Birth; Induced
Conditions
Keywords
Quality improvement, adaptive intervention, sequential multiple assignment randomized trial (SMART)
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.
Interventions
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider-level adherence to evidence-based IOL | Up to 30 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to evidence-based induction technique 1 (dual-agent cervical ripening) | Up to 30 months | 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. |
| Adherence to technique 2 (early amniotomy) | Up to 30 months | 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. |
| Median time induction to birth | Up to 30 months | Average time, in hours, between induction start time and time of birth |
| Percent delivery within 24 hours | Up to 30 Months | Proportion of patients undergoing induction who deliver within 24 hours of induction start |
| Median time induction to membrane rupture | Up to 30 Months | Average time, in hours, from induction start to time of rupture of membranes |
| Median time from rupture of membranes to birth | Up to 30 Months | Average time, in hours, from time of rupture of membranes to time of birth |
Countries
United States
Contacts
CONTACTCarey Simpson
PRINCIPAL_INVESTIGATORMichelle Moniz, MD, MSc
University of Michigan
Outcome results
None listed