Ghana: The Barriers and Facilitators of Scaling up the Ellavi UBT for Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340777
• Other study ID #: 1514537
• Status: Completed
• Start date: November 18, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this implementation science study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghana's PPH management programs. The investigators aim to improve the likelihood that the Ellavi UBT will be integrated into the health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. The research will be done in three purposively selected facilities near Accra Ghana: Tema General Hospital, Ridge Hospital, and Kasoa Polyclinic.

This study uses a nonexperimental design to collect data on implementation (e.g. # staff trained, usability, user confidence, acceptability, feasibility). The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the 3 participating healthcare facilities on the Ellavi UBT. The investigators will gather feedback from the obstetric healthcare workers (post-training and post-PPH) to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of care (level 4, level 5 (county), level 6 (tertiary)). This process will help to generate training and facility level recommendations for improved uptake and integration into the local maternal care package. Case report forms and semi-quantitative surveys will be completed by obstetrical care providers to evaluate the primary outcomes of acceptability and feasibility by measuring: context of use, accuracy of use, perceptions of the device, user confidence, acceptability, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness. The secondary outcomes will include financial data to determine the cost of introducing the Ellavi UBT into the Kenyan PPH management protocols and the health system. The study will not involve the storage of biological samples. There is not a direct benefit of the study to the individual participants. All study participants will sign consent forms.

Description:

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

Specific objectives:

To determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT device into PPH care in three health care facilities. 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 10-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.

To determine the appropriateness, acceptability and feasibility of using the Ellavi UBT in participating health facilities at various levels of care near Accra, 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.

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

• 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.

• 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.

• 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.

• Ellavi UBT Questionnaire: PATH-Ghana 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.

• PATH-Ghana study staff will record secondary data from hospital registry books over a 9 month duration of this study (January-Sept 2021) in comparison to the same period in 2020 to examine changes in use of condom catheters, and Ellavi UBTs.

• 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.

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

• Summarize how the Ellavi UBT can be integrated into curriculums, guidelines, and hospital systems (e.g. patient-provider friendly materials) by analyzing the key facilitators and barriers.

• Host a national level meeting with Kenyan MOH stakeholders and participating facilities

• Publish and disseminate findings in a peer-reviewed journal h. Present at international conferences and forums, as funding permits. Show the use of Ellavi UBT using poster presentations and demonstration sessions at international obstetrics meetings: FIGO, WHO UBT group, Women Deliver as funding permits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

Inclusion Criteria:

• Labor ward obstetric staff

• Employed at 1 of the 3 hospitals participating in this study.

Exclusion Criteria:

• Non-obstetric staff

• Obstetric staff not employed at the 3 study hospitals

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• Training Obstetric staff on Ellavi UBT
The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the participating healthcare facilities on use of the Ellavi UBT. This will be done to ensure staff are trained on the newly registered and provided medical device. We will gather feedback on how to improve the training curriculum from participants. We will also gather information from the healthcare workers immediately post-use of an Ellavi UBT device following their management of a refractory PPH case. These surveys will help us to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of PPH care.

Locations

Country	Name	City	State
Ghana	Ridge Hospital	Accra
Ghana	Tema General Hospital	Accra
Ghana	Kasoa Polyclinic	Kasoa	Central Region

Sponsors (2)

Lead Sponsor	Collaborator
PATH	Ghana Health Services

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-quantitative post-training survey on the appropriateness and acceptability of using the Ellavi UBT device	Appropriateness will be measured by capturing # deliveries and # postpartum hemorrhage (PPH) cases typically managed per month by the obstetric staff surveyed.; Acceptability will be measured by surveying obstetric staff on their perception of Ellavi UBT effectiveness in comparison to other PPH treatments, attitudes towards the device post training, device usability measures, and user-confidence operating the device.	10 months
Primary	Facility survey (quantitative) to determine adoption, penetration, and sustainability	Adoption will be measured by the # of facilities (of 3 total) who ever used the Ellavi UBT over the 10 month period.; Penetration/Reach will be measured by determining the % of total staff (employed at the 3 hospitals) who were participated in our Ellavi UBT/PPH training courses.; Sustainability is measured by the # facilities (of 3 total) who ever used the Ellavi UBT 4 months after the training (at least 1 time), and the # of facilities that used the Ellavi UBT every month for 6 months after the training.	10 months
Primary	Semi-quantitative post-UBT-use survey on fidelity to training skills, and feasibility of using the Ellavi UBT device	Feasibility will be measured by capturing the # of Ellavi UBT devices used to manage the PPH events, and barriers/enablers to use of the device.; Fidelity will be measured by questions asked on accuracy of use (fidelity to the training)	10 months