Trial Outcomes & Findings for Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment (NCT NCT04850794)
NCT ID: NCT04850794
Last Updated: 2023-03-21
Results Overview
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.
COMPLETED
NA
56 participants
Immediately after reading feeding case study, within approximately 5 minutes
2023-03-21
Participant Flow
Participant milestones
| Measure |
Case A Then Case B
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.
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Case B Then Case A
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.
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
|---|---|---|
|
Read 1st Case Study Without Tool
STARTED
|
28
|
28
|
|
Read 1st Case Study Without Tool
COMPLETED
|
28
|
28
|
|
Read 1st Case Study Without Tool
NOT COMPLETED
|
0
|
0
|
|
Read 2nd Case Study With Tool
STARTED
|
28
|
28
|
|
Read 2nd Case Study With Tool
COMPLETED
|
28
|
28
|
|
Read 2nd Case Study With Tool
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Case A Then Case B
n=28 Participants
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.
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Case B Then Case A
n=28 Participants
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.
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
28 Participants
n=28 Participants
|
28 Participants
n=28 Participants
|
56 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 Participants
n=28 Participants
|
28 Participants
n=28 Participants
|
56 Participants
n=56 Participants
|
|
Year of Graduation For Clinical Degree
1980-1989
|
1 Participants
n=28 Participants • One participant did not report this data.
|
1 Participants
n=27 Participants • One participant did not report this data.
|
2 Participants
n=55 Participants • One participant did not report this data.
|
|
Year of Graduation For Clinical Degree
1990-1999
|
5 Participants
n=28 Participants • One participant did not report this data.
|
4 Participants
n=27 Participants • One participant did not report this data.
|
9 Participants
n=55 Participants • One participant did not report this data.
|
|
Year of Graduation For Clinical Degree
2000-2009
|
1 Participants
n=28 Participants • One participant did not report this data.
|
4 Participants
n=27 Participants • One participant did not report this data.
|
5 Participants
n=55 Participants • One participant did not report this data.
|
|
Year of Graduation For Clinical Degree
2010-2019
|
21 Participants
n=28 Participants • One participant did not report this data.
|
18 Participants
n=27 Participants • One participant did not report this data.
|
39 Participants
n=55 Participants • One participant did not report this data.
|
|
Year of Graduation For Clinical Degree
2020 or later
|
0 Participants
n=28 Participants • One participant did not report this data.
|
0 Participants
n=27 Participants • One participant did not report this data.
|
0 Participants
n=55 Participants • One participant did not report this data.
|
|
Years of Pediatric Feeding Experience
2 years or less
|
4 Participants
n=28 Participants
|
4 Participants
n=28 Participants
|
8 Participants
n=56 Participants
|
|
Years of Pediatric Feeding Experience
3-5 years
|
15 Participants
n=28 Participants
|
10 Participants
n=28 Participants
|
25 Participants
n=56 Participants
|
|
Years of Pediatric Feeding Experience
6-8 years
|
2 Participants
n=28 Participants
|
7 Participants
n=28 Participants
|
9 Participants
n=56 Participants
|
|
Years of Pediatric Feeding Experience
9-11 years
|
3 Participants
n=28 Participants
|
1 Participants
n=28 Participants
|
4 Participants
n=56 Participants
|
|
Years of Pediatric Feeding Experience
12 or more years
|
4 Participants
n=28 Participants
|
6 Participants
n=28 Participants
|
10 Participants
n=56 Participants
|
PRIMARY outcome
Timeframe: Immediately after reading feeding case study, within approximately 5 minutesPopulation: Participant responses to Case A and Case B were analyzed separately.
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.
Outcome measures
| Measure |
With Decision Support Tool
n=56 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
n=56 Participants
Unaided by Decision Support Tool
|
|---|---|---|
|
Number of Participants That Recommend Feeding Therapy
Case A-"Yes" response
|
27 Participants
|
27 Participants
|
|
Number of Participants That Recommend Feeding Therapy
Case A-"No" response
|
1 Participants
|
1 Participants
|
|
Number of Participants That Recommend Feeding Therapy
Case B-"Yes" response
|
26 Participants
|
25 Participants
|
|
Number of Participants That Recommend Feeding Therapy
Case B-"No" response
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Immediately after reading feeding case study, within approximately 5 minutesPopulation: Participant responses to Case A and Case B were analyzed separately.
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.
Outcome measures
| Measure |
With Decision Support Tool
n=56 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
n=56 Participants
Unaided by Decision Support Tool
|
|---|---|---|
|
Number of Participants That Recommend Referral to Other Providers
Case A-"Yes" response
|
27 Participants
|
25 Participants
|
|
Number of Participants That Recommend Referral to Other Providers
Case A-"No" response
|
1 Participants
|
3 Participants
|
|
Number of Participants That Recommend Referral to Other Providers
Case B-"Yes" response
|
27 Participants
|
25 Participants
|
|
Number of Participants That Recommend Referral to Other Providers
Case B-"No" response
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Immediately after reading feeding case study, within approximately 5 minutesPopulation: The question was only answered by those participants who recommended referring to another professional. Participant responses to Case A and Case B were analyzed separately.
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.
Outcome measures
| Measure |
With Decision Support Tool
n=54 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
n=50 Participants
Unaided by Decision Support Tool
|
|---|---|---|
|
Number of Participants That Recommend Referral by Specialty
Case A Nutritionist/dietician
|
11 Participants
|
3 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Gastroenterologist
|
20 Participants
|
17 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Otolaryngologist (ENT)
|
2 Participants
|
4 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Aerodigestive clinic
|
9 Participants
|
1 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Pulmonologist
|
0 Participants
|
0 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Occupational therapist and speech language pathologist
|
16 Participants
|
14 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Psychologist/social worker
|
1 Participants
|
0 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Applied behavior analyst (ABA)
|
1 Participants
|
0 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Allergist
|
0 Participants
|
3 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Multi-disciplinary team
|
12 Participants
|
11 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case A-Other
|
1 Participants
|
8 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Nutritionist/dietician
|
10 Participants
|
8 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Gastroenterologist
|
15 Participants
|
11 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Otolaryngologist (ENT)
|
10 Participants
|
6 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Aerodigestive clinic
|
15 Participants
|
4 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Pulmonologist
|
1 Participants
|
1 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Occupational therapist and speech language pathologist
|
10 Participants
|
12 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Psychologist/social worker
|
1 Participants
|
0 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Applied behavior analyst (ABA)
|
2 Participants
|
0 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Allergist
|
4 Participants
|
1 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Multi-disciplinary team
|
21 Participants
|
14 Participants
|
|
Number of Participants That Recommend Referral by Specialty
Case B-Other
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Immediately after reading feeding case study, within approximately 5 minutesPopulation: The question was only answered by those participants who recommended feeding therapy. Participant responses to Case A and Case B were analyzed separately.
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.
Outcome measures
| Measure |
With Decision Support Tool
n=53 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
n=52 Participants
Unaided by Decision Support Tool
|
|---|---|---|
|
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Case B-2 times per week or more
|
12 Participants
|
13 Participants
|
|
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Case B-less than one time per week
|
0 Participants
|
0 Participants
|
|
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Case A-1 time per week
|
19 Participants
|
24 Participants
|
|
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Case A-less than one time per week
|
0 Participants
|
0 Participants
|
|
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Case B-1 time per week
|
14 Participants
|
12 Participants
|
|
Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week
Case A-2 times per week or more
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediately after reading feeding case study, within approximately 5 minutesPopulation: The question was only answered by those participants who recommended feeding therapy. Participant responses to Case A and Case B were analyzed separately.
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.
Outcome measures
| Measure |
With Decision Support Tool
n=53 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
n=52 Participants
Unaided by Decision Support Tool
|
|---|---|---|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Sensory
|
22 Participants
|
19 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Other
|
2 Participants
|
3 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Oral Motor Skills
|
26 Participants
|
25 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Behavioral
|
22 Participants
|
11 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Medication
|
4 Participants
|
5 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Modification of food/liquid
|
15 Participants
|
16 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Modification of Equipment
|
12 Participants
|
8 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Modification of Environment
|
16 Participants
|
14 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case A-Parent Coaching
|
27 Participants
|
27 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Oral Motor Skills
|
26 Participants
|
23 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Sensory
|
11 Participants
|
9 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Behavioral
|
6 Participants
|
1 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Medication
|
2 Participants
|
0 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Modification of food/liquid
|
22 Participants
|
24 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Modification of Equipment
|
26 Participants
|
24 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Modification of Environment
|
24 Participants
|
21 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Parent Coaching
|
26 Participants
|
25 Participants
|
|
Number of Participants That Recommend Intervention Target Choices
Case B-Other
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Immediately after using tool, within approximately 5 minutesThe 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).
Outcome measures
| Measure |
With Decision Support Tool
n=56 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
Unaided by Decision Support Tool
|
|---|---|---|
|
Decision Support Tool Acceptability Score
|
3.40 score on a scale
Standard Deviation 0.52
|
—
|
SECONDARY outcome
Timeframe: Immediately after using tool, within approximately 5 minutesThe 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.
Outcome measures
| Measure |
With Decision Support Tool
n=56 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
Unaided by Decision Support Tool
|
|---|---|---|
|
Decision Support Tool Appropriateness Score.
|
3.37 score on a scale
Standard Deviation 0.54
|
—
|
SECONDARY outcome
Timeframe: Immediately after using tool, within approximately 5 minutesThe 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.
Outcome measures
| Measure |
With Decision Support Tool
n=56 Participants
Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
|
Without Decision Support Tool
Unaided by Decision Support Tool
|
|---|---|---|
|
Decision Support Tool Feasibility Score.
|
3.50 score on a scale
Standard Deviation 0.57
|
—
|
Adverse Events
Case A With Decision Support Tool
Case B With Decision Support Tool
Case A Without Decision Support Tool
Case B Without Decision Support Tool
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelsey Thompson, MS
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place