Prenatal CareCARENCT02786225
Collaboration for Antepartum Risk Evaluation
A study testing Collaborative Care in people with Prenatal Care and Maternal-child Health Services, run by Vanderbilt University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal Care, Maternal-child Health Services, Maternal Health Services
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt School of Nursing
Nashville, Tennessee, 37240
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Prenatal Care, Maternal-child Health Services, Maternal Health Services, Perinatal Care, Midwifery
- Being tested
- Collaborative Care, Comparison Care- Usual Care + primary midwife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
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.
Comparison Care- Usual Care + primary midwifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care | Experimental | 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. Receives: Behavioral: Collaborative Care |
| Comparison Care- Usual Care + primary midwife | Active comparator | 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. Receives: Behavioral: Comparison Care- Usual Care + primary midwife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Assessment Tool (CAT)-Team survey
The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
Measured: 2 weeks after intervention/comparison visit
Satisfaction with Prenatal Care (SPC) scale
The SPC scale assesses patient satisfaction with prenatal care
Measured: 2 weeks after intervention/comparison visit
Communication Assessment Tool (CAT)-Team survey - following birth
The CAT, developed by Makoul et al., assesses views of provider communication via 14 Likert responses ranging from 1= 'poor' to 5= 'excellent.
Measured: Within 2 weeks after patient gives birth
Satisfaction with Prenatal Care (SPC) scale - following birth
The SPC scale assesses patient satisfaction with prenatal care
Measured: Within 2 weeks after patient gives birth
Secondary outcomes (16)
Smoking at 1st prenatal visit
Measured: 1 week after the patient gives birth
For smokers, number of cigarettes per day
Number of cigarettes per day
Measured: 1 week after the patient gives birth
Location of birth
Location where the mother gave birth - Vanderbilt / Other hospital, Birth center, Home, En Route
Measured: 1 week after patient gives birth
Provider at admission to labor and delivery
Medical care provider at the time of admission in labor
Measured: 1 week after patient gives birth
Patient & provider adherence to checklist plan
Congruence between the anticipated plan of care at the time of the intervention/comparison visit and what occurred at the time of birth
Measured: 1 week after patient gives birth
Gestational age at birth
the gestational age of the baby at the time of birth - in weeks+days
Measured: 1 week after patient gives birth
Infant birth weight
Infant birth weight in grams as collected within 4 hours of birth
Measured: 1 week after patient gives birth
Mode of birth
Number of women giving birth via 1 of 4 methods: vaginal/assisted vaginal/cesarean after labor/planned cesarean
Measured: 1 week after patient gives birth
Trial of labor after cesarean
Whether the woman was attempting a trial of labor after a previous cesarean birth
Measured: 1 week after the mother gives birth
Vaginal birth after cesarean
Whether the woman gave birth vaginally with this infant after she had a previous cesarean birth.
Measured: 1 week after patient gives birth
Complications at birth
The presence of any adverse outcomes during pregnancy, birth, postpartum, including details
Measured: 1 week after patient gives birth
Breastfeeding at birth
Breastmilk feeding of the infant at the time of birth
Measured: 1 week after patient gives birth
Breastfeeding at discharge
Breastmilk feeding of the infant at the time of discharge.
Measured: 1 week after patient gives birth
Hospital stay postpartum
Lengths of postpartum hospital stay in calendar days
Measured: 1 week after patient gives birth
Generalized Anxiety Disorder 7-item scale (GAD-7)
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Measured: 2 weeks after intervention/comparison visit
Generalized Anxiety Disorder 7-item scale (GAD-7)
Measure of anxiety level. Scale can range from 0-21 with higher scores representing greater anxiety.
Measured: Within 2 weeks after patient gives birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Phillippi, Vanderbilt University
- Investigators
- Julia Phillippi, PhD, Principal investigator, Vanderbilt School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786225
- Sponsor's protocol ID
- 160523
- Acronym
- CARE
- Status last verified
- Dec 2020
- First submitted
- 18 May 2016
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Will share deindentified data after submission of the Data Use Agreement
Publications
Phillippi JC, Doersam JK, Neal JL, Roumie CL. Electronic Informed Consent to Facilitate Recruitment of Pregnant Women Into Research. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):529-534. doi: 10.1016/j.jogn.2018.04.134.
PubMed 29758172
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Perinatal Consults to Improve Communication Quality, Satisfaction, and Team Cohesion: A Randomized Trial of the Collaboration for Antepartum Risk Evaluation (CARE) Model
- ClinicalTrials.gov ID
- NCT02786225
- Acronym / sponsor ID
- CARE / 160523
- Conditions
- Prenatal Care, Maternal-child Health Services, Maternal Health Services, Perinatal Care, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care | Experimental | Behavioral: Collaborative CareIntervention 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. |
| Comparison Care- Usual Care + primary midwife | Active comparator | Behavioral: Comparison Care- Usual Care + primary midwifeComparison 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative CareIntervention 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. | Behavioural | Collaborative Care |
| Comparison Care- Usual Care + primary midwifeComparison 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. | Behavioural | Comparison Care- Usual Care + primary midwife |
Primary outcome
Communication Assessment Tool (CAT)-Team survey
Time frame: 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.
Satisfaction with Prenatal Care (SPC) scale
Time frame: 2 weeks after intervention/comparison visit
The SPC scale assesses patient satisfaction with prenatal care
Communication Assessment Tool (CAT)-Team survey - following birth
Time frame: 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.
Satisfaction with Prenatal Care (SPC) scale - following birth
Time frame: Within 2 weeks after patient gives birth
The SPC scale assesses patient satisfaction with prenatal care
16 secondary outcomes
Smoking at 1st prenatal visit
Time frame: 1 week after the patient gives birth
For smokers, number of cigarettes per day
Time frame: 1 week after the patient gives birth
Location of birth
Time frame: 1 week after patient gives birth
Provider at admission to labor and delivery
Time frame: 1 week after patient gives birth
Patient & provider adherence to checklist plan
Time frame: 1 week after patient gives birth
Gestational age at birth
Time frame: 1 week after patient gives birth
Infant birth weight
Time frame: 1 week after patient gives birth
Mode of birth
Time frame: 1 week after patient gives birth
Trial of labor after cesarean
Time frame: 1 week after the mother gives birth
Vaginal birth after cesarean
Time frame: 1 week after patient gives birth
Complications at birth
Time frame: 1 week after patient gives birth
Breastfeeding at birth
Time frame: 1 week after patient gives birth
Breastfeeding at discharge
Time frame: 1 week after patient gives birth
Hospital stay postpartum
Time frame: 1 week after patient gives birth
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: 2 weeks after intervention/comparison visit
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Within 2 weeks after patient gives birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 29758172Phillippi JC, Doersam JK, Neal JL, Roumie CL. Electronic Informed Consent to Facilitate Recruitment of Pregnant Women Into Research. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):529-534. doi: 10.1016/j.jogn.2018.04.134.
- Individual participant dataSharing planned: Yes. Will share deindentified data after submission of the Data Use Agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Phillippi, PhD principal investigator
Vanderbilt School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care in people with Prenatal Care and Maternal-child Health Services, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Assessment Tool (CAT)-Team survey (time frame: 2 weeks after intervention/comparison visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.