Palliative CareAHCAHNCT03724695
Advanced Heart Care at Home
A study testing Clinician nudge or opt out approach for AHCAH liaison visit in people with Palliative Care and Heart Failure, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Heart Failure, Health Care Utilization
- What is being tested?
- Clinician nudge or opt out approach for AHCAH liaison visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 709 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2018to 29 Oct 2024
- Phase
- Interventional
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
Who may be able to join
- At least 18 years of age
- Reside within Caring Way's geographic catchment
- Heart Failure ICD code from any previous healthcare encounter (inpatient or outpatient) in the 12 months prior to index hospitalization
- Admitted to a cardiology or hospitalist service
- Palliative Connect score greater than 0.3
- Index hospitalization during study period
Who cannot join
- Less than 18 years of age
- Pregnant women
- Incarcerated patients
- Homeless patients
- Reside outside of Caring Way's geographic catchment
- Patients without an identifiable primary physician for AHCAH staff to communicate with as determined by the AHCAH liaison via EPIC
- Prior hospitalization during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 191014
About this study
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
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.
- Being tested
- Clinician nudge or opt out approach for AHCAH liaison visit
- Medical subject headings
- Heart Failure, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician nudge or opt out approach for AHCAH liaison visitOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| AHCAH Nudge | Experimental | The investigators have developed methods for sending "nudges" to clinicians via secure text messages to primary teams to alert them that their patient was identified as high-risk for 6-month mortality and that an AHCAH liaison would visit their patient to discuss the AHCAH program and to facilitate enrollment if the patient was amenable. The investigators propose that these secure text messages would be sent to the teams of patients randomized to the intervention by the AHCAH liaison within 72 hours of eligibility identification (to allow for the liaison not being available over the weekend). The investigator team will track all aspects of messaging and timing. Clinicians can choose to opt out a patient from the liaison visit and AHCAH enrollment within a two-hour timeframe. Receives: Other: Clinician nudge or opt out approach for AHCAH liaison visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute care days
number of hospitalization days in the University of Pennsylvania Health System
Measured: 6-12 months
Secondary outcomes (11)
Mortality
number of patient deaths after enrollment in AHCAH
Measured: 6-12 months
Hospice enrollment
number of patients who transition from AHCAH to hospice
Measured: 6-12 months
hospice length of service
If transitioned to hospice from AHCAH, number of days on hospice
Measured: 6-12 months
University of Pennsylvania Health System total acute care cost
cost of emergency department visit and/or hospitalization within the UPHS Health system
Measured: 6-12 months
Pennsylvania total acute care cost
cost of emergency department visit and/or hospitalization within Pennsylvania
Measured: 6-12 months
University of Pennsylvania Health System number of intensive care unit days
number of days hospitalized in an intensive care unit within UPHS
Measured: 6-12 months
Pennsylvania number of intensive care unit days
number of days hospitalized in an intensive care unit within hospitals in Pennsylvania
Measured: 6-12 months
University of Pennsylvania Health System emergency department visits
number of emergency department visits within UPHS
Measured: 6-12 months
Pennsylvania emergency department visits
number of emergency department visits within hospitals in Pennsylvania
Measured: 6-12 months
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
Measured: 6-12 months
new documentation of goals of care
Advance Care Planning documentation within electronic medical record
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start13 Nov 2018
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Penn Medicine Center for Health Care Innovation, Independence Blue Cross
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724695
- Sponsor's protocol ID
- 831733
- Acronym
- AHCAH
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2018
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18926436Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.
PubMed 18672162Sahlen 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.
PubMed 26603186Murray SA, Boyd K, Kendall M, Worth A, Benton TF, Clausen H. Dying of lung cancer or cardiac failure: prospective qualitative interview study of patients and their carers in the community. BMJ. 2002 Oct 26;325(7370):929. doi: 10.1136/bmj.325.7370.929.
PubMed 12399341Warraich 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.
PubMed 30167645Rogers 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.
PubMed 28705314Temel 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.
PubMed 20818875Goodlin SJ, Kutner JS, Connor SR, Ryndes T, Houser J, Hauptman PJ. Hospice care for heart failure patients. J Pain Symptom Manage. 2005 May;29(5):525-8. doi: 10.1016/j.jpainsymman.2005.03.005. No abstract available.
PubMed 15904755Halpern 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.
PubMed 21817878Halpern 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.
PubMed 12057879Halpern 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.
PubMed 12654404Halpern 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.
PubMed 12117401Halpern SD. Evidence-based equipoise and research responsiveness. Am J Bioeth. 2006 Jul-Aug;6(4):1-4. doi: 10.1080/15265160600843528. No abstract available.
PubMed 16885091Halpern 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.
PubMed 19602971Kitamura 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.
PubMed 6265677