OB Nest; Redefining Continuity of Care for Expectant Mothers

NCT02082275 | Completed

• 1 other identifier: 13-009513
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

Prenatal Care; Obstetrics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

OB Nest

EXPERIMENTAL

OB Nest is designed to reduce the number of pre-planned visits with their OB provider and replace the in-clinic visits with a direct and constant support from an assigned nursing team. OB Nest will empower moms-to-be to take ownership of their prenatal care by providing a wealth of resources.

Other: OB Nest

Traditional Prenatal care

NO INTERVENTION

Traditional prenatal visits in clinic with OB providers.

Interventions

OB Nest OTHER

* 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.

OB Nest

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Documented gestational age less than 13 weeks.

You may not qualify if:

• Able to read and understand English
• Able to provide informed consent (i.e. no impairments or barriers)
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Theiler RN, Butler-Tobah Y, Hathcock MA, Famuyide A. OB Nest randomized controlled trial: a cost comparison of reduced visit compared to traditional prenatal care. BMC Pregnancy Childbirth. 2021 Jan 21;21(1):71. doi: 10.1186/s12884-021-03557-3.

  PMID: 33478433 DERIVED

• Butler Tobah YS, LeBlanc A, Branda ME, Inselman JW, Morris MA, Ridgeway JL, Finnie DM, Theiler R, Torbenson VE, Brodrick EM, Meylor de Mooij M, Gostout B, Famuyide A. Randomized comparison of a reduced-visit prenatal care model enhanced with remote monitoring. Am J Obstet Gynecol. 2019 Dec;221(6):638.e1-638.e8. doi: 10.1016/j.ajog.2019.06.034. Epub 2019 Jun 19.

  PMID: 31228414 DERIVED

• Ridgeway JL, LeBlanc A, Branda M, Harms RW, Morris MA, Nesbitt K, Gostout BS, Barkey LM, Sobolewski SM, Brodrick E, Inselman J, Baron A, Sivly A, Baker M, Finnie D, Chaudhry R, Famuyide AO. Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. BMC Pregnancy Childbirth. 2015 Dec 2;15:323. doi: 10.1186/s12884-015-0762-2.

  PMID: 26631000 DERIVED

Study Officials

• Abimbola Famuyide, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics-Gynecology

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)