Adaptation and implementation of a clinical protocol for pre-eclampsia with severe features and eclampsia in a...

Pre-eclampsia is a multisystemic disorder characterized by varied degrees of placental malperfusion. It is estimated to affect 3 - 5% of pregnancies globally, accounting for up to 15% of maternal morbidity and mortality. Solutions to improve outcomes for pre-eclampsia and eclampsia are increasingly focused on improving recognition and on timely, effective treatment, notably through the implementation of treatment guidelines and protocols. To date adoption of guidelines in clinical practice have been variable, with the lowest adoption observed in settings where the policies and evidence did not originate. This study is designed to address known barriers by proposing a stakeholder-led, co-designed protocol adaptation process, followed by an evaluation of the effectiveness of a multi-implementation strategy (education, audit and feedback, and the use of champions) to support practice change.

Using co-design, a protocol for managing pre-eclampsia with severe features and eclampsia will be adapted and implemented. The process will involve three stages; protocol selection and adaptation, implementation of the clinical protocol and evaluation of the process. The primary outcome will be implementation success, assessed across three domains of the Reach, Effectiveness -Adoption Implementation and Maintenance (RE-AIM) framework: Fidelity, Reach, and Adoption. Secondary outcomes, including intervention effectiveness and clinical safety endpoints, will also be evaluated.

The individual components of the RE-AIM framework will be computed as percentages. A composite threshold of 80% will be deemed success. The secondary outcome variables will be compared to the pre-implementation period.