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

Heart Failure Clinical Trial

— PACT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112227
• Other study ID #: PACT-HF
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: April 3, 2018
• Start date: March 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: April 2018
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: June 1, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	Population Health Research Institute of McMaster University and Hamilton Health Sciences	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months		Within 3 months of hospital discharge
Primary	Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days		Within 30 days of hospital discharge
Secondary	Preparedness for discharge	Patient-centered outcome, as measured by a validated survey instrument	On admission, at 6 weeks and 6 months post discharge
Secondary	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
Secondary	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