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Completed

NCT Number: NCT02786225

Collaboration for Antepartum Risk Evaluation

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt School of Nursing

Nashville, Tennessee, 37240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collaborative care

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. Satisfaction with Prenatal Care (SPC) scale

    Time frame: 2 weeks after intervention/comparison visit

    The SPC scale assesses patient satisfaction with prenatal care

  3. 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.

  4. 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

  1. Smoking at 1st prenatal visit

    Time frame: 1 week after the patient gives birth

  2. For smokers, number of cigarettes per day

    Time frame: 1 week after the patient gives birth

    Number of cigarettes per day

  3. Location of birth

    Time frame: 1 week after patient gives birth

    Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route

  4. Provider at admission to labor and delivery

    Time frame: 1 week after patient gives birth

    Medical care provider at the time of admission in labor

  5. Patient & provider adherence to checklist plan

    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

  6. Gestational age at birth

    Time frame: 1 week after patient gives birth

    the gestational age of the baby at the time of birth - in weeks+days

  7. Infant birth weight

    Time frame: 1 week after patient gives birth

    Infant birth weight in grams as collected within 4 hours of birth

  8. Mode 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

  9. Trial of labor after cesarean

    Time frame: 1 week after the mother gives birth

    Whether the woman was attempting a trial of labor after a previous cesarean birth

  10. Vaginal birth after cesarean

    Time frame: 1 week after patient gives birth

    Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.

  11. Complications at birth

    Time frame: 1 week after patient gives birth

    The presence of any adverse outcomes during pregnancy, birth, postpartum, including details

  12. Breastfeeding at birth

    Time frame: 1 week after patient gives birth

    Breastmilk feeding of the infant at the time of birth

  13. Breastfeeding at discharge

    Time frame: 1 week after patient gives birth

    Breastmilk feeding of the infant at the time of discharge.

  14. Hospital stay postpartum

    Time frame: 1 week after patient gives birth

    Lengths of postpartum hospital stay in calendar days

  15. Generalized Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 2 weeks after intervention/comparison visit

    Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.

  16. Generalized Anxiety Disorder 7-item scale (GAD-7)

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 30, 2016
Registry last updated
Dec 14, 2020

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.

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