Clinical trial NCT02786225: Collaboration for Antepartum Risk Evaluation
Official title: Interprofessional Perinatal Consults to Improve Communication Quality, Satisfaction, and Team Cohesion: A Randomized Trial of the Collaboration for Antepartum Risk Evaluation (CARE) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Care
Maternal-child Health Services
Maternal Health Services
Perinatal Care
Midwifery
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Communication Assessment Tool (CAT)-Team survey
timeFrame: 2 weeks after intervention/comparison visit
measure: Satisfaction with Prenatal Care (SPC) scale
timeFrame: 2 weeks after intervention/comparison visit
measure: Communication Assessment Tool (CAT)-Team survey - following birth
timeFrame: Within 2 weeks after patient gives birth
measure: Satisfaction with Prenatal Care (SPC) scale - following birth
timeFrame: Within 2 weeks after patient gives birth
Secondary outcomes:
measure: Smoking at 1st prenatal visit
timeFrame: 1 week after the patient gives birth
measure: For smokers, number of cigarettes per day
timeFrame: 1 week after the patient gives birth
measure: Location of birth
timeFrame: 1 week after patient gives birth
measure: Provider at admission to labor and delivery
timeFrame: 1 week after patient gives birth
measure: Patient & provider adherence to checklist plan
timeFrame: 1 week after patient gives birth
measure: Gestational age at birth
timeFrame: 1 week after patient gives birth
measure: Infant birth weight
timeFrame: 1 week after patient gives birth
measure: Mode of birth
timeFrame: 1 week after patient gives birth
measure: Trial of labor after cesarean
timeFrame: 1 week after the mother gives birth
measure: Vaginal birth after cesarean
timeFrame: 1 week after patient gives birth
measure: Complications at birth
timeFrame: 1 week after patient gives birth
measure: Breastfeeding at birth
timeFrame: 1 week after patient gives birth
measure: Breastfeeding at discharge
timeFrame: 1 week after patient gives birth
measure: Hospital stay postpartum
timeFrame: 1 week after patient gives birth
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 2 weeks after intervention/comparison visit
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Within 2 weeks after patient gives birth
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt School of Nursing
state: Tennessee
Study officials:
affiliation: Vanderbilt School of Nursing
name: Julia Phillippi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillippi JC, Doersam JK, Neal JL, Roumie CL. Electronic Informed Consent to Facilitate Recruitment of Pregnant Women Into Research. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):529-534. doi: 10.1016/j.jogn.2018.04.134.