Vanderbilt School of Nursing
Nashville, Tennessee, 37240, United States
NCT Number: NCT02786225
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Nashville, Tennessee, 37240, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
Intervention Group: Women (n=118) will be seen one time, simultaneously by a VUMC perinatologist and a 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.
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.
Time frame: 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.
Time frame: 2 weeks after intervention/comparison visit
The SPC scale assesses patient satisfaction with prenatal care
Time frame: 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.
Time frame: Within 2 weeks after patient gives birth
The SPC scale assesses patient satisfaction with prenatal care
Time frame: 1 week after the patient gives birth
Time frame: 1 week after the patient gives birth
Number of cigarettes per day
Time frame: 1 week after patient gives birth
Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route
Time frame: 1 week after patient gives birth
Medical care provider at the time of admission in labor
Time frame: 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
Time frame: 1 week after patient gives birth
the gestational age of the baby at the time of birth - in weeks+days
Time frame: 1 week after patient gives birth
Infant birth weight in grams as collected within 4 hours of birth
Time frame: 1 week after patient gives birth
Number of women giving birth via 1 of 4 methods: vaginal/assisted vaginal/cesarean after labor/planned cesarean
Time frame: 1 week after the mother gives birth
Whether the woman was attempting a trial of labor after a previous cesarean birth
Time frame: 1 week after patient gives birth
Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.
Time frame: 1 week after patient gives birth
The presence of any adverse outcomes during pregnancy, birth, postpartum, including details
Time frame: 1 week after patient gives birth
Breastmilk feeding of the infant at the time of birth
Time frame: 1 week after patient gives birth
Breastmilk feeding of the infant at the time of discharge.
Time frame: 1 week after patient gives birth
Lengths of postpartum hospital stay in calendar days
Time frame: 2 weeks after intervention/comparison visit
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Time frame: Within 2 weeks after patient gives birth
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Vanderbilt University
Other
Interprofessional Perinatal Consults to Improve Communication Quality, Satisfaction, and Team Cohesion: A Randomized Trial of the Collaboration for Antepartum Risk Evaluation (CARE) Model
Acronym: CARE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04039932
Maternal Health Services, Perinatal Care
Gonder, Amhara, Ethiopia
View Trial DetailsNCT04100577
Adverse Childhood Experiences, Behavior
Madison, Wisconsin, United States
View Trial DetailsNCT07530822
Anxiety, Anxiety Disorders
Ankara, keçiören, Turkey (Türkiye)
View Trial DetailsNCT07011121
Prenatal Care
Springdale, Arkansas, United States
View Trial Details