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Collaboration for Antepartum Risk Evaluation (CARE)

10 december 2020 bijgewerkt door: Julia Phillippi, Vanderbilt University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

182

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37240
        • Vanderbilt School of Nursing

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Communication Assessment Tool (CAT)-Team survey
Tijdsspanne: 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 weeks after intervention/comparison visit
Satisfaction with Prenatal Care (SPC) scale
Tijdsspanne: 2 weeks after intervention/comparison visit
The SPC scale assesses patient satisfaction with prenatal care
2 weeks after intervention/comparison visit
Communication Assessment Tool (CAT)-Team survey - following birth
Tijdsspanne: 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.
Within 2 weeks after patient gives birth
Satisfaction with Prenatal Care (SPC) scale - following birth
Tijdsspanne: Within 2 weeks after patient gives birth
The SPC scale assesses patient satisfaction with prenatal care
Within 2 weeks after patient gives birth

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Smoking at 1st prenatal visit
Tijdsspanne: 1 week after the patient gives birth
1 week after the patient gives birth
For smokers, number of cigarettes per day
Tijdsspanne: 1 week after the patient gives birth
Number of cigarettes per day
1 week after the patient gives birth
Location of birth
Tijdsspanne: 1 week after patient gives 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
Tijdsspanne: 1 week after patient gives birth
Medical care provider at the time of admission in labor
1 week after patient gives birth
Patient & provider adherence to checklist plan
Tijdsspanne: 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
1 week after patient gives birth
Gestational age at birth
Tijdsspanne: 1 week after patient gives birth
the gestational age of the baby at the time of birth - in weeks+days
1 week after patient gives birth
Infant birth weight
Tijdsspanne: 1 week after patient gives birth
Infant birth weight in grams as collected within 4 hours of birth
1 week after patient gives birth
Mode of birth
Tijdsspanne: 1 week after patient gives 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
Tijdsspanne: 1 week after the mother gives birth
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
Tijdsspanne: 1 week after patient gives birth
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
Tijdsspanne: 1 week after patient gives birth
The presence of any adverse outcomes during pregnancy, birth, postpartum, including details
1 week after patient gives birth
Breastfeeding at birth
Tijdsspanne: 1 week after patient gives birth
Breastmilk feeding of the infant at the time of birth
1 week after patient gives birth
Breastfeeding at discharge
Tijdsspanne: 1 week after patient gives birth
Breastmilk feeding of the infant at the time of discharge.
1 week after patient gives birth
Hospital stay postpartum
Tijdsspanne: 1 week after patient gives birth
Lengths of postpartum hospital stay in calendar days
1 week after patient gives birth
Generalized Anxiety Disorder 7-item scale (GAD-7)
Tijdsspanne: 2 weeks after intervention/comparison visit
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)
Tijdsspanne: Within 2 weeks after patient gives birth
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Within 2 weeks after patient gives birth

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University

Onderzoekers

  • Hoofdonderzoeker: Julia Phillippi, PhD, Vanderbilt School of Nursing

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2016

Primaire voltooiing (Werkelijk)

1 oktober 2020

Studie voltooiing (Werkelijk)

1 oktober 2020

Studieregistratiedata

Eerst ingediend

18 mei 2016

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2016

Eerst geplaatst (Schatting)

30 mei 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 december 2020

Laatste update ingediend die voldeed aan QC-criteria

10 december 2020

Laatst geverifieerd

1 december 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 160523

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Will share deindentified data after submission of the Data Use Agreement

IPD-tijdsbestek voor delen

Will share deindentified data after submission of the Data Use Agreement

IPD-toegangscriteria voor delen

To be determined

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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