Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster Randomized Trial

Population Health Research Institute3,500 enrolled

Overview

Heart failure (HF) is the most common cause of hospitalization in older adults. The month after hospital discharge represents a vulnerable period, when patients are at increased risk of death and readmission to hospital. Research has shown that certain discharge-planning services can reduce death and readmissions, but these have not been widely implemented. In this study, we will group evidence-informed discharge-planning services into 'Patient-centered Care Transitions in HF' (PACT-HF), a model of care that will prepare patients for their transition from hospital to home. Through PACT-HF, patients will benefit from a comprehensive assessment of their health care needs, learn to recognize and manage symptoms of HF, and receive the information and follow-up care needed to optimize their health. We will introduce PACT-HF to 10 Ontario hospitals over a number of time periods using a stepped wedge cluster trial design. We will compare the outcomes (hierarchically ordered) of patients in hospitals with PACT-HF to those in hospitals without PACT-HF. We anticipate that patients hospitalized at the sites with PACT-HF will have fewer readmissions, emergency visits, and deaths after discharge; report a better quality of life; and feel more prepared for discharge. We also anticipate that overall, PACT-HF will reduce health system costs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

3,500

Conditions

Heart Failure

Interventions

PACT-HF ModelOTHER

PACT-HF Model includes the following 1) comprehensive patient assessment 2) self-care education 3) patient-centered discharge summary 4) early follow up with FP 5) referral of high-risk patients to regional multidisciplinary HF clinic and to nurse-led home care

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * In participating hospitals, all patients hospitalized with the most responsible diagnosis of Heart Failure Exclusion Criteria: * Patients who die during hospitalization or are transferred to another hospital

Locations (1)

Population Health Research Institute of McMaster University and Hamilton Health Sciences

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months

Time frame: Within 3 months of hospital discharge

Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days

Time frame: Within 30 days of hospital discharge

Secondary Outcomes

Preparedness for discharge

Patient-centered outcome, as measured by a validated survey instrument

Time frame: On admission, at 6 weeks and 6 months post discharge

Quality of life, as measured by the EQ5D5L scale

Health-related quality of life, as measured by the validated EQ5D5L scale. This will be administered on admission and within 6 weeks and 6 months of the patient's discharge.

Time frame: Administered on admission for HF and also 6 weeks and 6 months post discharge

Health Care Costs

Total health care system costs per patient, using the viewpoint of the Ministry of Health. This will be measured using administrative databases.

Time frame: 6 months post discharge

Data from ClinicalTrials.gov

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