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

NCT ID: NCT02112227

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2016-06-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

PACT-HF Model

Intervention Type: 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

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Harriette Van Spall

Assistant Professor of Medicine, Division of Cardiology, McMaster University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harriette Van Spall, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Population Health Research Institute of McMaster University and Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

References

Averbuch T, Lee SF, Zagorski B, Pandey A, Petrie MC, Biering-Sorensen T, Xie F, Van Spall HGC. Long-term clinical outcomes and healthcare resource utilization in male and female patients following hospitalization for heart failure. Eur J Heart Fail. 2025 Feb;27(2):377-387. doi: 10.1002/ejhf.3499. Epub 2024 Nov 5.

Reference Type: DERIVED

PMID: 39498574 (View on PubMed)

Averbuch T, Lee SF, Zagorski B, Mebazaa A, Fonarow GC, Thabane L, Van Spall HGC. Effect of a transitional care model following hospitalization for heart failure: 3-year outcomes of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) randomized controlled trial. Eur J Heart Fail. 2024 Mar;26(3):652-660. doi: 10.1002/ejhf.3134. Epub 2024 Feb 1.

Reference Type: DERIVED

PMID: 38303550 (View on PubMed)

Van Spall HGC, DeFilippis EM, Lee SF, Oz UE, Perez R, Healey JS, Allen LA, Voors AA, Ko DT, Thabane L, Connolly SJ. Sex-Specific Clinical Outcomes of the PACT-HF Randomized Trial. Circ Heart Fail. 2021 Nov;14(11):e008548. doi: 10.1161/CIRCHEARTFAILURE.121.008548. Epub 2021 Oct 29.

Reference Type: DERIVED

PMID: 34711072 (View on PubMed)

Blumer V, Gayowsky A, Xie F, Greene SJ, Graham MM, Ezekowitz JA, Perez R, Ko DT, Thabane L, Zannad F, Van Spall HGC. Effect of patient-centered transitional care services on patient-reported outcomes in heart failure: sex-specific analysis of the PACT-HF randomized controlled trial. Eur J Heart Fail. 2021 Sep;23(9):1488-1498. doi: 10.1002/ejhf.2312. Epub 2021 Aug 16.

Reference Type: DERIVED

PMID: 34302417 (View on PubMed)

Gevaert AB, Tibebu S, Mamas MA, Ravindra NG, Lee SF, Ahmad T, Ko DT, Januzzi JL Jr, Van Spall HGC. Clinical phenogroups are more effective than left ventricular ejection fraction categories in stratifying heart failure outcomes. ESC Heart Fail. 2021 Aug;8(4):2741-2754. doi: 10.1002/ehf2.13344. Epub 2021 May 2.

Reference Type: DERIVED

PMID: 33934542 (View on PubMed)

Averbuch T, Lee SF, Mamas MA, Oz UE, Perez R, Connolly SJ, Ko DT, Van Spall HGC. Derivation and validation of a two-variable index to predict 30-day outcomes following heart failure hospitalization. ESC Heart Fail. 2021 Aug;8(4):2690-2697. doi: 10.1002/ehf2.13324. Epub 2021 May 1.

Reference Type: DERIVED

PMID: 33932113 (View on PubMed)

Van Spall HG, Averbuch T, Lee SF, Oz UE, Mamas MA, Januzzi JL, Ko DT. The LENT index predicts 30 day outcomes following hospitalization for heart failure. ESC Heart Fail. 2021 Feb;8(1):518-526. doi: 10.1002/ehf2.13109. Epub 2020 Dec 2.

Reference Type: DERIVED

PMID: 33269549 (View on PubMed)

Van Spall HGC, Lee SF, Xie F, Oz UE, Perez R, Mitoff PR, Maingi M, Tjandrawidjaja MC, Heffernan M, Zia MI, Porepa L, Panju M, Thabane L, Graham ID, Haynes RB, Haughton D, Simek KD, Ko DT, Connolly SJ. Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. JAMA. 2019 Feb 26;321(8):753-761. doi: 10.1001/jama.2019.0710.

Reference Type: DERIVED

PMID: 30806695 (View on PubMed)

Van Spall HGC, Lee SF, Xie F, Ko DT, Thabane L, Ibrahim Q, Mitoff PR, Heffernan M, Maingi M, Tjandrawidjaja MC, Zia MI, Panju M, Perez R, Simek KD, Porepa L, Graham ID, Haynes RB, Haughton D, Connolly SJ. Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial. Am Heart J. 2018 May;199:75-82. doi: 10.1016/j.ahj.2017.12.013. Epub 2017 Dec 27.

Reference Type: DERIVED

PMID: 29754670 (View on PubMed)

Other Identifiers

PACT-HF

Identifier Type: -

Identifier Source: org_study_id