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

NCT07547657 | Not Yet Recruiting

• 1 other identifier: HUM00288513
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Birth; Induced

Keywords

Quality improvement; adaptive intervention; sequential multiple assignment randomized trial (SMART)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (4)

BASE only

ACTIVE COMPARATOR

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 + TEAM

EXPERIMENTAL

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; Behavioral: TEAM

BASE + LEAD

EXPERIMENTAL

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; Behavioral: LEAD

BASE + LEAD + TEAM

EXPERIMENTAL

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; Behavioral: LEAD; Behavioral: TEAM

Interventions

BASE BEHAVIORAL

BASE (low-intensity, training and reporting, delivered virtually)

BASE + LEAD; BASE + LEAD + TEAM; BASE + TEAM; BASE only

LEAD BEHAVIORAL

LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)

BASE + LEAD; BASE + LEAD + TEAM

TEAM BEHAVIORAL

TEAM (very high-intensity, clinician-focused, delivered in-person)

BASE + LEAD + TEAM; BASE + TEAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Michelle Moniz, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carey Simpson

CONTACT

734-936-1644; simpsoca@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics & Gynecology Program Director, The Obstetrics Initiative

Model Details: This is a clustered, Sequential, Multiple Assignment Randomized Trial (SMART), with up to 64 hospital members of the Obstetrics Initiative (OBI) (see Figure 1). The unit of randomization will be the hospital. Time is measured in months since the onset of Stage 1, when all hospitals are offered BASE. The first randomization-to LEAD vs no LEAD with equal probability-occurs at the beginning of Month 6 (Stage 2). Subsequent randomizations-to TEAM vs no TEAM (Stage 3) with equal probability-occur at the beginning of Month 13, among non-Top Performer hospitals. This SMART will address how best to sequence different strategies across a population, informing the construction of an optimized, three-stage, 30-month adaptive implementation strategy for adherence to evidence-based IOL. This study is a clustered SMART because the sequential randomizations (e.g., to LEAD, to TEAM) are at the hospital level, while the outcome is at the level of providers nested within hospitals.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.)

Locations

US (1)