Advanced Heart Care at Home

Heart Failure Clinical Trial

— AHCAH  

Official title:

Advanced Heart Care at Home (AHCAH); a Pragmatic Randomized Trial for Clinicians Nudged to AHCAH, a Heart Failure Specific Home Palliative Care Services

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03724695
• Other study ID #: 831733
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Health Care Utilization
• Heart Failure
• Palliative Care
• Quality Improvement

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, 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

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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

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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

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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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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

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* Note: There are 29 references in all — Click 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