Collaboration for Antepartum Risk Evaluation (CARE)
Interprofessional Perinatal Consults to Improve Communication Quality, Satisfaction, and Team Cohesion: A Randomized Trial of the Collaboration for Antepartum Risk Evaluation (CARE) Model
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Tennessee
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Nashville, Tennessee, Egyesült Államok, 37240
- Vanderbilt School of Nursing
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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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.
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Aktív összehasonlító: 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.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Communication Assessment Tool (CAT)-Team survey
Időkeret: 2 weeks after intervention/comparison visit
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The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
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2 weeks after intervention/comparison visit
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Satisfaction with Prenatal Care (SPC) scale
Időkeret: 2 weeks after intervention/comparison visit
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The SPC scale assesses patient satisfaction with prenatal care
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2 weeks after intervention/comparison visit
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Communication Assessment Tool (CAT)-Team survey - following birth
Időkeret: Within 2 weeks after patient gives birth
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The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
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Within 2 weeks after patient gives birth
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Satisfaction with Prenatal Care (SPC) scale - following birth
Időkeret: Within 2 weeks after patient gives birth
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The SPC scale assesses patient satisfaction with prenatal care
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Within 2 weeks after patient gives birth
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Smoking at 1st prenatal visit
Időkeret: 1 week after the patient gives birth
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1 week after the patient gives birth
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For smokers, number of cigarettes per day
Időkeret: 1 week after the patient gives birth
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Number of cigarettes per day
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1 week after the patient gives birth
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Location of birth
Időkeret: 1 week after patient gives birth
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Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route
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1 week after patient gives birth
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Provider at admission to labor and delivery
Időkeret: 1 week after patient gives birth
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Medical care provider at the time of admission in labor
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1 week after patient gives birth
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Patient & provider adherence to checklist plan
Időkeret: 1 week after patient gives birth
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Congruence between the anticipated plan of care at the time of the intervention/comparison visit and what occurred at the time of birth
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1 week after patient gives birth
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Gestational age at birth
Időkeret: 1 week after patient gives birth
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the gestational age of the baby at the time of birth - in weeks+days
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1 week after patient gives birth
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Infant birth weight
Időkeret: 1 week after patient gives birth
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Infant birth weight in grams as collected within 4 hours of birth
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1 week after patient gives birth
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Mode of birth
Időkeret: 1 week after patient gives birth
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Number of women giving birth via 1 of 4 methods: vaginal/assisted vaginal/cesarean after labor/planned cesarean
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1 week after patient gives birth
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Trial of labor after cesarean
Időkeret: 1 week after the mother gives birth
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Whether the woman was attempting a trial of labor after a previous cesarean birth
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1 week after the mother gives birth
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Vaginal birth after cesarean
Időkeret: 1 week after patient gives birth
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Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.
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1 week after patient gives birth
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Complications at birth
Időkeret: 1 week after patient gives birth
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The presence of any adverse outcomes during pregnancy, birth, postpartum, including details
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1 week after patient gives birth
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Breastfeeding at birth
Időkeret: 1 week after patient gives birth
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Breastmilk feeding of the infant at the time of birth
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1 week after patient gives birth
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Breastfeeding at discharge
Időkeret: 1 week after patient gives birth
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Breastmilk feeding of the infant at the time of discharge.
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1 week after patient gives birth
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Hospital stay postpartum
Időkeret: 1 week after patient gives birth
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Lengths of postpartum hospital stay in calendar days
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1 week after patient gives birth
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Generalized Anxiety Disorder 7-item scale (GAD-7)
Időkeret: 2 weeks after intervention/comparison visit
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Measure of anxiety level.
Scale can range from 0-21 with higher scores representing greater anxiety.
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2 weeks after intervention/comparison visit
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Generalized Anxiety Disorder 7-item scale (GAD-7)
Időkeret: Within 2 weeks after patient gives birth
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Measure of anxiety level.
Scale can range from 0-21 with higher scores representing greater anxiety.
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Within 2 weeks after patient gives birth
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Julia Phillippi, PhD, Vanderbilt School of Nursing
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 160523
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
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