Clinical trial NCT06395168: Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination
Official title: IMPAC: Integrated Maternal Postpartum Appointment Combination in Mayo Clinic Health System Northwest Wisconsin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Feeding
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).

Detailed description: This interventional, comparative effectiveness study investigates the impact of integrating the first newborn outpatient provider and lactation consultant visits, potentially reducing appointments for new mothers while ensuring early lactation support. The outcomes, including breastfeeding continuation rates and maternal satisfaction, will be measured against the conventional separate visit model. The ultimate goal is to prolong breastfeeding duration, enhance care quality, improve efficiency, and enrich patient experience.

Eligibility criteria: Inclusion Criteria:

* Mothers aged greater than or equal to 18 years.
* Mothers who are able to provide informed consent for participation in this study.
* Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin.
* Mothers who have given birth within the past four days prior to enrollment into this study.
* Mothers who intend to breastfeed their newborns.
* Mothers who are willing and able to participate in this study.
* Mothers who are able to communicate in English.
* Mothers with the ability to connect to the internet and complete electronic data collection.

Exclusion Criteria:

* Mothers who are unable or unwilling to provide informed consent for participation in this study.
* Mothers less than 18 years of age.
* Mothers unable to complete study procedures or follow-up visits.
* Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction).
* Mothers who have no intention to breastfeed their newborns.
* Mothers who are unwilling to follow up with lactation.
* Infants who have already had their first postpartum outpatient provider visit.
* Pre-term infants (less than 37 weeks).
* Special care admission greater than two days.
* Length of stay or anticipated LOS greater than four days.
* Transfer to an outside facility.
* Inability to communicate in English.
* When slots are no longer available.

Primary outcomes:
measure: Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.
timeFrame: Duration of the study (expected 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Eau Claire
country: United States
facility: Mayo Clinic Health System-Eau Claire Clinic
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Karen Myhre
role: PRINCIPAL_INVESTIGATOR
References: