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Advanced Heart Care at Home (AHCAH)

Primary Purpose

Palliative Care, Heart Failure, Health Care Utilization

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician nudge or opt out approach for AHCAH liaison visit
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Palliative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Perelman Center for Advanced Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

AHCAH Nudge

Arm Description

Usual Care

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.

Outcomes

Primary Outcome Measures

Acute care days
number of hospitalization days in the University of Pennsylvania Health System

Secondary Outcome Measures

Mortality
number of patient deaths after enrollment in AHCAH
Hospice enrollment
number of patients who transition from AHCAH to hospice
hospice length of service
If transitioned to hospice from AHCAH, number of days on hospice
University of Pennsylvania Health System total acute care cost
cost of emergency department visit and/or hospitalization within the UPHS Health system
Pennsylvania total acute care cost
cost of emergency department visit and/or hospitalization within Pennsylvania
University of Pennsylvania Health System number of intensive care unit days
number of days hospitalized in an intensive care unit within UPHS
Pennsylvania number of intensive care unit days
number of days hospitalized in an intensive care unit within hospitals in Pennsylvania
University of Pennsylvania Health System emergency department visits
number of emergency department visits within UPHS
Pennsylvania emergency department visits
number of emergency department visits within hospitals in Pennsylvania
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
new documentation of goals of care
Advance Care Planning documentation within electronic medical record

Full Information

First Posted
October 28, 2018
Last Updated
October 19, 2022
Sponsor
University of Pennsylvania
Collaborators
Penn Medicine Center for Health Care Innovation, Independence Blue Cross
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1. Study Identification

Unique Protocol Identification Number
NCT03724695
Brief Title
Advanced Heart Care at Home
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
December 13, 2023 (Anticipated)
Study Completion Date
December 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Penn Medicine Center for Health Care Innovation, Independence Blue Cross

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care, Heart Failure, Health Care Utilization, Quality Improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
AHCAH Nudge
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinician nudge or opt out approach for AHCAH liaison visit
Intervention Description
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).
Primary Outcome Measure Information:
Title
Acute care days
Description
number of hospitalization days in the University of Pennsylvania Health System
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Mortality
Description
number of patient deaths after enrollment in AHCAH
Time Frame
6-12 months
Title
Hospice enrollment
Description
number of patients who transition from AHCAH to hospice
Time Frame
6-12 months
Title
hospice length of service
Description
If transitioned to hospice from AHCAH, number of days on hospice
Time Frame
6-12 months
Title
University of Pennsylvania Health System total acute care cost
Description
cost of emergency department visit and/or hospitalization within the UPHS Health system
Time Frame
6-12 months
Title
Pennsylvania total acute care cost
Description
cost of emergency department visit and/or hospitalization within Pennsylvania
Time Frame
6-12 months
Title
University of Pennsylvania Health System number of intensive care unit days
Description
number of days hospitalized in an intensive care unit within UPHS
Time Frame
6-12 months
Title
Pennsylvania number of intensive care unit days
Description
number of days hospitalized in an intensive care unit within hospitals in Pennsylvania
Time Frame
6-12 months
Title
University of Pennsylvania Health System emergency department visits
Description
number of emergency department visits within UPHS
Time Frame
6-12 months
Title
Pennsylvania emergency department visits
Description
number of emergency department visits within hospitals in Pennsylvania
Time Frame
6-12 months
Title
Use of intravenous diuretics at home
Description
Prescription and delivery of intravenous diuretics from Penn Home Infusion Therapy Services and administration of intravenous diuretics by AHCAH nurse
Time Frame
6-12 months
Title
new documentation of goals of care
Description
Advance Care Planning documentation within electronic medical record
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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