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Background <p>Evidence-based methods for induction of labor (IOL) are underutilized, increasing risk of prolonged induction, complications, and unnecessary costs. To address heterogeneity in response to quality improvement (QI) efforts, an <i>adaptive implementation strategy</i> can “step up” support to hospitals, moving from less to more intensive support to address inadequate hospital improvement. In a statewide network of hospitals, we developed an adaptive implementation strategy (AIS) with three hospital-level components: <b>(1) BASE</b>, delivered virtually, offers provider training, monthly hospital performance reports, technical assistance, and a participation incentive to hospitals (<i>Intensity: Low</i>); <b>(2) LEAD (unit</b> <b>lead</b><b>ers)</b>, offers recurring virtual calls to support hospital QI leaders (<i>Intensity: Moderate</i>); and (3) <b>TEAM (maternity clinician</b> <b>team</b><b>)</b>, offers two in-person site visits with bedside maternity clinicians (<i>Intensity: Very High</i>). This study aims to build an optimized AIS that guides sequential decisions about which hospitals should receive BASE, LEAD, and TEAM to increase adherence to evidence-based IOL management at scale in a statewide quality collaborative.</p> Methods <p>A clustered, sequential, multiple-assignment randomized trial design with at least 48 hospitals recruited from the Obstetrics Initiative, a perinatal collaborative quality initiative separately funded by Blue Cross Blue Shield of Michigan and Blue Care Network. Evidence-based induction of labor (EB-IOL) includes (a) dual-agent cervical ripening and (b) early amniotomy. Hospitals will receive BASE for five months (Stage 1; Month 1–5). At Month 6, all hospitals are randomized to augment with LEAD vs. continue BASE only (Stage 2; Month 6–12). Hospitals not achieving Top Performer status (defined as ≥ 80% adherence to both dual-agent ripening and early amniotomy) by Month 13 are randomized to augment with TEAM vs. not. Provider-level Outcomes: adherence to EB-IOL (primary); adherence by technique, induction duration metrics (secondary); clinical complications and cost-effectiveness (exploratory).</p> Discussion <p>This trial will answer questions to help construct an optimized AIS that guides implementation support professionals in bolstering hospital efforts to improve induction management and patient outcomes. Knowledge gained may improve the effectiveness and efficiency of future maternity QI initiatives across diverse hospitals and promote widespread, fair patient access to the benefits of QI efforts.</p> Trial registration <p>Record released to ClinicalTrials.gov ID NCT07547657. Awaiting approval and trial registration number.</p>

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Protocol for a sequentially randomized trial to optimize an adaptive implementation strategy to promote evidence-based management of induction of labor: the IGNITE-IOL trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月29日

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  • Michelle H. Moniz,
  • Molly J. Stout,
  • Jourdan E. Triebwasser,
  • Lisa Kane Low,
  • Rebecca Hamm,
  • Carey Simpson,
  • Xilin Chen,
  • Jessi Ems,
  • Amy Kilbourne,
  • David Hutton,
  • Michael Englesbe,
  • Daniel Almirall

摘要

Background

Evidence-based methods for induction of labor (IOL) are underutilized, increasing risk of prolonged induction, complications, and unnecessary costs. To address heterogeneity in response to quality improvement (QI) efforts, an adaptive implementation strategy can “step up” support to hospitals, moving from less to more intensive support to address inadequate hospital improvement. In a statewide network of hospitals, we developed an adaptive implementation strategy (AIS) with three hospital-level components: (1) BASE, delivered virtually, offers provider training, monthly hospital performance reports, technical assistance, and a participation incentive to hospitals (Intensity: Low); (2) LEAD (unit leaders), offers recurring virtual calls to support hospital QI leaders (Intensity: Moderate); and (3) TEAM (maternity clinician team), offers two in-person site visits with bedside maternity clinicians (Intensity: Very High). This study aims to build an optimized AIS that guides sequential decisions about which hospitals should receive BASE, LEAD, and TEAM to increase adherence to evidence-based IOL management at scale in a statewide quality collaborative.

Methods

A clustered, sequential, multiple-assignment randomized trial design with at least 48 hospitals recruited from the Obstetrics Initiative, a perinatal collaborative quality initiative separately funded by Blue Cross Blue Shield of Michigan and Blue Care Network. Evidence-based induction of labor (EB-IOL) includes (a) dual-agent cervical ripening and (b) early amniotomy. Hospitals will receive BASE for five months (Stage 1; Month 1–5). At Month 6, all hospitals are randomized to augment with LEAD vs. continue BASE only (Stage 2; Month 6–12). Hospitals not achieving Top Performer status (defined as ≥ 80% adherence to both dual-agent ripening and early amniotomy) by Month 13 are randomized to augment with TEAM vs. not. Provider-level Outcomes: adherence to EB-IOL (primary); adherence by technique, induction duration metrics (secondary); clinical complications and cost-effectiveness (exploratory).

Discussion

This trial will answer questions to help construct an optimized AIS that guides implementation support professionals in bolstering hospital efforts to improve induction management and patient outcomes. Knowledge gained may improve the effectiveness and efficiency of future maternity QI initiatives across diverse hospitals and promote widespread, fair patient access to the benefits of QI efforts.

Trial registration

Record released to ClinicalTrials.gov ID NCT07547657. Awaiting approval and trial registration number.