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Clinical Trials/NCT02112227
NCT02112227CompletedNot Applicable

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

Population Health Research Institute2 sites in 1 country3,500 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,500
Locations
2
Primary Endpoint
Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Discharge planning services

Active Comparator

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.

Intervention: PACT-HF Model (Other)

Standard Care

No Intervention

Standard of care will be provided to HF patients at discharge.

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

  • Health Care Costs(6 months post discharge)
  • Preparedness for discharge(On admission, at 6 weeks and 6 months post discharge)
  • Quality of life, as measured by the EQ5D5L scale(Administered on admission for HF and also 6 weeks and 6 months post discharge)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harriette Van Spall

Assistant Professor of Medicine, Division of Cardiology, McMaster University

Population Health Research Institute

Study Sites (2)

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