Implementation Guided by aN Iterative, adapTivE Strategy - Induction of Labor

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07547657
Status
Not Yet Recruiting

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Conditions

  • Birth; Induced

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • BASE — BEHAVIORAL
    BASE (low-intensity, training and reporting, delivered virtually)
  • LEAD — BEHAVIORAL
    LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)
  • TEAM — BEHAVIORAL
    TEAM (very high-intensity, clinician-focused, delivered in-person)

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Provider-level adherence to evidence-based IOL [ Time Frame: Up to 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Carey Simpson
[email protected]
734-936-1644
Michelle Moniz, MD, MSc (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI