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Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart FailureThe PACT-HF Randomized Clinical Trial

Educational Objective
To understand that interventions found to be efficacious under restricted conditions may not improve clinical outcomes when implemented at the level of the health care system.
1 Credit CME
Key Points

Question  Can implementing a group of evidence-informed transitional care services in a publicly funded health care system improve outcomes among patients discharged after hospitalization for heart failure?

Findings  In this pragmatic stepped-wedge cluster randomized trial that included 2494 patients in 10 hospitals in Ontario, Canada, there were no significant differences between patients who were randomized to receive a care transition program vs usual care in the primary composite outcome of time to all-cause readmission, emergency department visit, or death at 3 months (hazard ratio, 0.99) or the co–primary composite outcome of all-cause readmission or emergency department visit at 30 days (hazard ratio, 0.92).

Meaning  This patient-centered transitional care service model did not improve a composite of clinical outcomes in patients hospitalized for heart failure.

Abstract

Importance  Health care services that support the hospital-to-home transition can improve outcomes in patients with heart failure (HF).

Objective  To test the effectiveness of the Patient-Centered Care Transitions in HF transitional care model in patients hospitalized for HF.

Design, Setting, and Participants  Stepped-wedge cluster randomized trial of 2494 adults hospitalized for HF across 10 hospitals in Ontario, Canada, from February 2015 to March 2016, with follow-up until November 2016.

Interventions  Hospitals were randomized to receive the intervention (n = 1104 patients), in which nurse-led self-care education, a structured hospital discharge summary, a family physician follow-up appointment less than 1 week after discharge, and, for high-risk patients, structured nurse homevisits and heart function clinic care were provided to patients, or usual care (n = 1390 patients), in which transitional care was left to the discretion of clinicians.

Main Outcomes and Measures  Primary outcomes were hierarchically ordered as composite all-cause readmission, emergency department (ED) visit, or death at 3 months; and composite all-cause readmission or ED visit at 30 days. Secondary outcomes were B-PREPARED score for discharge preparedness (range: 0 [most prepared] to 22 [least prepared]); the 3-Item Care Transitions Measure (CTM-3) for quality of transition (range: 0 [worst transition] to 100 [best transition]); the 5-level EQ-5D version (EQ-5D-5L) for quality of life (range: 0 [dead] to 1 [full health]); and quality-adjusted life-years (QALY; range: 0 [dead] to 0.5 [full health at 6 months]).

Results  Among eligible patients, all 2494 (mean age, 77.7 years; 1258 [50.4%] women) completed the trial. There was no significant difference between the intervention and usual care groups in the first primary composite outcome (545 [49.4%] vs 698 [50.2%] events, respectively; hazard ratio [HR], 0.99 [95% CI, 0.83-1.19]) or in the second primary composite outcome (304 [27.5%] vs 408 [29.3%] events, respectively; HR, 0.93 [95% CI, 0.73-1.18]). There were significant differences between the intervention and usual care groups in the secondary outcomes of mean B-PREPARED score at 6 weeks (16.6 vs 13.9; difference, 2.65 [95% CI, 1.37-3.92]; P < .001); mean CTM-3 score at 6 weeks (76.5 vs 70.3; difference, 6.16 [95% CI, 0.90-11.43]; P = .02); and mean EQ-5D-5L score at 6 weeks (0.7 vs 0.7; difference, 0.06 [95% CI, 0.01 to 0.11]; P = .02) and 6 months (0.7 vs 0.6; difference, 0.06 [95% CI, 0.01-0.12]; P = .02). There was no significant difference in mean QALY between groups at 6 months (0.3 vs 0.3; difference, 0.00 [95% CI, −0.02 to 0.02]; P = .98).

Conclusions and Relevance  Among patients with HF in Ontario, Canada, implementation of a patient-centered transitional care model compared with usual care did not improve a composite of clinical outcomes. Whether this type of intervention could be effective in other health care systems or locations would require further research.

Trial Registration  ClinicalTrials.gov Identifier: NCT02112227

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Article Information

Corresponding Author: Harriette G. C. Van Spall, MD, MPH, Population Health Research Institute, 20 Copeland Ave, David Braley Research Institute Bldg, Ste C3-117, Hamilton, ON L8L 0A3, Canada (harriette.vanspall@phri.ca).

Accepted for Publication: January 23, 2019.

Author Contributions: Dr Erbas Oz and Mr Perez had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Van Spall, Lee, Xie, Haughton, Connolly.

Acquisition, analysis, or interpretation of data: Van Spall, Lee, Xie, Erbas Oz, Perez, Mitoff, Maingi, Tjandrawidjaja, Heffernan, Zia, Porepa, Panju, Thabane, Haynes, Simek, Ko, Connolly.

Drafting of the manuscript: Van Spall, Lee.

Critical revision of the manuscript for important intellectual content: Van Spall, Lee, Xie, Mitoff, Maingi, Heffernan, Zia, Porepa, Panju, Thabane, Graham, Haynes, Simek, Ko.

Statistical analysis: Van Spall, Lee, Xie, Erbas Oz, Perez, Thabane, Connolly.

Obtained funding: Van Spall, Graham, Haynes, Connolly.

Administrative, technical, or material support: Van Spall, Perez, Mitoff, Maingi, Tjandrawidjaja, Heffernan, Zia, Porepa, Simek, Ko.

Supervision: Van Spall, Haughton, Connolly.

Conflict of Interest Disclosures: Dr Van Spall reports speaker fees from Roche Diagnostics and is supported by MOHLTC and the Hamilton Health Sciences Early Career Award. Dr Ko reports support from an Ontario Mid-Career Scientist Award from the Heart and Stroke Foundation of Canada, Ontario’s office. Dr Connolly reports receiving grants and personal fees from Bayer, Bristol Myers-Squibb Pfizer, Portola, Bristol Myers-Squibb, Daiichi Sankyo, and Medtronic. No other disclosures were reported.

Funding/Support: This study was funded by peer-reviewed grants held by Dr Van Spall from the Canadian Institutes of Health Research (135917) and Ontario Ministry of Health and Long Term Care (MOHLTC) Health System Research Fund (6686), as well as in-kind support from the participating hospitals and Community Care Access Centers and from Roche Diagnostics.

Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication or veto the publication.

Disclaimer: The study was coordinated by PHRI of Hamilton Health Sciences Corporation and McMaster University. Statistical analysis was conducted at ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Parts of this material are based on data and information compiled and provided by the Canadian Institute for Health Information (CIHI). The opinions, results, and conclusions reported in this article, and selection of journal for submission, are those of the authors and are independent from the funding sources. The analyses, results, conclusions, opinions, and statements expressed in this article are those of the authors, and are independent from the funding sources, ICES, or CIHI. No endorsement by funding sources, ICES, CIHI, or the Ontario MOHLTC is intended or should be inferred.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We are indebted to Daniel Ball, MA (Halton Healthcare), Elizabeth Banting, RN (Southlake Regional Health Centre), Maria De Leon, RN (Mississauga Halton CCAC), Nancy Elford, MN (Michael Garron Hospital), Jeanine Harrison, MN (Southlake Regional Health Centre), Elena Holt, MHSc (St Joseph’s Health Centre), Quazi Ibrahim, MSc (Population Health Research Institute [PHRI]), Gail Johnson, MSc (Guelph General Hospital), Colleen Lackey, RN (Ontario Telemedicine Network), Bill Liu, MSc (PHRI), Roberta Napoleoni, DipBA (PHRI), Tracy Renton, BNc (Trillium Health Partners), Donna Richardson, BScN (Trillium Health Partners), Teresa Smith, MBA (Hamilton Health Sciences), Nazneen Solkar, BPhm, (PHRI) Anne Stephens, MEd (Toronto Central LHIN), and Shannon Tyrrell, MHM (Trillium Health Partners) for their roles in the trial. PHRI employees received salary support for their roles through the study’s grant funds. The roles of employees from other institutions were funded by in-kind institutional support. This work is dedicated to the memory of Aubrey Ignatius Van Spall.

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