Protocol for a Sequential Multiple-Assignment Randomized Trial to Optimize an Adaptive Intervention to Promote Evidence-based Management of Induction of Labor: the IGNITE-IOL Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Provider-level adherence to evidence-based IOL
研究概览
简要总结
This trial is designed to investigate how best to support hospitals in improving induction management and clinical outcomes. The researchers will investigate an adaptive implementation strategy designed to support hospitals in increasing adherence to evidence-based practices for induction of labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the need for investigators to participate in the delivery of the adaptive implementation intervention, neither investigators nor hospitals will be blinded to their assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maternity Clinicians (Individuals implementing QI initiatives on participating maternity units, all bedside clinicians on these units, and any other hospital employees identified by OBI champions as relevant to include, will be eligible to attend LEAD and TEAM activities.)
排除标准
- •Individuals not working on these units are ineligible, which will exclude children under the age of 18 and retired, older adults.
研究组 & 干预措施
BASE + TEAM
BASE + TEAM starts with BASE in Stage 1, continues BASE in Stage 2, continues BASE in Stage 3 for Top Performer hospitals, and adds TEAM in Stage 3 for non-Top Performer hospitals. This arm does not offer LEAD.
干预措施: TEAM (Behavioral)
BASE + LEAD + TEAM
BASE + LEAD + TEAM starts with BASE in Stage 1. In Stage 2, all hospitals are offered LEAD. In Stage 3, Top Performing hospitals continue BASE + LEAD, while non-Top Performing hospitals step up to TEAM in addition to BASE and LEAD. This is considered the most intensive of the four embedded implementation strategies.
干预措施: TEAM (Behavioral)
BASE + TEAM
BASE + TEAM starts with BASE in Stage 1, continues BASE in Stage 2, continues BASE in Stage 3 for Top Performer hospitals, and adds TEAM in Stage 3 for non-Top Performer hospitals. This arm does not offer LEAD.
干预措施: BASE (Behavioral)
BASE + LEAD
BASE + LEAD starts with BASE in Stage 1, adds LEAD in Stage 2 for all hospitals, and continues BASE + LEAD in Stage 3 for all hospitals. This arm does not offer TEAM.
干预措施: LEAD (Behavioral)
BASE only
The BASE only comparator (control arm) starts with BASE in Stage 1, continues with BASE in Stage 2, and continues with BASE in Stage 3, regardless of Top Performer status.
The BASE only arm is defined as the hospitals that get solely BASE (and nothing more) for 30 months.
干预措施: BASE (Behavioral)
BASE + LEAD
BASE + LEAD starts with BASE in Stage 1, adds LEAD in Stage 2 for all hospitals, and continues BASE + LEAD in Stage 3 for all hospitals. This arm does not offer TEAM.
干预措施: BASE (Behavioral)
BASE + LEAD + TEAM
BASE + LEAD + TEAM starts with BASE in Stage 1. In Stage 2, all hospitals are offered LEAD. In Stage 3, Top Performing hospitals continue BASE + LEAD, while non-Top Performing hospitals step up to TEAM in addition to BASE and LEAD. This is considered the most intensive of the four embedded implementation strategies.
干预措施: BASE (Behavioral)
BASE + LEAD + TEAM
BASE + LEAD + TEAM starts with BASE in Stage 1. In Stage 2, all hospitals are offered LEAD. In Stage 3, Top Performing hospitals continue BASE + LEAD, while non-Top Performing hospitals step up to TEAM in addition to BASE and LEAD. This is considered the most intensive of the four embedded implementation strategies.
干预措施: LEAD (Behavioral)
结局指标
主要结局
Provider-level adherence to evidence-based IOL
时间窗: Up to 30 months
Defined as a percentage where the numerator = past month total number of evidence-based IOL techniques offered (regardless of whether they were completed, attempted unsuccessfully, or declined by the patient); and the denominator = past month total number of eligible opportunities to offer any evidence-based IOL technique. Data will be attributed at the individual provider level and analyzed at the provider level for the primary outcome. These data may also be aggregated at the hospital level-e.g., when examining whether % evidence-based IOL adherence at the hospital level is a moderator of the effects of LEAD and TEAM.
次要结局
- Median time from rupture of membranes to birth(Up to 30 Months)
- Adherence to evidence-based induction technique 1 (dual-agent cervical ripening)(Up to 30 months)
- Adherence to technique 2 (early amniotomy)(Up to 30 months)
- Median time induction to birth(Up to 30 months)
- Percent delivery within 24 hours(Up to 30 Months)
- Median time induction to membrane rupture(Up to 30 Months)
研究者
Michelle H. Moniz
Associate Professor, Department of Obstetrics & Gynecology Program Director, The Obstetrics Initiative
University of Michigan