PHILADELPHIA – A clinical trial of a program that transitions heart failure patients after they’re discharged from the hospital didn’t result in any appreciable improvement in all-cause death, readmissions or emergency department visits after 6 months overall, but it did show that women responded more favorably than men.
Harriette G.C. Van Spall, MD, MPH, reported 6-month results of the Patient-Centered Transitional Care Services in Heart Failure (PACT-HF) trial of 2,494 HF patients at 10 hospitals in Ontario during February 2015 to March 2016. They were randomized to the care-transition program or usual care. The findings, she said at the American Heart Association scientific sessions, “highlight the gap between efficacy that’s often demonstrated in mechanistic clinical trials and effectiveness when we aim to implement these results in real-world settings.” Three-month PACT-HF results were reported previously (JAMA. 2019 Feb 26;321:753-61).
The transitional-care model consisted of a comprehensive needs assessment by a nurse who also provided self-care education, a patient-centered discharge summary, and follow-up with a family physician within 7 days of discharge, which Dr. Van Spall noted “is not current practice in our health care system.”
Patients deemed high risk for readmission or death also received nurse home visits and scheduled visits to a multidisciplinary heart function clinic within 2-4 weeks of discharge and continuing as long as clinically suitable, said Dr. Van Spall, a principal investigator at the Population Health Research Institute, Hamilton, Ont., and assistant professor in cardiology at McMaster University in Hamilton.
The trial found no difference between the intervention and usual-care groups in the two composite endpoints at 6 months, Dr. Van Spall said: all-cause death, readmissions, or ED visits (63.1% and 64.5%, respectively; P = .50); or all-cause readmissions or ED visits (60.8% and 62.4%; P = .36).
“Despite the mutual overall clinical outcomes, we noted specific differences in response to treatment,” she said. With regard to the composite endpoint that included all-cause death, “Men had an attenuated response to the treatment with a hazard ratio of 1.05 (95% confidence interval, 0.87-1.26), whereas women had a hazard ratio of 0.85 (95% CI, 0.71-1.03), demonstrating that women have more of a treatment response to this health care service,” she said.
In men, rates for the first primary composite outcome were 66.3% and 64.1% in the intervention and usual-care groups, whereas in women those rates were 59.9% and 64.8% (P = .04 for sex interaction).
In the second composite endpoint, all-cause readmission or ED visit, “again, men had an attenuated response” with a HR of 1.03, whereas women had a HR of 0.83. Results were similar to those for the first primary composite outcome: 63.4% and 61.7% for intervention and usual care in men and 57.7% and 63% in women (P = .03 for sex interaction).
In putting the findings into context, Dr. Van Spall said tailoring services to risk in HF patients may be fraught with pitfalls. “We delivered intensive services to those patients at high risk of readmission or death, but it is quite possible they are the least likely to derive benefit by virtue of their advanced heart failure,” she said. “It may be that more benefit would have been derived had we chosen low- or moderate-risk patients to receive the intervention.”
She also said the sex-specific outcomes must be interpreted with caution. “But they do give us pause to consider that services could be titrated more effectively if delivered to patients who are more likely to derive benefit,” Dr. Van Spall said. The finding that women derived more of a benefit is in line with other prospective and observational studies that have found that women have a higher sense of self-care, self-efficacy, and confidence in managing their own health care needs than men.
Dr. Van Spall has no financial relationships to disclose.