OB Nest; Redefining Continuity of Care for Expectant Mothers

Pregnancy Clinical Trial

Official title:

Implementation and Evaluation of the OB Nest Project at the Point of Care: Redefining Continuity of Care for Expectant Mothers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082275
• Other study ID #: 13-009513
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: January 7, 2016
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study defines a new model of prenatal care called OB Nest which will be compared to the traditional model of prenatal care. OB nest is intended to create an experience for patients that feels more connected and patient-centered, allowing the patient to visit the clinic less frequently while offering increased communication with the OB nurses and providers through new tools provided to the patient. The goal of the project is to promote patient-centered care through a new prenatal care program based on constant and direct support from a nursing team, meeting the on-demand needs of expecting mothers as they rise, and as thus, redesigning the need and timing of on-site appointment with providers. Pregnant women randomized to the OB Nest cohort will see the number of pre-planned visits with their providers decreased and replaced with more direct and constant support and interaction with an assigned nursing team.

Description:

OB Nest is a model designed to promote increased patient-centered care during pregnancy. OB Nest care will allow for more flexibility, decrease interruptions to your productivity, while continuing to maintain safety for you and your infant. This model of care is anticipated to allow you more access to your health care team during your pregnancy.

This study will compare OB Nest, a new model of prenatal care, to the existing traditional model of prenatal care. The plan is to have about 300 low-risk mothers take part in this study. Eligible patients will be randomized to one of two groups; The Traditional Prenatal care Group or the OB Nest Group. Mothers will have an equal chance of being assigned to the OB Nest group. Mothers randomized to the OB Nest intervention will be assigned to a nursing care team comprised of one to three nurses and see their initial eleven planned appointments with their provider reduced to six. Mothers will still be able to request additional in-office visits with their provider and/or the provider require additional in-office visits to monitor mother and infants safety/care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years of age

• Documented gestational age less than 13 weeks.

• Pregnancy documented as low risk (See high risk exclusion criteria below)

• Able to read and understand English

• Able to provide informed consent (i.e. no impairments or barriers)

Exclusion Criteria:

Clinical judgment that determines that the pregnancy is at high risk for complications.

Any of the following high risk factors would disqualify the mother for the study:

• Severe hypertension (>160/110)

• Possible ectopic

• Congenital adrenal hypertension

• Prior PE/DVT/stroke

• Anticoagulation during prior pregnancy (e.g. antiphospholipid antibody syndrome)

• Prosthetic heart valve (non-bio)

• Pulmonary hypertension

• Mothers currently taking Immunosuppressants, Prednisone > 10mg per day, antipsychotic (e.g. lithium, Haldol, Zyprexa), chemotherapy

• Recurrent pregnancy loss (>2 losses)

• Current maternal malignancy

• Prior myocardial infarction/cardiomyopathy

• Bio-prosthetic heart valves

• Marfan syndrome

• Active liver disease (e.g. hepatitis)

• Congenital heart disease

• Coagulopathies including thrombophilias and bleeding disorders.

• Pre-existing diabetes

• Genetic disease/CF testing/anomalies in prior child

• Incompetent cervix (prior cerclage)

• Triplets or quads diagnosed by REI or ultrasound.

• Isoimmunization (Rh, Kell, etc.)

• History of transplant or currently on Dialysis

• Recurrent pregnancy loss (antiphospholipid antibody syndrome or collagen vascular disease)

• Chronic hypertension

• Prior 2nd or 3rd trimester loss

• HIV

• Inflammatory bowel disease

• Asthma and currently on steroid to control disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• OB Nest
Reduction in the number of clinic office visits Assignment to a specific nursing care team Support and direct interaction available through tools which supports mom's empowerment to address her concerns, care for herself and connect with OB as necessary between clinic visits. Empower and enable mothers to complete at home measurements for fetal heart rate, weight, and blood pressures. Augmentation of in-person visits between care providers and patients with video conversations. Maternal outcomes will be monitored through surveys and questionnaires.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expectant mothers satisfaction of prenatal care	At 36 weeks the expectant mother will complete a survey that assessed their satisfaction of the prenatal care received using a validated scale.	36 weeks	Yes