Kenya: An Implementation Study on the Barriers and Facilitators of Scaling up the Innovative, Low-cost Ellavi Uterine Balloon Tamponade for Postpartum Hemorrhage

The purpose of this implementation research study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Kenyan MOH PPH management programs for both public and private sector programs. The investigators aim to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.

Specific objectives:

1. To determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT device into PPH care in three health care facilities (2 public facilities, 1 private facility). The investigators will explore the number of health workers and facilities that receive the PPH and Ellavi UBT training, and percent of health workers and facilities that adopt the Ellavi UBT device over the 6-month period. The investigators will also assess factors that influence the adoption, penetration, sustainability, and fidelity through an operations research survey, and the Ellavi UBT questionnaire.

2. To determine the appropriateness, acceptability and feasibility of using the Ellavi UBT in participating health facilities at various levels of care in Nairobi County, the investigators will explore user comprehension of the Ellavi UBT usage steps, accuracy of use, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.

3. Sensitize senior management at each of the three participating facilities, separately.

4. Conduct two half-day trainings on PPH and Ellavi UBT use at each of the three participating health facilities separated by: 1) obstetricians, medical and clinical officers, and 2) midwives.

5. Collect individual initial (post-training) data to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, and insights into training effectiveness.

6. Case Management Form (CMF): Obstetrical care provider will complete a CMF within 24hrs (<24hrs) of managing each PPH event. This will inform the study team of how decision-making algorithms were applied and accuracy of use.

7. Ellavi UBT Questionnaire: PATH-Kenya study team member will collect individual post (post-usage) Ellavi UBT use data (<72hrs) from each study participant (obstetrical care worker) to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.

8. PATH-Kenya study staff will record secondary data from hospital registry books over the six (6) month duration of this study (March - August 2020) in comparison to the same six (6) month period in 2019 to examine changes in use of condom catheters, and Ellavi UBTs.

9. Use the Consolidated Framework for Implementation Research (CFIR) to identify constructs with the potential to influence the introduction and use of Ellavi UBT. These constructs will be mapped to questions in the questionnaire, and will be analyzed to identify their influence on Ellavi UBT use. Constructs that have influence on the implementation of UBTs (both positively and negatively) will be disseminated for use in future introduction and scale up of Ellavi UBTs.

10. To determine the cost of introducing the Ellavi UBT into the PPH management protocol and health system.

11. Estimate the costs of the different obstetrical care provider training components.

12. Estimate the costs for other country-level activities associated with the introduction of the UBT into the PPH management protocols such as costs for meetings, advocacy, and communication materials.

13. Qualitatively evaluate the frequency and duration of stock outs of condoms, catheters, IV fluids (sterilized materials), and sutures.

14. Estimate the costs of staff time spent on assembling a condom catheter UBT and the costs of supplies used.

15. To disseminate the information in national (KOGS), regional (ECSACOG, AFOG), and international forums to support information sharing, increased awareness of the role of UBT for refractory PPH, and adoption of its use.