Feasibility and Acceptability of Butterfly iQ

Jhpiego1,575 enrolled

Overview

The purpose of this study is to investigate feasibility and acceptability of a novel intervention to integrate Butterfly IQ into antenatal care (ANC) service delivery in Malawi. The study will also explore potential impact of the intervention on selected service delivery outcomes and identification of abnormal pregnancies.

The purpose of this study is to investigate the feasibility and acceptability of a novel intervention to integrate Butterfly IQ into ANC service delivery in Blantyre, Malawi. This study will further the understanding of antenatal ultrasound in Malawi by testing the following hypothesis: When planned and implemented collaboratively with local stakeholders, limited introduction and integration of point-of-care ultrasound with Butterfly iQ into ANC service delivery at health center level will be feasible and acceptable for health providers and clients. The study intervention will include a multi-phased approach to design, introduction, improvement, and evaluation of Butterfly IQ for routine obstetric ultrasound integrated into ANC service delivery in Malawi. Phase 1: Training Phase 1 includes training on Butterfly IQ, integration in ANC workflow, and referral/counter-referral within network. Phase 2: Iterative Service Delivery Phase 2 includes weekly evaluation and iterative re-design of services. Phase 3: Final Evaluation Phase 3 includes evaluation for potential integration into current policies and frameworks; determination to pursue pending additional factors; or determination of incompatibility, as well as selected support for transition/handover, if applicable.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,575

Conditions

Pregnancy Related

Interventions

Butterfly iQDEVICE

The primary intervention under study is the Butterfly iQ point-of-care ultrasound device, embedded in a larger program of training, iterative ANC service delivery design, and a final program evaluation.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Eligibility criteria by phase and participant type Phase 1 Inclusion Criteria 1. Member of HC or hospital staff providing obstetric care. 2. Able and willing to comply with all study requirements and complete all study procedures. 3. Able and willing to provide informed consent to be screened for and to take part in the study. Phase 1 Exclusion Criteria 1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. Phase 2 Inclusion Criteria Study Participant - Health Center and Hospital Staff: 1. Member of HC or hospital staff providing obstetric care. 2. Able and willing to comply with all study requirements and complete all study procedures. 3. Able and willing to provide informed consent to be screened for and to take part in the study. Study Participant - ANC Clients: Participants must meet all criteria to be eligible for inclusion in the study: 1. Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs). 2. At enrollment, present for first ANC visit. 3. Able and willing to comply with all study requirements and complete all Phase 2 study procedures. 4. Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study. 5. Intention to stay within study catchment area for study Phase 2 duration and willingness to give adequate locator information, as defined in site SOPs. Phase 2 Exclusion Criteria Study Participant - Health Center and Hospital Staff: 1\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. Study participant - ANC Clients: 1\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives Phase 3 Inclusion Criteria 1. Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi. 2. Able and willing to comply with all study requirements and complete all Phase 3 study procedures. 3. Able and willing to provide informed consent to be screened for and to take part in Phase 3 of the study. Phase 3 Exclusion Criteria 1\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Locations (1)

Johns Hopkins Research Project

Blantyre, Malawi

Outcomes

Primary Outcomes

Feasibility of the intervention by participant report

Proportion of enrolled midwives who report the intervention to be feasible

Time frame: 7 months

Feasibility of the intervention by quality standards met (ultrasound)

Proportion of ultrasound examinations found to meet quality standards

Time frame: 7 months

Feasibility of the intervention by quality standards met (ANC)

Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards

Time frame: 7 months

Feasibility of the intervention by observation of functioning systems

Proportion of Butterfly IQ systems functioning at end of study period

Time frame: 7 months

Feasibility of the intervention by observation of environments of care

Proportion of participating HC with facilitative environments of care

Time frame: 7 months

Secondary Outcomes

Acceptability, by participant report (providers)

Proportion of providers who find the intervention acceptable

Time frame: 7 months

Acceptability, by participant report (ANC clients)

Proportion of ANC clients who find the intervention acceptable

Time frame: 7 months

Data from ClinicalTrials.gov

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