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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37240
- Vanderbilt School of Nursing
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Communication Assessment Tool (CAT)-Team survey
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Smoking at 1st prenatal visit
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Julia Phillippi, PhD, Vanderbilt School of Nursing
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 160523
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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