Ghana: The Barriers and Facilitators of Scaling up the Ellavi UBT for Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

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.
    

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 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.
    

Intervention name(s): Training Obstetric staff on Ellavi UBT
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
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.