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

NCT02112227 | Completed

• 1 other identifier: PACT-HF
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

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

Keywords

Heart Failure; Transitional Care; Knowledge Translation; Outcomes

Outcome Measures

Primary Outcomes (2)

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

  Within 3 months of hospital discharge

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

  Within 30 days of hospital discharge

Secondary Outcomes (3)

• Preparedness for discharge

  On admission, at 6 weeks and 6 months post discharge

• Quality of life, as measured by the EQ5D5L scale

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

• Health Care Costs

  6 months post discharge

Study Arms (2)

Discharge planning services

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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

Interventions

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

Discharge planning services

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In participating hospitals, all patients hospitalized with the most responsible diagnosis of Heart Failure

You may not qualify if:

• Patients who die during hospitalization or are transferred to another hospital

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator
• McMaster University: collaborator

Study Sites (1)

Population Health Research Institute of McMaster University and Hamilton Health Sciences

Hamilton, Ontario, L8L 0A6, Canada

Location

Related Publications (9)

• 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.

  PMID: 39498574 DERIVED

• 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.

  PMID: 38303550 DERIVED

• 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.

  PMID: 34711072 DERIVED

• 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.

  PMID: 34302417 DERIVED

• 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.

  PMID: 33934542 DERIVED

• 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.

  PMID: 33932113 DERIVED

• 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.

  PMID: 33269549 DERIVED

• 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.

  PMID: 30806695 DERIVED

• 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.

  PMID: 29754670 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Harriette Van Spall, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Cardiology, McMaster University

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2015
• Primary Completion: February 29, 2016
• Study Completion: June 1, 2016
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

CA (1)