Collaboration for Antepartum Risk Evaluation (CARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Midwifery; Prenatal Care; Maternal Health Services; Perinatal Care; Maternal-child Health Services
• Intervention / Treatment: Behavioral: Collaborative Care; Behavioral: Comparison Care- Usual Care + primary midwife

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Vanderbilt School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Collaborative Care; 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication Assessment Tool (CAT)-Team survey	The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.	2 weeks after intervention/comparison visit
Satisfaction with Prenatal Care (SPC) scale	The SPC scale assesses patient satisfaction with prenatal care	2 weeks after intervention/comparison visit
Communication Assessment Tool (CAT)-Team survey - following birth	The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.	Within 2 weeks after patient gives birth
Satisfaction with Prenatal Care (SPC) scale - following birth	The SPC scale assesses patient satisfaction with prenatal care	Within 2 weeks after patient gives birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking at 1st prenatal visit		1 week after the patient gives birth
For smokers, number of cigarettes per day	Number of cigarettes per day	1 week after the patient gives birth
Location of birth	Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route	1 week after patient gives birth
Provider at admission to labor and delivery	Medical care provider at the time of admission in labor	1 week after patient gives birth
Patient & provider adherence to checklist plan	Congruence between the anticipated plan of care at the time of the intervention/comparison visit and what occurred at the time of birth	1 week after patient gives birth
Gestational age at birth	the gestational age of the baby at the time of birth - in weeks+days	1 week after patient gives birth
Infant birth weight	Infant birth weight in grams as collected within 4 hours of birth	1 week after patient gives birth
Mode of birth	Number of women giving birth via 1 of 4 methods: vaginal/assisted vaginal/cesarean after labor/planned cesarean	1 week after patient gives birth
Trial of labor after cesarean	Whether the woman was attempting a trial of labor after a previous cesarean birth	1 week after the mother gives birth
Vaginal birth after cesarean	Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.	1 week after patient gives birth
Complications at birth	The presence of any adverse outcomes during pregnancy, birth, postpartum, including details	1 week after patient gives birth
Breastfeeding at birth	Breastmilk feeding of the infant at the time of birth	1 week after patient gives birth
Breastfeeding at discharge	Breastmilk feeding of the infant at the time of discharge.	1 week after patient gives birth
Hospital stay postpartum	Lengths of postpartum hospital stay in calendar days	1 week after patient gives birth
Generalized Anxiety Disorder 7-item scale (GAD-7)	Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.	2 weeks after intervention/comparison visit
Generalized Anxiety Disorder 7-item scale (GAD-7)	Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.	Within 2 weeks after patient gives birth

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Julia Phillippi, PhD, Vanderbilt School of Nursing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 160523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share deindentified data after submission of the Data Use Agreement
• IPD Sharing Time Frame: Will share deindentified data after submission of the Data Use Agreement
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF