Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BASE | Behavioral | BASE (low-intensity, training and reporting, delivered virtually) |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michelle Moniz, MD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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.
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.)
Not provided
Not provided
| ID | Term |
|---|---|
| D007854 | Lead |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
Not provided
Not provided
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.
Not provided
Not provided
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.
Not provided
| LEAD | Behavioral | LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually) |
|
| TEAM | Behavioral | TEAM (very high-intensity, clinician-focused, delivered in-person) |
|
| 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 |