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

N/AActive Not RecruitingNCT07547657

University of Michigan64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Birth; Induced

Interventions

BASEBEHAVIORAL

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

LEADBEHAVIORAL

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

TEAMBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 30 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 30 months

Median time induction to birth

Average time, in hours, between induction start time and time of birth

Time frame: Up to 30 months

Data from ClinicalTrials.gov

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