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Collaboration for Antepartum Risk Evaluation (CARE)

2020年12月10日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

182

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Tennessee
      • Nashville、Tennessee、アメリカ、37240
        • Vanderbilt School of Nursing

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
アクティブコンパレータ：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Communication Assessment Tool (CAT)-Team survey
時間枠：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
時間枠：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
時間枠：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
時間枠：Within 2 weeks after patient gives birth
The SPC scale assesses patient satisfaction with prenatal care
Within 2 weeks after patient gives birth

二次結果の測定

結果測定
メジャーの説明
時間枠
Smoking at 1st prenatal visit
時間枠：1 week after the patient gives birth
1 week after the patient gives birth
For smokers, number of cigarettes per day
時間枠：1 week after the patient gives birth
Number of cigarettes per day
1 week after the patient gives birth
Location of birth
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Vanderbilt University

捜査官

  • 主任研究者：Julia Phillippi, PhD、Vanderbilt School of Nursing

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年7月1日

一次修了 (実際)

2020年10月1日

研究の完了 (実際)

2020年10月1日

試験登録日

最初に提出

2016年5月18日

QC基準を満たした最初の提出物

2016年5月25日

最初の投稿 (見積もり)

2016年5月30日

学習記録の更新

投稿された最後の更新 (実際)

2020年12月14日

QC基準を満たした最後の更新が送信されました

2020年12月10日

最終確認日

2020年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 160523

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Will share deindentified data after submission of the Data Use Agreement

IPD 共有時間枠

Will share deindentified data after submission of the Data Use Agreement

IPD 共有アクセス基準

To be determined

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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条件

まれな病気

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ダイエットサプリメント

スポンサー/協力者

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