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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

Immediately after reading feeding case study, within approximately 5 minutes

Results posted on

2023-03-21

Participant Flow

Participant milestones

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

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 minutes

Population: 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

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 minutes

Population: 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

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 minutes

Population: 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

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 minutes

Population: 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

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 minutes

Population: 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

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 minutes

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).

Outcome measures

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 minutes

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.

Outcome measures

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 minutes

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Case B With Decision Support Tool

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Case A Without Decision Support Tool

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Case B Without Decision Support Tool

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 919-966-1007

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place