Collaboration for Antepartum Risk Evaluation
- Conditions
- Perinatal CareMidwiferyMaternal Health ServicesMaternal-child Health ServicesPrenatal Care
- Interventions
- Behavioral: Comparison Care- Usual Care + primary midwifeBehavioral: Collaborative Care
- Registration Number
- NCT02786225
- Lead Sponsor
- Vanderbilt University
- Brief Summary
Perinatal outcomes in the US rank behind most other developed countries even though women in the US utilize more maternity services. Current approaches to consultation and collaboration among perinatal care providers, including nurse-midwives, obstetricians, and perinatologists, fragment care resulting in communication errors and maternal dissatisfaction. The CARE study will test an innovative interdisciplinary consult visit to improve communication, teamwork, maternal satisfaction, and perinatal outcomes.
- Detailed Description
Perinatal outcomes in the United States rank below many other developed countries. National organizations, such as the American College of Obstetricians and Gynecologists, have called for women to utilize the level and provider of maternity services that meet their personal and medical needs. This leveled approach to care requires consultation and collaboration among providers to ensure women receive appropriate services. While national and international organizations have called for team-based maternity care, current models can fragment services, increasing the risk of communication errors. Women can feel disenfranchised by models that do not meet their needs and opt out of beneficial services altogether.
Currently, there is not evidence on effective interdisciplinary models of maternity care. The Collaboration for Antepartum Risk Evaluation (CARE) study will use a randomized design to systematically test the effect of interdisciplinary consults on women and providers. The two aims of the study are: (1) evaluate the effect of collaborative vs individual consults on participant outcomes including communication quality (using the Communication Assessment Tool, team version), maternal satisfaction (using a modified Satisfaction with Prenatal Care measure), semi-structured interviews, adherence to the developed plan of care, and perinatal outcomes; (2) evaluate the effect of the CARE clinic on providers using the Communication Assessment Tool- team version, the Agency for Healthcare Research and Quality (AHRQ) Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) questionnaire, and semi-structured interviews.
The CARE study will provide valuable information on effective models for patient-centered maternity care. The AHRQ K08 will allow Dr. Philippi to implement the CARE study and facilitate her growth into a national leader in midwifery and health services research.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 182
- Adult pregnant women receiving prenatal care at the VUSN Nurse-Midwifery Faculty Practice.
- Gestational age of pregnancy 4-40 weeks
- Needs a consultation with perinatologist for one of the following reasons:
Prior pregnancy with congenital abnormality History of fetal demise >20 weeks History of preterm labor in previous pregnancy Current maternal drug or alcohol abuse Controlled maternal condition (e.g. thyroid disorder) Mild abnormality of fetus or placenta on ultrasound Idiopathic thrombocytopenia in pregnancy
- Can attend the collaborative care clinic
- Unable to give consent for research participation - including age < 18 or impaired mental function
- Urgent medical condition requiring immediate assessment including: ectopic pregnancy or vaginal bleeding
- Medical conditions outside of scope of VUSN midwifery guidelines including:
Chronic maternal conditions requiring specialist involvement including: HIV, epilepsy, uncontrolled asthma, and liver, renal, cardiac disease.
Multiple gestation > 2 previous cesarean births Rh isoimmunization Incompetent cervix Major fetal or placenta abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparison Care- Usual Care + primary midwife Comparison Care- Usual Care + primary midwife Comparison Group: Usual care enhanced with primary midwife. Women in the comparison group (n=118) will receive the standard individual consult visit with a perinatologist and then, if they return to midwifery care, have one consistent midwife (primary midwife) for the majority of remaining prenatal care. Collaborative Care Collaborative Care Intervention Group: Women (n=118) will be seen one time, simultaneously by a Vanderbilt University Medical Center (VUMC) perinatologist and a Vanderbilt University School of Nursing (VUSN) nurse-midwife (the CARE visit). During the CARE visit, the nurse-midwife and perinatologist will complete the CARE checklist The checklist will be signed by the woman and providers and scanned into the medical record. Following the CARE visit, women will return to midwifery care or be referred to perinatology depending on their needs, remaining in the study. Women returning to the midwifery practice will see a primary midwife for the remainder of care.
- Primary Outcome Measures
Name Time Method Communication Assessment Tool (CAT)-Team survey 2 weeks after intervention/comparison visit The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
Satisfaction with Prenatal Care (SPC) scale 2 weeks after intervention/comparison visit The SPC scale assesses patient satisfaction with prenatal care
Communication Assessment Tool (CAT)-Team survey - following birth Within 2 weeks after patient gives birth The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
Satisfaction with Prenatal Care (SPC) scale - following birth Within 2 weeks after patient gives birth The SPC scale assesses patient satisfaction with prenatal care
- Secondary Outcome Measures
Name Time Method Location of birth 1 week after patient gives birth Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route
Trial of labor after cesarean 1 week after the mother gives birth Whether the woman was attempting a trial of labor after a previous cesarean birth
Breastfeeding at birth 1 week after patient gives birth Breastmilk feeding of the infant at the time of birth
Provider at admission to labor and delivery 1 week after patient gives birth Medical care provider at the time of admission in labor
Gestational age at birth 1 week after patient gives birth the gestational age of the baby at the time of birth - in weeks+days
Infant birth weight 1 week after patient gives birth Infant birth weight in grams as collected within 4 hours of birth
Smoking at 1st prenatal visit 1 week after the patient gives birth For smokers, number of cigarettes per day 1 week after the patient gives birth Number of cigarettes per day
Mode of birth 1 week after patient gives birth Number of women giving birth via 1 of 4 methods: vaginal/assisted vaginal/cesarean after labor/planned cesarean
Generalized Anxiety Disorder 7-item scale (GAD-7) Within 2 weeks after patient gives birth Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Patient & provider adherence to checklist plan 1 week after patient gives birth Congruence between the anticipated plan of care at the time of the intervention/comparison visit and what occurred at the time of birth
Breastfeeding at discharge 1 week after patient gives birth Breastmilk feeding of the infant at the time of discharge.
Hospital stay postpartum 1 week after patient gives birth Lengths of postpartum hospital stay in calendar days
Vaginal birth after cesarean 1 week after patient gives birth Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.
Complications at birth 1 week after patient gives birth The presence of any adverse outcomes during pregnancy, birth, postpartum, including details
Trial Locations
- Locations (1)
Vanderbilt School of Nursing
🇺🇸Nashville, Tennessee, United States