Implementation Guided by aN Iterative, adapTivE Strategy - Induction of Labor (IGNITE-IOL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Birth; Induced
• Intervention / Treatment: Behavioral: BASE; Behavioral: TEAM; Behavioral: LEAD

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carey Simpson; Phone Number: 734-936-1644; Email: simpsoca@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Contact: Carey Simpson; Phone Number: 734-936-1644; Email: simpsoca@umich.edu
      • Principal Investigator: Michelle Moniz, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• Individuals not working on these units are ineligible, which will exclude children under the age of 18 and retired, older adults.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: BASE; BASE (low-intensity, training and reporting, delivered virtually)
Experimental: 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.	Behavioral: BASE; BASE (low-intensity, training and reporting, delivered virtually); Behavioral: TEAM; TEAM (very high-intensity, clinician-focused, delivered in-person)
Experimental: 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.	Behavioral: BASE; BASE (low-intensity, training and reporting, delivered virtually); Behavioral: LEAD; LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)
Experimental: 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.	Behavioral: BASE; BASE (low-intensity, training and reporting, delivered virtually); Behavioral: TEAM; TEAM (very high-intensity, clinician-focused, delivered in-person); Behavioral: LEAD; LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider-level adherence to evidence-based IOL	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.	Up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to evidence-based induction technique 1 (dual-agent cervical ripening)	defined as a percentage where the numerator = past month total number of offers of dual-agent cervical ripening (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 dual-agent cervical ripening. Data will be attributed at the individual provider level and analyzed at the provider level for the secondary outcome.	Up to 30 months
Adherence to technique 2 (early amniotomy)	Defined as a percentage where the numerator = past month total number of offers of early amniotomy (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 early amniotomy. Data will be attributed at the individual provider level and analyzed at the provider level for the secondary outcome.	Up to 30 months
Median time induction to birth	Average time, in hours, between induction start time and time of birth	Up to 30 months
Percent delivery within 24 hours	Proportion of patients undergoing induction who deliver within 24 hours of induction start	Up to 30 Months
Median time induction to membrane rupture	Average time, in hours, from induction start to time of rupture of membranes	Up to 30 Months
Median time from rupture of membranes to birth	Average time, in hours, from time of rupture of membranes to time of birth	Up to 30 Months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Michelle Moniz, MD, MSc, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality improvement; adaptive intervention; sequential multiple assignment randomized trial (SMART)
• Additional Relevant MeSH Terms: Inorganic Chemicals; Elements; Metals; Metals, Heavy; Lead
• Other Study ID Numbers: HUM00288513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data generated in this study will be stored and archived in HIPAA-compliant Turbo drives at the University of Michigan. Turbo is a high-capacity, high-performance network storage solution, providing secure and reliable data storage to researchers across the University of Michigan. Due to OBI's existing Data Use Agreements with hospitals, the researchers will not be able to share data in an open repository.
• IPD Sharing Time Frame: The data will be made available to other researchers, as soon as possible after a Data Use Agreement is executed with an interested party and OBI, in accordance with OBI Coordinating Center policy and OBI's existing Data Use Agreements with its member hospitals. To provide access to deidentified data from human subjects, the researchers will verify that the data receiver has met all necessary regulatory requirements (e.g., IRB approval, data use agreements, etc.)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No