Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment

Study Overview
=================
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.

Official Title
-----------------
Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment

Conditions
-----------------
Premature Birth, Feeding and Eating Disorders of Childhood

Intervention / Treatment
-----------------
* Behavioral: Decision Support Tool


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case A then Case B<br>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. | Behavioral: Decision Support Tool<br>* The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.<br>|
| Experimental: Case B then Case A<br>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. | Behavioral: Decision Support Tool<br>* The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after reading feeding case study, within approximately 5 minutes | 
| 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. | Immediately after reading feeding case study, within approximately 5 minutes | 
| 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. | Immediately after reading feeding case study, within approximately 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after reading feeding case study, within approximately 5 minutes | 
| 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. | Immediately after reading feeding case study, within approximately 5 minutes | 
| 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). | Immediately after using tool, within approximately 5 minutes | 
| 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. | Immediately after using tool, within approximately 5 minutes | 
| 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. | Immediately after using tool, within approximately 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early intervention, pediatric feeding, assessment