Clinical trial NCT04850794: Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment
Official title: Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Feeding and Eating Disorders of Childhood
Keywords: early intervention
pediatric feeding
assessment
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2021-04-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Therapists will answer clinical questions about a case study (A or B, randomized order of presentation) without using the tool. They will then be presented with the tool and will answer the same clinical questions about a second case study (A or B, randomized order of presentation)
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants That Recommend Feeding Therapy
timeFrame: Immediately after reading feeding case study, within approximately 5 minutes
measure: Number of Participants That Recommend Referral to Other Providers
timeFrame: Immediately after reading feeding case study, within approximately 5 minutes
measure: Number of Participants That Recommend Referral by Specialty
timeFrame: Immediately after reading feeding case study, within approximately 5 minutes
Secondary outcomes:
measure: Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
timeFrame: Immediately after reading feeding case study, within approximately 5 minutes
measure: Number of Participants That Recommend Intervention Target Choices
timeFrame: Immediately after reading feeding case study, within approximately 5 minutes
measure: Decision Support Tool Acceptability Score
timeFrame: Immediately after using tool, within approximately 5 minutes
measure: Decision Support Tool Appropriateness Score.
timeFrame: Immediately after using tool, within approximately 5 minutes
measure: Decision Support Tool Feasibility Score.
timeFrame: Immediately after using tool, within approximately 5 minutes
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelsey Thompson, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.