IMPAC: Integrated Maternal Postpartum Appointment Combination in Mayo Clinic Health System Northwest Wisconsin
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Separate Lactation and Newborn visit
This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation.
Combined Lactation and Newborn visit
This arm is the intervention where the newborn visit with the pediatric provider is within a lactation consultant visit for a breastfeeding newborn and mother.
干预措施: Combined Newborn and Lactation Visit (Other)
结局指标
主要结局
Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.
时间窗: Duration of the study (expected 1 year)
Looking for the difference of breastfeeding continuation between the intervention and control group. Hypothesis is higher breastfeeding rates in the combined lactation/newborn visit.
次要结局
未报告次要终点
研究者
Melissa A. Thompson
Principal Investigator
Mayo Clinic