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临床试验/NCT04850794
NCT04850794已完成不适用

Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年7月14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
56
试验地点
1
主要终点
Number of Participants That Recommend Feeding Therapy

研究概览

简要总结

Preterm infants are at risk for feeding problems which can persist through early childhood. These feeding problems may include oral motor, sensory, digestive, nutritional, respiratory, and/or behavioral components. In North Carolina's early intervention program, speech pathologists or occupational therapists are responsible for completing feeding evaluations, and may not know when to refer infants out to medical specialists to address these other domains. This study will test a decision support tool in hypothetical feeding evaluation scenarios. The hypothetical scenarios will consist of real feeding videos of preterm infants who recently participated in a multidisciplinary feeding evaluation. Parent-reported outcomes of the infant's real evaluation will be compared to those of the speech pathologists and occupational therapists in our study who do, and do not, use the decision support tool. The investigators hypothesize that therapists with the tool will make recommendations that are closer to those of the multidisciplinary team, and that they will find the tool useful and easy to use.

Due to recruitment limitations with families, the study was adapted in October, 2021 prior to enrollment of subjects to use case studies, rather than infant videos, as the hypothetical situation from which to test the tool. Therapists will then answer clinical questions without using the tool when viewing the first case study, and will use the tool to answer questions when viewing the second case study. Order of case study presentation will be randomized among participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •at least 18 years of age,
  • •speech language pathologist or occupational therapist,
  • •at least 2 years of experience evaluating and treating pediatric feeding,
  • •have worked in early intervention in last 5 years,
  • •English proficiency,
  • •currently reside in North Carolina

排除标准

  • •<2 years of experience in pediatric feeding,
  • •have not worked in Early Intervention in last 5 years,
  • •younger than 18 years old

研究组 & 干预措施

Case A then Case B

Experimental

Participant will first review and answer questions about Case A without using the tool. Then, they will use the tool to answer questions about case B.

干预措施: Decision Support Tool (Behavioral)

Case B then Case A

Experimental

Participant will first review and answer questions about Case B without using the tool. Then, they will use the tool to answer questions about case A.

干预措施: Decision Support Tool (Behavioral)

结局指标

主要结局

Number of Participants That Recommend Feeding Therapy

时间窗: Immediately after reading feeding case study, within approximately 5 minutes

After reading a feeding case study, early intervention professionals will answer the question "Would you recommend feeding therapy?" with two choices: yes or no. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B.

Number of Participants That Recommend Referral to Other Providers

时间窗: Immediately after reading feeding case study, within approximately 5 minutes

After reading a feeding case study, early intervention professionals will answer the question "Would you refer this family to any other providers/specialists for evaluation/treatment?" with two answer choices: yes or no. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B.

Number of Participants That Recommend Referral by Specialty

时间窗: Immediately after reading feeding case study, within approximately 5 minutes

After reading the feeding case study, early intervention professionals will answer the question "What other professionals would you refer this child to? Check all that apply." with the following choices: nutritionist/dietician, gastroenterologist, otolaryngologist (ENT), aerodigestive clinic, pulmonologist, occupational therapist, speech language pathologist, psychologist/social worker, applied behavior analyst (ABA), or allergist. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B.

次要结局

  • Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week(Immediately after reading feeding case study, within approximately 5 minutes)
  • Number of Participants That Recommend Intervention Target Choices(Immediately after reading feeding case study, within approximately 5 minutes)
  • Decision Support Tool Acceptability Score(Immediately after using tool, within approximately 5 minutes)
  • Decision Support Tool Appropriateness Score.(Immediately after using tool, within approximately 5 minutes)
  • Decision Support Tool Feasibility Score.(Immediately after using tool, within approximately 5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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