Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster Randomized Trial (PACT-HF)

April 3, 2018 updated by: Harriette Van Spall, Population Health Research Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 0A6
        • Population Health Research Institute of McMaster University and Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Discharge planning services
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
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
No Intervention: Standard Care
Standard of care will be provided to HF patients at discharge.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On admission, at 6 weeks and 6 months post discharge
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.
Administered on admission for HF and also 6 weeks and 6 months post discharge
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.
6 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

McMaster University
Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

February 29, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACT-HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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