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

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.

Conflict of interest statement

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.

Figures

Figure 1.. Flow Diagram for the Patient-Centered Care Transitions in HF Pragmatic Stepped-Wedge Cluster Randomized Trial

Ten hospitals crossed over unidirectionally from usual care to the intervention in a randomized sequence. During the intervention phase, patients were excluded if they had Boston score aBased on Boston or biomarker criteria.

Figure 2.. Time to First Composite Readmission, Emergency Department Visit, or Death at 3 Months in the Intervention and Usual Care Groups

Outcomes are measured relative to the date of hospital discharge following index hospitalization for heart failure, with patients analyzed in their allocated treatment group. Median (interquartile range) days of follow-up was 90 (81-90) for the intervention group and 90 (76-90) for the usual care group.

Figure 3.. Time to First Composite Readmission or Emergency Department Visit at 30 Days in the Intervention and Usual Care Groups

Outcomes are measured relative to the date of hospital discharge following index hospitalization for heart failure, with patients analyzed in their allocated treatment group. Median (interquartile range) days of follow-up was 30 (30-30) for the intervention and usual care groups.