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Clinical Trials/NCT02786225
NCT02786225
Completed
Not Applicable

Interprofessional Perinatal Consults to Improve Communication Quality, Satisfaction, and Team Cohesion: A Randomized Trial of the Collaboration for Antepartum Risk Evaluation (CARE) Model

Vanderbilt University1 site in 1 country182 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prenatal Care
Sponsor
Vanderbilt University
Enrollment
182
Locations
1
Primary Endpoint
Satisfaction with Prenatal Care (SPC) scale
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
October 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julia Phillippi

Assistant Professor

Vanderbilt University

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

Outcomes

Primary Outcomes

Satisfaction with Prenatal Care (SPC) scale

Time Frame: 2 weeks after intervention/comparison visit

The SPC scale assesses patient satisfaction with prenatal care

Communication Assessment Tool (CAT)-Team survey

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.

Communication Assessment Tool (CAT)-Team survey - following birth

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.

Satisfaction with Prenatal Care (SPC) scale - following birth

Time Frame: Within 2 weeks after patient gives birth

The SPC scale assesses patient satisfaction with prenatal care

Secondary Outcomes

  • Trial of labor after cesarean(1 week after the mother gives birth)
  • Breastfeeding at birth(1 week after patient gives 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)
  • Provider at admission to labor and delivery(1 week after patient gives birth)
  • Gestational age at birth(1 week after patient gives birth)
  • Infant birth weight(1 week after patient gives birth)
  • Mode of birth(1 week after patient gives birth)
  • Generalized Anxiety Disorder 7-item scale (GAD-7)(Within 2 weeks after patient gives birth)
  • Patient & provider adherence to checklist plan(1 week after patient gives birth)
  • Breastfeeding at discharge(1 week after patient gives birth)
  • Hospital stay postpartum(1 week after patient gives birth)
  • Location of birth(1 week after patient gives birth)
  • Vaginal birth after cesarean(1 week after patient gives birth)
  • Complications at birth(1 week after patient gives birth)

Study Sites (1)

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