Enhancing Guideline-Directed Medical Therapy at Discharge Through Collaborative Care: Evidence from the TIME-HF Cluster Randomized Controlled Trial.
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Jeemon Panniyammakal, Thottathan Athira, Alex Mariyam, Ismail Sunaib, Mohan Reshmy, Karkuzhiyil Safvan, Charantharalyil Gopalan Bahuleyan, Javaregowda Devaraju Chandgalu, Punnoose Eapen, Rajendiran Gopalan, Unni Govindan, Abdullakutty Jabir, Balakrishnan Jayakumar, J Kandathil Joyal, Joseph Johny, Paul Gnanaraj Justin, Sreedharan Madhu, R Pillai Meera, Nalin Kumar Mahesh, Thomas Paul, Sebastian Placid, Daniel Rachel, Edakutty Rajeev, Ahmad Sajan, Salahuddin Salman, Mattummal Shafeeq, Joseph Stigi, Pisharody Sunil, Syam Natesan, Nair Tiny, Nanjappa Veena, Ganesan Vijayan, George Vijo, Mary Chacko Anu, Ganapathi Sanjay, Harikrishnan Sivadasanpillai
Аннотация
METHODS: The TIME-HF study was a multicenter, open-label, cluster-randomized controlled trial conducted across 22 centers enrolling patients with HFrEF. Centers were randomized 1:1 to an intervention arm (11 centers; 755 patients) or enhanced usual care (11 centers; 752 patients). In the intervention arm, nurses used an mHealth application to review GDMT prescriptions and recommend treatment modifications to physicians. GDMT at discharge was assessed individually and using a composite score. Intervention effects were evaluated using multivariable mixed-effects logistic regression models.
RESULTS: Participants were predominantly male (77.6%) with a mean age of 61.9 years (SD 12.1). Hypertension (56.1%), diabetes (62%), and chronic kidney disease (18.4%) were common comorbidities. Ischemic heart disease was the leading etiology (77.4%), and 48.8% were in NYHA class III/IV. Baseline characteristics were similar between groups. At discharge, 20% received all four GDMT components, with higher use in the intervention group than usual care (27% vs 13%, p < 0.001; adjusted OR 1.61, 95% CI 1.48-1.75). Intervention participants were also more likely to achieve a high GDMT score (OR 1.13, 95% CI 1.04-1.22).
CONCLUSION: An mHealth-supported nurse-led discharge medication review improved GDMT use in HFrEF and may help reduce preventable HF mortality in India. Trial registration: Clinical Trial Registry of India (CTRI/2021/11/037797), Registered on 03/11/2021; the study is ongoing.