- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502173
Kenya: The Barriers and Facilitators of Scaling up the Ellavi UBT for Postpartum Hemorrhage
Kenya: An Implementation Study on the Barriers and Facilitators of Scaling up the Innovative, Low-cost Ellavi Uterine Balloon Tamponade for Postpartum Hemorrhage
Study Overview
Detailed Description
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:
- 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.
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.
- 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-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.
- 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.
- 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 determine the cost of introducing the Ellavi UBT into the PPH management protocol and health system.
- Estimate the costs of the different obstetrical care provider training components.
- 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.
- Qualitatively evaluate the frequency and duration of stock outs of condoms, catheters, IV fluids (sterilized materials), and sutures.
- Estimate the costs of staff time spent on assembling a condom catheter UBT and the costs of supplies used.
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.
e. 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.
f. Host a national level meeting with Kenyan MOH stakeholders and participating facilities g. 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nairobi, Kenya
- Kenyatta National Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Obstetricians, medical officers, clinical officers, and midwives working at the facility who do not agree or consent to participate.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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)).
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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.
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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)).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
Time Frame: 6 months
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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
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Determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT by examining hospital record books and collecting quantitative data.
Time Frame: 6 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 6 months
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Determine the costs of the different training course components by reviewing charges incurred. Determine the costs for country-level activities associated with UBT introduction into the PPH management protocols. This includes costs for meetings, advocacy, and communication materials (e.g. review spreadsheets of costs incurred). Determine the frequency and duration of stock outs of: condoms, catheters, IV fluids (sterilized materials), and sutures by surveying hospital inventory stock. Determine the costs of staff time spent on assembling a condom catheter UBT. Determine the costs of supplied pieces to assemble condoms catheters. |
6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Megan Parker, PhD, PATH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1512602-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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