Sepsis
Conditions
Interventions
Enhanced Discharge Intervention
Enhanced Discharge Intervention plus the Interactive Voice Response system
Sponsors
Infectious Diseases Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At admission 1. Adults =18 years. 2. Participant’s hospital admission diagnosis is consistent with the following broad definition of sepsis, incorporating its principal components: a. Signs of infection: Suspected or proven infection, as determined by the medical team in charge. b. 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. 3. 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. 4. Participants has a functional SIM card registered either in their own name or in the name of a proxy or willing and able to register one during their admission period. 5. 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 6. 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. 7. Participant is willing and able to comply with scheduled phone follow-ups, and other study procedures. 8. 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. 9. The participant confirms that there is availability of mobile network coverage in their place of residence.
Exclusion criteria
Exclusion criteria: At admission 1. Patient who requires hospitalization for a condition that requires emergent or urgent obstetric or surgical intervention 2. Persons who are currently or have been previously enrolled into this study. 3. Patient is terminally ill due to an underlying condition other than sepsis. 4. The patient is a detainee or prisoner. 5. The patient is unable to speak English and Country Local language. At discharge 6. The patient is unable to confirm SIM card registration in their name or in the name of the proxy. 7. The patient is unable to hear. 8. Participant states they will be unable to return to same health facility for the scheduled 14-day post-discharge clinic assessment 9. Patients requiring clinical care for more than 10 days (if clinical care was completed and participant is ready for discharge but are still in hospital for financial or logistical reasons beyond 10 days, they can still be eligible).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy on 90-day post-discharge mortality among adult participants hospitalized with sepsis randomized to receive one of two post discharge follow-up strategies – EDI versus EDI plus IVR tool | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy on 28-day mortality among participants hospitalized with sepsis randomized to receive one of two post discharge follow-up strategies – EDI versus EDI plus IVR tool;To evaluate proportion of participants within the two study arms who return for scheduled post discharge follow-up visits;To evaluate the proportion of participants within the two study arms who require re-admission to hospital during the post-discharge period of 90 days;To evaluate participant quality of life at 28- and 90-days post discharge period within two study arms.;To compare baseline demographic and clinical characteristics between participants who were randomized and those who did not meet randomization criteria (screen failures) | — |
Countries
Ghana, Nigeria, Uganda
Contacts
Public ContactMax Okwero
Trial Coordinator
Outcome results
None listed