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AzTrials

Heart FailurePACT-HFNCT02112227

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

A study testing PACT-HF Model in people with Heart Failure, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Heart Failure
What is being tested?
PACT-HF Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,500 participants
Where
1 siteCanada
Study dates
1 Mar 2015to 1 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Hamilton, Ontario, L8L 0A6

Other trials in Canada

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
PACT-HF Model
Keywords
Heart Failure, Transitional Care, Knowledge Translation, Outcomes
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PACT-HF ModelOther

    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

Study groups in NCT02112227
Study groupRoleWhat they receive
Discharge planning servicesActive comparatorProven 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.
Receives: Other: PACT-HF Model
Standard CareNo interventionStandard of care will be provided to HF patients at discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 3 months of hospital discharge

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

    Measured: Within 30 days of hospital discharge

Secondary outcomes (3)

  1. Preparedness for discharge

    Patient-centered outcome, as measured by a validated survey instrument

    Measured: On admission, at 6 weeks and 6 months post discharge

  2. 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.

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

  3. 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.

    Measured: 6 months post discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study start1 Mar 2015
  3. Primary completion29 Feb 2016
  4. Study completion1 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112227
Sponsor's protocol ID
PACT-HF
Acronym
PACT-HF
Status last verified
Apr 2018
First submitted
9 Apr 2014
Last updated
5 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39498574

  • 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.

    PubMed 38303550

  • 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.

    PubMed 34711072

  • 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.

    PubMed 34302417

  • 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.

    PubMed 33934542

  • 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.

    PubMed 33932113

  • 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.

    PubMed 33269549

  • 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.

    PubMed 30806695

  • 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.

    PubMed 29754670

Questions about this trial

What is this clinical trial studying?

A study testing PACT-HF Model in people with Heart Failure, run by Population Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months (time frame: Within 3 months of hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112227, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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