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

NCT04502173 | Completed

• 1 other identifier: 1512602-2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this implementation research study is to generate evidence that informs the successful uptake and adoption of the Ellavi Uterine Balloon Tamponade (UBT) within Kenyan postpartum hemorrhage (PPH) management programs. The investigators aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan 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 University of Nairobi affiliated hospitals in Nairobi county, Kenya. This study will therefore be exploratory and use a non-experimental design. 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. The investigators will then 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 (2)

• Determine the appropriateness, acceptability and feasibility of using the Ellavi UBT via semi-quantitative surveys (quantitative and qualitative measures) with health care providers in Nairobi County.

  Determine feasibility by measuring: 1) user comprehension of the Ellavi UBT usage steps and accuracy of use by evaluating assembly, timing of use, relevance for patient's health status (semi-quantitative measures), 2) facilitators of use and barriers to use (open ended, qualitative questions on facility placement, leadership influence, procurement channels, patient feedback), and 3) insights into training effectiveness (opened ended qualitative questions on preferred methods of training, quality of teaching provided). These outcome measures will be evaluated using both quantitative (multiple choice, likert scale) and qualitative (open ended explanations) responses. Determine acceptability by measuring: perceptions of the device (likert scale), attitudes towards the device (likert scale), user confidence (likert scale), and usability (likert scale). Determine appropriateness by measuring: patterns of use with open ended qualitative questions.

  6 months

• Determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT by examining hospital record books and collecting quantitative data.

  Determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT device into PPH care at 3 health care facilities using semi-quantitative surveys and hospital level record books. Determine penetration: # facilities participating, # health workers trained, % of all health workers trained at each site. Determine adoption: % of facilities that adopted UBT devices, # of trained health workers who used the UBT. Determine sustainability: proportion of facilities and health worker who use UBTs/month, for 6 months; %l of providers that use the UBT correctly for \>80% of cases. Determine fidelity: % of all health workers surveyed that used the Ellavi UBT.

  6 months

Secondary Outcomes (1)

• Determine the cost of introducing the Ellavi UBT into the PPH management protocol and health system by examining cost data, hospital procurement records, and quantifying labor hours worked.

  6 months

Study Arms (2)

Training

Study participants trained on how to use the Ellavi intra-uterine balloon tamponade via virtual webinar training. Feedback on training course elements will be obtained for future improvements prior to scaling.

Device: Ellavi UBT

Managing PPH

Study participants who provided refractory PPH care using an Ellavi UBT device will give feedback on the barriers and facilitators to use of the newly registered, low-cost medical device.

Device: Ellavi UBT

Interventions

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 gather feedback from the 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)).

Managing PPH; Training

Eligibility Criteria

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

Study Population

Obstetrical care providers who recently participated in a training (before using the Ellavi UBT device for case management) and/or obstetrical care providers who recently managed a refractory PPH event. The study participant must work in one of the three participating health care facilities. The number of interviewees per site will vary depending on the size of the facility and the number of refractory PPH events. Eligible participants will be selected based on their participation in a PPH/Ellavi UBT training session, or their management of a PPH event. The study participants will include obstetricians, midwives, medical officers and clinical officers currently practicing medicine at Kenyatta National Hospital, Mbagathi Hospital, or St. Mary's Mission Hospital. If a facility has only three obstetrical care providers, these people will be re-sampled for each refractory PPH event to understand their interactions with the Ellavi UBT each time.

You may qualify if:

• Obstetricians, medical officers, clinical officers, and midwives who recently participated in a PPH/Ellavi UBT training or managed a refractory PPH case (with or without the use of an Ellavi UBT (within the past 72 hours) at one of the 3 participating health care facilities.
• Hospital administrators, supply store managers and/or procurement staff

You may not qualify if:

• \- Obstetricians, medical officers, clinical officers, and midwives working at the facility who do not agree or consent to participate.

Sponsors & Collaborators

• PATH: lead
• Department for International Development, United Kingdom: collaborator
• University of Nairobi: collaborator

Study Sites (1)

Kenyatta National Hospital

Nairobi, Kenya

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: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: August 6, 2020
• Study Start: December 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)