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Collaboration for Antepartum Risk Evaluation (CARE)

10. prosince 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

182

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37240
        • Vanderbilt School of Nursing

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Aktivní komparátor: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Communication Assessment Tool (CAT)-Team survey
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Within 2 weeks after patient gives birth
The SPC scale assesses patient satisfaction with prenatal care
Within 2 weeks after patient gives birth

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Smoking at 1st prenatal visit
Časové okno: 1 week after the patient gives birth
1 week after the patient gives birth
For smokers, number of cigarettes per day
Časové okno: 1 week after the patient gives birth
Number of cigarettes per day
1 week after the patient gives birth
Location of birth
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vanderbilt University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Julia Phillippi, PhD, Vanderbilt School of Nursing

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2016

Primární dokončení (Aktuální)

1. října 2020

Dokončení studie (Aktuální)

1. října 2020

Termíny zápisu do studia

První předloženo

18. května 2016

První předloženo, které splnilo kritéria kontroly kvality

25. května 2016

První zveřejněno (Odhad)

30. května 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. prosince 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. prosince 2020

Naposledy ověřeno

1. prosince 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 160523

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Will share deindentified data after submission of the Data Use Agreement

Časový rámec sdílení IPD

Will share deindentified data after submission of the Data Use Agreement

Kritéria přístupu pro sdílení IPD

To be determined

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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