638-41. doi: 10.1097/CCM.0b013e3181a59357. — View Citation

Halpern SD. Evaluating preference effects in partially unblinded, randomized clinical trials. J Clin Epidemiol. 2003 Feb;56(2):109-15. doi: 10.1016/s0895-4356(02)00598-x. — View Citation

Halpern SD. Evidence-based equipoise and research responsiveness. Am J Bioeth. 2006 Jul-Aug;6(4):1-4. doi: 10.1080/15265160600843528. No abstract available. — View Citation

Halpern SD. Financial incentives for research participation: empirical questions, available answers and the burden of further proof. Am J Med Sci. 2011 Oct;342(4):290-3. doi: 10.1097/MAJ.0b013e3182297925. No abstract available. — View Citation

Halpern SD. Prospective preference assessment: a method to enhance the ethics and efficiency of randomized controlled trials. Control Clin Trials. 2002 Jun;23(3):274-88. doi: 10.1016/s0197-2456(02)00191-5. — View Citation

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Kitamura T, Ohtani M, Ueno A, Niijima T. [Biochemical changes after parathyroidectomy in primary hyperparathyroidism. I. Serial changes of Ca, Mg,P, immunoreactive PTH and nephrogenous c-AMP during 2 weeks after parathyroidectomy (author's transl)]. Nihon Hinyokika Gakkai Zasshi. 1981 Feb;72(2):151-8. No abstract available. Japanese. — View Citation

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Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD, Pauly MV, Schwartz JS. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA. 1999 Feb 17;281(7):613-20. doi: 10.1001/jama.281.7.613. — View Citation

Rey MM, Ware LB, Matthay MA, Bernard GR, McGuire AL, Caplan AL, Halpern SD. Informed consent in research to improve the number and quality of deceased donor organs. Crit Care Med. 2011 Feb;39(2):280-3. doi: 10.1097/CCM.0b013e3181feeb04. — View Citation

Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030. — View Citation

Russo MJ, Gelijns AC, Stevenson LW, Sampat B, Aaronson KD, Renlund DG, Ascheim DD, Hong KN, Oz MC, Moskowitz AJ, Rose EA, Miller LW; REMATCH Investigators. The cost of medical management in advanced heart failure during the final two years of life. J Card Fail. 2008 Oct;14(8):651-8. doi: 10.1016/j.cardfail.2008.06.005. Epub 2008 Jul 21. — View Citation

Sahlen KG, Boman K, Brannstrom M. A cost-effectiveness study of person-centered integrated heart failure and palliative home care: Based on a randomized controlled trial. Palliat Med. 2016 Mar;30(3):296-302. doi: 10.1177/0269216315618544. Epub 2015 Nov 24. — View Citation

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Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. — View Citation

Warraich HJ, Xu H, DeVore AD, Matsouaka R, Heidenreich PA, Bhatt DL, Hernandez AF, Yancy CW, Fonarow GC, Allen LA. Trends in Hospice Discharge and Relative Outcomes Among Medicare Patients in the Get With The Guidelines-Heart Failure Registry. JAMA Cardiol. 2018 Oct 1;3(10):917-926. doi: 10.1001/jamacardio.2018.2678. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Acute care days number of hospitalization days in the University of Pennsylvania Health System 6-12 months
Secondary Mortality number of patient deaths after enrollment in AHCAH 6-12 months
Secondary Hospice enrollment number of patients who transition from AHCAH to hospice 6-12 months
Secondary hospice length of service If transitioned to hospice from AHCAH, number of days on hospice 6-12 months
Secondary University of Pennsylvania Health System total acute care cost cost of emergency department visit and/or hospitalization within the UPHS Health system 6-12 months
Secondary Pennsylvania total acute care cost cost of emergency department visit and/or hospitalization within Pennsylvania 6-12 months
Secondary University of Pennsylvania Health System number of intensive care unit days number of days hospitalized in an intensive care unit within UPHS 6-12 months
Secondary Pennsylvania number of intensive care unit days number of days hospitalized in an intensive care unit within hospitals in Pennsylvania 6-12 months
Secondary University of Pennsylvania Health System emergency department visits number of emergency department visits within UPHS 6-12 months
Secondary Pennsylvania emergency department visits number of emergency department visits within hospitals in Pennsylvania 6-12 months
Secondary Use of intravenous diuretics at home Prescription and delivery of intravenous diuretics from Penn Home Infusion Therapy Services and administration of intravenous diuretics by AHCAH nurse 6-12 months
Secondary new documentation of goals of care Advance Care Planning documentation within electronic medical record 6-12 months
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