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临床试验/NCT04985227
NCT04985227已完成不适用

Impact of Home Weight Tele-monitoring on the Number of Office Visits in the First Six

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of visits

研究概览

简要总结

Currently American Academy of Pediatrics (AAP) Bright Futures Guideline recommends 2 visits for all healthy term newborn infants in the first 6 weeks of life, first at 3-5 days of life and the second at around a month. However, compliant parents of infants are known to get at least 1-2 extra visits due to primary care provider's concern about appropriate weight gain. These weight check visits as they take up extra time, car gas, parking charges, loss of work time and paying for childcare during the visits. Clinic resources are also unnecessarily utilized. Remote home monitoring of infant weights with the use of technology could reduce the need for office visits and improve efficiency on the provider side, enhance parental satisfaction and decrease transmission of viruses in the winter season. The main objective is to monitor the daily weight of term infants born at 37 completed weeks of greater, discharged from the newborn nursery, remotely through the electronic medical record by the primary care provider and to reduce any extra visit in the first six weeks of life. Using block randomization, the infants will be assigned to either group A, where no home telemonitoring of weight will take place or group B, where the parent will be provided with a weighing scale. The parent will enter the weight into the MyChart application on the smartphone or on the computer which will be tracked by the pediatrician. The pediatrician will take the decision whether to bring the infant in for a weight check visit based on the weight information. If the weight gain is satisfactory, the pediatrician will see the patient at around 1 month of age per recommendation and the parents will stop the weight checks at that time. The sample size required was 16 on each arm (total 32) which has been increased to 20 each arm to account for technical problems and/or loss to follow up.

详细描述

Title: Impact of a pilot home weight telemonitoring program on the number of office visits by infants in the first six weeks of life

Purpose: Currently American Academy of Pediatrics (AAP)Bright Futures Guideline recommends five health supervision or office visits in the first 6 months of life for infants discharged from the newborn nursery. This includes 2 visits in the first 6 weeks, first at 3-5 days of life and the second at around a month.1 However, compliant parents of infants are known to get at least 1-2 extra visits due to primary care provider's concern about appropriate weight gain. These weight check visits are an inconvenience to the parent(s) as they not only take up extra time, but also utilize the limited resources these parents have. Travel car gas, parking charges, loss of work time and paying for childcare during the visits are some of the ways the finances are affected. There is also utilization of resources in the clinic, as well as time slots that could be utilized to see other patients. Previous studies have shown greater maternal satisfaction with effective telemonitoring of weight at home.2,3 Remote home monitoring of infant weights with the use of technology could reduce the need for office visits and improve efficiency on the provider side, enhance parental satisfaction and decrease transmission of viruses in the winter season. Reduction in the number of visits to the outpatient visit may also help in curbing the spread of coronavirus in the pandemic.

Objectives:

  1. To monitor the daily weight of infants remotely through the electronic medical record by the primary care provider.
  2. To reduce any extra visit in the first six weeks of life of an infant other than those recommended by AAP, primarily for a concern of appropriate weight gain.

Target population: Newborns with gestation of 37 weeks and zero days or more, discharged from the newborn nursery who will follow-up with a clinician within the Cleveland Clinic health system (CCHS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Born at Fairview Hospital and discharged from the newborn nursery
  • •Gestation of 37 weeks and 0 days or greater and weight appropriate for gestation age
  • •Weight loss is within the range of normal per standard guidelines for the postnatal day (need to elaborate)
  • •Parents who agree to download the patient portal application of Cleveland Clinic and have access to the infant's information on it.

排除标准

  • •Admitted to the NICU after birth
  • •Congenital malformations or complex health care issues requiring outpatient monitoring by any other provider other than the pediatrician.
  • •History of drug abuse in mother
  • •Twin or triplet birth
  • •Mother does not speak English

研究组 & 干预措施

Home weight monitoring

Experimental

Weighing scales will be provided to the parents to weigh their infant and enter the weight daily during the weekdays into the patient portal.

干预措施: Home weight monitoring (Other)

Control

No Intervention

The parents will visit their Primary Care office in the usual manner as recommended by their Pediatrician.

结局指标

主要结局

Number of visits

时间窗: 1 month

Number of visits to the Primary Care providers office in the first month of life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anirudha Das

Physician

The Cleveland Clinic

研究点 (1)

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