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

NCT05340777 | Completed

• 1 other identifier: 1514537
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Training Obstetric staff on Ellavi UBT DEVICE

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.

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obstetrical care providers who recently participated in a PPH/Ellavi UBT training and/or obstetrical care providers who recently managed a refractory PPH event. The study participant must work in 1 of 3 participating facilities. The number of interviewees per site will vary depending on the size of the facility and number of refractory PPH events. Participants will be selected based on their participation in training sessions, or their management of a PPH event and will include obstetrical staff currently practicing at Tema General Hospital, Kasoa Polyclinic, or Ridge Hospital. Participants may be re-sampled with each use of the UBT.

You may qualify if:

• Labor ward obstetric staff
• Employed at 1 of the 3 hospitals participating in this study.

You may not qualify if:

• Non-obstetric staff
• Obstetric staff not employed at the 3 study hospitals

Sponsors & Collaborators

• PATH: lead
• Ghana Health Services: collaborator

Study Sites (3)

Kasoa Polyclinic

Kasoa, Central Region, Ghana

Location

Ridge Hospital

Accra, Ghana

Location

Tema General Hospital

Accra, Ghana

Location

Related Publications (1)

• Parker ME, Qureshi Z, Deganus S, Soki J, Cofie P, Dapaah P, Owusu R, Gwako G, Osoti A, Ogutu O, Opira J, Sunkwa-Mills G, Boamah M, Srofenyoh E, Aboagye P, Fofie C, Kaliti S, Morozoff C, Secor A, Metzler M, Abu-Haydar E. Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study. BMJ Open. 2023 Feb 3;13(2):e066907. doi: 10.1136/bmjopen-2022-066907.

  PMID: 36737079 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Parker, PhD

  PATH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Officer

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: April 22, 2022
• Study Start: November 18, 2020
• Primary Completion: September 30, 2021
• Study Completion: February 28, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GH (3)