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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PACT-HF Model
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Transitional Care, Knowledge Translation, Outcomes

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Population Health Research Institute of McMaster University and Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Discharge planning services

Standard Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months
Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days

Secondary Outcome Measures

Preparedness for discharge
Patient-centered outcome, as measured by a validated survey instrument
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.
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.

Full Information

First Posted
April 9, 2014
Last Updated
April 3, 2018
Sponsor
Population Health Research Institute
Collaborators
Hamilton Health Sciences Corporation, McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02112227
Brief Title
Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster Randomized Trial
Acronym
PACT-HF
Official Title
Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Population Health Research Institute
Collaborators
Hamilton Health Sciences Corporation, McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Transitional Care, Knowledge Translation, Outcomes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Discharge planning services
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard of care will be provided to HF patients at discharge.
Intervention Type
Other
Intervention Name(s)
PACT-HF Model
Intervention Description
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 Outcome Measure Information:
Title
Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months
Time Frame
Within 3 months of hospital discharge
Title
Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days
Time Frame
Within 30 days of hospital discharge
Secondary Outcome Measure Information:
Title
Preparedness for discharge
Description
Patient-centered outcome, as measured by a validated survey instrument
Time Frame
On admission, at 6 weeks and 6 months post discharge
Title
Quality of life, as measured by the EQ5D5L scale
Description
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.
Time Frame
Administered on admission for HF and also 6 weeks and 6 months post discharge
Title
Health Care Costs
Description
Total health care system costs per patient, using the viewpoint of the Ministry of Health. This will be measured using administrative databases.
Time Frame
6 months post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriette Van Spall, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Population Health Research Institute of McMaster University and Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34711072
Citation
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.
Results Reference
derived
PubMed Identifier
34302417
Citation
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.
Results Reference
derived
PubMed Identifier
33934542
Citation
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.
Results Reference
derived
PubMed Identifier
33932113
Citation
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.
Results Reference
derived
PubMed Identifier
33269549
Citation
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. Erratum In: ESC Heart Fail. 2021 Jun;8(3):2361.
Results Reference
derived
PubMed Identifier
30806695
Citation
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.
Results Reference
derived
PubMed Identifier
29754670
Citation
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.
Results Reference
derived

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

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