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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States. TeamBirth is a rigorously designed care process to improve care and SDM across the full care team, which includes the patient, their support person(s), nurse and physician or midwife, by ensuring reliability for best practices in communication and teamwork during labor and delivery. TeamBirth aims to operationalize best practices in communication and clinical care from the major professional organizations in obstetrics, including the American College of Obstetricians & Gynecologists (ACOG), Society for Maternal-Fetal Medicine (SMFM), American College of Nurse-Midwives (ACNM), and Association of Women's Health, Obstetric, and Neonatal Nurses (AWHONN), to ensure these practices are occurring consistently throughout labor. Key TeamBirth practices include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implemented Health Facility | Other | Health facility that has piloted the "Team Birth Project" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposed study site | Behavioral | The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Clinicians Recommending TeamBirth Project | At the project midline, percent of clinicians (physicians, midwives, and nurses) who would definitely or probably recommend the Team Birth project tools for use in other labor and delivery units. | The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one. |
| Percent of Patients With the Role They Wanted in Decision-Making | At the project midline, percent of patients who definitely or somewhat had the role they wanted in making decisions about their labor, among patients who wanted to make collaborative decisions with clinicians. | The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). Patients were only offered the survey once within the window. |
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Clinician Participant Inclusion Criteria:
Clinician Participant Exclusion Criteria:
Implementation Team Participant Inclusion Criteria:
Implementation Team Participant Exclusion Criteria:
Patient Participant Inclusion Criteria:
Patient Participant Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amber Weiseth, DNP, RN | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Shore Hospital | Weymouth | Massachusetts | 02190 | United States | ||
| Saint Francis Hospital |
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N/A for single group assignment
Clinicians: All nurses, midwives, and obstetricians in the participating units were invited to complete surveys using online links/QR codes; Patients: All patients >= 18 years (except Saint Francis where patients >= 15 years were included) who did not have a fetal demise or scheduled cesarean delivery were eligible during their postpartum stay
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| ID | Title | Description |
|---|---|---|
| FG000 | Implemented Health Facility | Health facility that has piloted the "Team Birth Project" Exposed study site: The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who consented to participate in patient or clinician surveys for the Team Birth Project; individual demographics were not captured for clinicians so all clinician participants are classified as "Unknown or Not Reported"
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| ID | Title | Description |
|---|---|---|
| BG000 | Implemented Health Facility | Health facility that has piloted the "Team Birth Project" Exposed study site: The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Clinicians Recommending TeamBirth Project | At the project midline, percent of clinicians (physicians, midwives, and nurses) who would definitely or probably recommend the Team Birth project tools for use in other labor and delivery units. | Eligible clinicians (physicians, midwives, and nurses) who responded to a survey during the outcome measure time frame | Posted | Count of Participants | Participants | The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one. |
|
Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Maternal Population (Facility Level) | Serious AEs and Other AEs were collected at the facility level for all patients admitted (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data from the General Maternal Population are reported as it could not be ruled out that enrolled maternal participants were not affected by severe maternal morbidity as a Serious AE and/or postpartum hemorrhage and maternal blood transfusion as an Other AE. Severe maternal morbidity was defined as the composite maternal outcomes measure developed by the Centers for Disease Control and Prevention, which includes "unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health". |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Maternal Morbidity | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Assessed only in general maternal population. Data were available from South Shore Hospital, Saint Francis Hospital, and Overlake Medical Center. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Partpartum Hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Assessed only in general maternal population. Data were available from Evergreen Health Medical Center. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amber Weiseth | Ariadne Labs | 206-786-0282 | aweiseth@ariadnelabs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2019 | Apr 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D003142 | Communication |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
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| Tulsa |
| Oklahoma |
| 74136 |
| United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| EvergreenHealth Medical Center | Kirkland | Washington | 98034 | United States |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Percent of Patients With the Role They Wanted in Decision-Making | At the project midline, percent of patients who definitely or somewhat had the role they wanted in making decisions about their labor, among patients who wanted to make collaborative decisions with clinicians. | Eligible patients who responded to a survey and wanted to make collaborative decisions with clinicians during the outcome measure time frame | Posted | Count of Participants | Participants | The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). Patients were only offered the survey once within the window. |
|
|
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| 0 |
| 0 |
| 328 |
| 14,286 |
| 662 |
| 7,716 |
| EG001 | General Neonate Population (Facility Level) | Serious AEs and Other AEs were collected at the facility level for all neonates of admitted patients (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data for the General Neonate Population is reported as it could not be ruled out that neonates of enrolled maternal patient participants were not affected by severe or overall unexpected newborn complications as a Serious AE or Other AE, respectively. Unexpected newborn complications was defined as the composite neonatal outcomes measure developed by the California Maternal Quality Care Collaborative and adopted by The Joint Commission, which includes "unexpected newborn complications among full term newborns with no preexisting conditions". | 0 | 0 | 260 | 11,063 | 50 | 3,737 |
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| Severe Unexpected Newborn Complication Rate | General disorders | Systematic Assessment | Assessed only in general neonate population. Data were available from South Shore Hospital,Saint Francis Hospital, and Evergreen Health Medical Center. |
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| Maternal Blood Transfusion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Assessed only in general maternal population. Data were available from Evergreen Health Medical Center. |
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| Overall Unexpected Newborn Complication Rate | General disorders | Systematic Assessment | Assessed only in general neonate population. Data were available from Overlake Medical Center. |
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| Don't know / no opinion |
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| Prefer not to answer |
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