Collaboration for Antepartum Risk Evaluation

Prenatal Care Clinical Trial

— CARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786225
• Other study ID #: 160523
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 2020

Study information

• Verified date: December 2020
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maternal Health Services
• Maternal-child Health Services
• Midwifery
• Perinatal Care
• Prenatal Care

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt School of Nursing	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Satisfaction with Prenatal Care (SPC) scale	The SPC scale assesses patient satisfaction with prenatal care	2 weeks after intervention/comparison visit
Primary	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
Primary	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	Smoking at 1st prenatal visit		1 week after the patient gives birth
Secondary	For smokers, number of cigarettes per day	Number of cigarettes per day	1 week after the patient gives birth
Secondary	Location of birth	Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route	1 week after patient gives birth
Secondary	Provider at admission to labor and delivery	Medical care provider at the time of admission in labor	1 week after patient gives birth
Secondary	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
Secondary	Gestational age at birth	the gestational age of the baby at the time of birth - in weeks+days	1 week after patient gives birth
Secondary	Infant birth weight	Infant birth weight in grams as collected within 4 hours of birth	1 week after patient gives birth
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications at birth	The presence of any adverse outcomes during pregnancy, birth, postpartum, including details	1 week after patient gives birth
Secondary	Breastfeeding at birth	Breastmilk feeding of the infant at the time of birth	1 week after patient gives birth
Secondary	Breastfeeding at discharge	Breastmilk feeding of the infant at the time of discharge.	1 week after patient gives birth
Secondary	Hospital stay postpartum	Lengths of postpartum hospital stay in calendar days	1 week after patient gives birth
Secondary	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
Secondary	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