Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment
Primary Purpose
Premature Birth, Feeding and Eating Disorders of Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Support Tool
Sponsored by
About this trial
This is an interventional screening trial for Premature Birth focused on measuring early intervention, pediatric feeding, assessment
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Case A then Case B
Case B then Case A
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants That Recommend Feeding Therapy
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
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
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.
Secondary Outcome Measures
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "With what frequency would you recommend therapy?" with three choices: 2 times per week or more, 1 time per week, less than one time per week. 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 Intervention Target Choices
After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "What therapy targets might you include for this child?" and may check all that apply from the following choices: oral motor skills, sensory, behavioral, medication, modification of food/liquid, modification of equipment (seating, utensils, etc.), modification of environment (location, distractions, routine, etc.), parent coaching, or other. 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.
Decision Support Tool Acceptability Score
The Acceptability of Intervention Measure (AIM) will be used to measure acceptability of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) meets my approval; (Intervention) is appealing to me; I like (Intervention) and I welcome (Intervention).
Decision Support Tool Appropriateness Score.
The Intervention Appropriateness Measure (IAM) will be used to measure appropriateness of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems fitting; (Intervention) seems suitable; (Intervention) seems applicable; (Intervention) seems like a good match.
Decision Support Tool Feasibility Score.
The Feasibility of Intervention Measure (FIM) will be used to measure feasibility of use of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems implementable; (Intervention) seems possible; (Intervention) seems doable; (Intervention) seems easy to use.
Full Information
NCT ID
NCT04850794
First Posted
April 14, 2021
Last Updated
March 15, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
1. Study Identification
Unique Protocol Identification Number
NCT04850794
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Feeding and Eating Disorders of Childhood
Keywords
early intervention, pediatric feeding, assessment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
Care Provider
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case A then Case B
Arm Type
Experimental
Arm Description
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.
Arm Title
Case B then Case A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Decision Support Tool
Intervention Description
The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
Primary Outcome Measure Information:
Title
Number of Participants That Recommend Feeding Therapy
Description
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.
Time Frame
Immediately after reading feeding case study, within approximately 5 minutes
Title
Number of Participants That Recommend Referral to Other Providers
Description
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.
Time Frame
Immediately after reading feeding case study, within approximately 5 minutes
Title
Number of Participants That Recommend Referral by Specialty
Description
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.
Time Frame
Immediately after reading feeding case study, within approximately 5 minutes
Secondary Outcome Measure Information:
Title
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Description
After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "With what frequency would you recommend therapy?" with three choices: 2 times per week or more, 1 time per week, less than one time per week. 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.
Time Frame
Immediately after reading feeding case study, within approximately 5 minutes
Title
Number of Participants That Recommend Intervention Target Choices
Description
After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "What therapy targets might you include for this child?" and may check all that apply from the following choices: oral motor skills, sensory, behavioral, medication, modification of food/liquid, modification of equipment (seating, utensils, etc.), modification of environment (location, distractions, routine, etc.), parent coaching, or other. 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.
Time Frame
Immediately after reading feeding case study, within approximately 5 minutes
Title
Decision Support Tool Acceptability Score
Description
The Acceptability of Intervention Measure (AIM) will be used to measure acceptability of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) meets my approval; (Intervention) is appealing to me; I like (Intervention) and I welcome (Intervention).
Time Frame
Immediately after using tool, within approximately 5 minutes
Title
Decision Support Tool Appropriateness Score.
Description
The Intervention Appropriateness Measure (IAM) will be used to measure appropriateness of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems fitting; (Intervention) seems suitable; (Intervention) seems applicable; (Intervention) seems like a good match.
Time Frame
Immediately after using tool, within approximately 5 minutes
Title
Decision Support Tool Feasibility Score.
Description
The Feasibility of Intervention Measure (FIM) will be used to measure feasibility of use of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems implementable; (Intervention) seems possible; (Intervention) seems doable; (Intervention) seems easy to use.
Time Frame
Immediately after using tool, within approximately 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelsey Thompson, MS
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
The investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with the University of North Carolina.
Citations:
PubMed Identifier
28851459
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.
Results Reference
background
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Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment
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