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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02112227
Acronym
PACT-HF
Enrollment
3500
Registered
2014-04-11
Start date
2015-03-01
Completion date
2016-06-01
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Transitional Care, Knowledge Translation, Outcomes

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.

Interventions

OTHERPACT-HF Model

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

Sponsors

Hamilton Health Sciences Corporation
CollaboratorOTHER
McMaster University
CollaboratorOTHER
Population Health Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 monthsWithin 3 months of hospital discharge
Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 daysWithin 30 days of hospital discharge

Secondary

MeasureTime frameDescription
Preparedness for dischargeOn admission, at 6 weeks and 6 months post dischargePatient-centered outcome, as measured by a validated survey instrument
Quality of life, as measured by the EQ5D5L scaleAdministered on admission for HF and also 6 weeks and 6 months post dischargeHealth-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.
Health Care Costs6 months post dischargeTotal health care system costs per patient, using the viewpoint of the Ministry of Health. This will be measured using administrative databases.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026