Evaluating The Impact on 90-day Survival Of Post-Discharge Follow-up Strategies Delivered To Adult Patients Hospitalized With Sepsis Across A Research Network In Sub-Saharan Africa
Objectives: The study aims to evaluate two post-discharge follow-up strategies for adult patients hospitalized with sepsis, focusing on their efficacy in reducing the 90-day mortality, and their effect on return to follow-up, number of re-admissions, and quality of life. Primary efficacy endpoint * 90- day all-cause mortality post discharge Secondary end points * Time to death * 28-day all-cause mortality * Attendance within 14-day check-up post discharge * Re-admission within 28 and 90 days * Days alive and out of hospital (DAOH) * Quality of life score (Baseline vs 28 day and Baseline vs 90 days) * Differences in baseline demographic and clinical characteristics (e.g., age, sex, disease severity, comorbidities, key laboratory values) between randomized participants and screen failures. Study design: This is an open-label, randomized, parallel, interventional study, with two post-discharge follow-up strategies: 1) EDI; or 2) EDI plus IVR system. Fixed allocation randomization at a 1:1 ratio will be applied to either study arm. Sample size: A total of 1,410 (705 per arm) from the four countries (Uganda, Nigeria, Ghana and Mozambique) will be enrolled competitively across the sites.
• At admission
‣ Adults ≥18 years.
⁃ Participant's hospital admission diagnosis is consistent with the following broad definition of sepsis, incorporating its principal components (signs of infection plus signs of severity/organ dysfunction):
• Signs of infection: Suspected or proven infection, as determined by the medical team in charge.
∙ Illness severity: Decision of the medical team to admit the patient to an adult medical ward of the study hospital, according to clinical appraisal of the treating physician and applicable guidelines.
⁃ Participant/proxy is willing to have their medical records reviewed by the trial team and get daily follow-ups until the time of discharge and to be approached again by the study team for a second informed consent process towards the time of hospital discharge.
⁃ Evidence of a personally signed and dated informed consent form stating that the participant/proxy has been informed of, had opportunity to ask questions about and have consented to the initial study procedures that will be conducted during their hospitalization. At discharge
⁃ Patient has overcome the critically ill phase of their hospitalization and is, according to the non-study clinical team caring for the patient, expected to be discharged within the next 24 hours.
⁃ Participant is willing and able to comply with scheduled phone follow-ups, and other study procedures.
⁃ Evidence of a personally signed and dated informed consent form stating that the participant has been informed of, had opportunity to ask questions about and have consented to all procedures that will be conducted at the time of and after their discharge, and alternatives and risks for the study.
⁃ The participant confirms that there is availability of mobile network coverage in their place of residence.