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Completed

NCT Number: NCT02112227

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Population Health Research Institute of McMaster University and Hamilton Health Sciences

Hamilton, Ontario, L8L 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACT-HF Model

Other

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

Primary outcomes

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

    Time frame: Within 3 months of hospital discharge

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

    Time frame: Within 30 days of hospital discharge

Secondary outcomes

  1. Preparedness for discharge

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

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

  2. Quality of life, as measured by the EQ5D5L scale

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

    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.

  3. Health Care Costs

    Time frame: 6 months post discharge

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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • McMaster University

Registry information

Official study title

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

Acronym: PACT-HF

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2014
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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