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

Study Overview
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Brief Summary
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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.

Official Title
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Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster

Conditions
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Heart Failure

Intervention / Treatment
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* Other: PACT-HF Model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Discharge planning services<br>Proven effective discharge-planning services will be grouped into 'patient-centered care transitions in heart failure' patients. This will be known as the PACT-HF model. | Other: PACT-HF Model<br>* 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<br>|
| No Intervention: Standard Care<br>Standard of care will be provided to HF patients at discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months |  | Within 3 months of hospital discharge | 
| Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days |  | Within 30 days of hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparedness for discharge | Patient-centered outcome, as measured by a validated survey instrument | 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. | 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. | 6 months post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Transitional Care, Knowledge Translation, Outcomes