Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment

NCT04850794 | Completed Results

• 1 other identifier: 20-2786
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Feeding and Eating Disorders of Childhood

Keywords

early intervention; pediatric feeding; assessment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week

  Immediately after reading feeding case study, within approximately 5 minutes

• Number of Participants That Recommend Intervention Target Choices

  Immediately after reading feeding case study, within approximately 5 minutes

• Decision Support Tool Acceptability Score

  Immediately after using tool, within approximately 5 minutes

• Decision Support Tool Appropriateness Score.

  Immediately after using tool, within approximately 5 minutes

• Decision Support Tool Feasibility Score.

  Immediately after using tool, within approximately 5 minutes

Study Arms (2)

Case A then Case B

EXPERIMENTAL

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

Case B then Case A

EXPERIMENTAL

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

Interventions

Decision Support Tool BEHAVIORAL

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 A then Case B; Case B then Case A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

• 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.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Feeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: Kelsey Thompson, MS
• Organization: University of North Carolina at Chapel Hill

kelsey_thompson@med.unc.edu

919-966-1007

Study Officials

• Kelsey Thompson, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: July 14, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 8, 2022
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)