Collaboration for Antepartum Risk Evaluation

NCT02786225 | Completed DMC

• 1 other identifier: 160523
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• 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

• Location of birth

  1 week after patient gives birth

• Provider at admission to labor and delivery

  1 week after patient gives birth

• Patient & provider adherence to checklist plan

  1 week after patient gives birth

Study Arms (2)

Collaborative Care

EXPERIMENTAL

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

Comparison Care- Usual Care + primary midwife

ACTIVE COMPARATOR

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

Interventions

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.

Collaborative 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.

Comparison Care- Usual Care + primary midwife

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt School of Nursing

Nashville, Tennessee, 37240, United States

Location

Related Publications (1)

• 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.

  PMID: 29758172 DERIVED

Study Officials

• Julia Phillippi, PhD

  Vanderbilt School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 30, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will share deindentified data after submission of the Data Use Agreement
• Access Criteria: To be determined

Locations

US (1)