Clinical trial NCT06052891: CHAMP For the Feeder: Tube Feeding Study
Official title: CHAMP For the Feeder: Pilot for CHAMP App Tube Weaning
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Feeding Disorders
Keywords: Pediatric
Feeding difficulties
Tube weaning
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
name: Children's Mercy Hospital Kansas City
First posted: 2023-09-25
Enrollment: 245
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Interdisciplinary Feeding Clinic (IDC) patient population that are deemed ready to begin weaning from tube feeds.

Brief summary: Single site evidence-based implementation of a mHealth application for remote patient monitoring for pediatric patients ready to wean from tube feedings (TFs). The primary objective of this study is to evaluate the CHAMP® ("CHAMP App") software platforms' expansion into TF weaning through Children's Mercy (CM) Kansas City's interdisciplinary feeding team (IDC). The investigators will use the current standard of care rates of tube weaning success, time to weaning, and healthcare team communication to evaluate the change after the implementation of the evidence-based CHAMP App. For equipoise of access, the study team will provide access in this pre-post design for parent/legally authorized representative (LAR)- child family access and use the CHAMP App software platform as soon as possible.

Detailed description: Training: After consent to the study- parents/LAR will undergo training on the CHAMP App use by the study staff. The CHAMP App will be downloaded on the parent/LAR mobile device or an iPad that has been locked to contain only the CHAMP App and patient portal with mobile device management of the device by CM.

In addition to approval to begin a weaning trial by the IDC team providing primary nutrition management-beginning the weaning process may include these requirements:

* Weight for length or body mass index (BMI) must be stable. For children who are premature, syndromic, small for gestational age, or intrauterine growth restriction patients, this is at the dietitian's and provider's discretion. For typically developing patients, weight for length BMI z-score must be \> -2.
* . Weekly feeding therapy is not required for tube weaning but will be strongly encouraged.
* A feeding therapist has assessed oral motor skills and agrees that the patient has sufficient skills to take all their calories by mouth.

CHAMP App use: Families will be provided with a weighing scale for home use; access to the CHAMP App mobile application or an iPad with the app and myChildren's Mercy App (patient portal) installed, if they prefer, during the study period. Data quality and validity will be ensured through the training of the healthcare team on data entry and out-of-range limits for each data value collected via the CHAMP web portal data entry forms. All data will be stored on the secure CM CHAMP Azure software platform with secure encryption database features.

Healthcare team CHAMP web portal use: The study team will review data entered by parents twice a week and as needed with questions and red flag concerns reported by parents/LAR. They will communicate back to parents with messages in the patient portal for documentation of messages that can be seen by other gastroenterology (GI) staff (GI clinic messages).

The IDC tube weaning algorithm (attached) will be used as a guideline for awareness of tube weaning but any changes to volume, concentration, or formula type will be reviewed and approved by an IDC provider before communicating to families.

RPM data entered by parents will be reviewed weekly by the IDC healthcare team in a team meeting organized through weekly reports of active patients enrolled in the study. This meeting will include an IDC provider, nurse, and nutritionist at minimum. There will be a summary of full study patient reports and individual patient reports available to all healthcare team members throughout the study, and these reports will be especially useful during these weekly meetings.

The IDC team works with Gastroenterology staff and fellows for 24 hours a day call. The CHAMP app will have a service pager for GI and the on-call hospital network is also available at any time for parents/LAR. On-call GI staff will be able to see feeding and weight data in Cerner under results review and CHAMP App. Videos are only available in the CHAMP web portal at champ.childrensmercy.org

Recommendation and timing for removal of feeding tubes will be up to the healthcare team alone. This event will be documented for date/time but is not a study-related intervention recommended through CHAMP App.

Additional measures to evaluate study results include:

Demographics - child and family measures: The study team will collect data on the child and family from the electronic medical record, including, but not limited to, infant medical conditions, feeding interventions, in-person healthcare visits with IDC and other specialists, language spoken, the distance of home residence from the hospital, in-home services used (Early Intervention, Physical Therapy, Occupational therapy, speech).

Nutritional measures: The study team will obtain the child's weight, length, and head circumference at birth and enrollment from the electronic medical record. The investigators will also obtain the following from the electronic medical record: weight for age and z-scores calculated by gender, weight percentiles, length/weight, mid-upper arm circumference (MUAC,) and head circumference. The investigators will use the CHAMP App to track weight at weekly intervals and obtain via parental report. There will be a weekly review, as well as on an as-needed basis, if sooner than weekly, by the IDC's research team, providers and nutrition team.

Healthcare team measures: The IDC team's periods of nutrition interventions will be evaluated for frequency of communication, including feeding interventions with families, volume changes, feeding routes, concentrations, and weight reporting frequency charted in the EMR. The time to first visit with the clinical team after referral to the IDC team, the rate of cancellation/no-show visits, and the number of patients on the wait list for enrollment in the clinical program will also be collected.

Family experience measures: Rate of first patient appointment attended, rate of attrition though never seen, cancellation and no-show appointments, time to first appointment after confirmation of visit in the calendar system, rate of follow-up frequency, graduation from the program with 100% calories by mouth with age-appropriate weight gain vs. attrition rates. Time to the healthcare recommendation of removal of feeding tube after the use of CHAMP app (by type nasogastric (NG) and gastrostomy - g-tube).

Technology measures by parents: Using the CHAMP App, the study team will track parent reported feeding volumes by mouth and tube, weights from home scales, videos of eating, and time to all feedings by mouth.

Technology adherence measures: The study team will track parent use of the app through tracking data on 1) app initiation, the first day of data transfer of CHAMP App data after enrollment; 2) implementation, the amount and type (feeding volumes, type, concentration, food amount, types, and weights) of asynchronous remote patient monitoring data received at the recommended intervals; and 3) discontinuation, the time of last data sent to the healthcare team.

Eligibility criteria: Eligibility Criteria: Parent/LAR-Child dyad was referred for feeding difficulty and tube feeding care at Children's Mercy.

* Inclusion Criteria

  * The child is between the ages of 1 month and five years 11 months.
  * Child is approved for a trial of tube weaning by the managing providers of their feeding difficulty.
* Exclusion Criteria

  * Children who do not meet the criteria to begin tube weaning.
  * Children who are older than 6 years of age at time of enrollment.
  * Parent/LAR of parent/LAR-child dyad who do not speak one of the languages offered via the CHAMP application (English, Spanish, German, Chinese, Vietnamese, Arabic, Korean, French, Filipino, Burmese or Somali).

Primary outcomes:
measure: Adherence Initiation
timeFrame: Time in days, one event- the first day of data transfer of CHAMP App data after enrollment
measure: Adherence Implementation
timeFrame: From enrollment to study endpoint, an average of 6 weeks
measure: Adherence Discontinuation
timeFrame: From enrollment to study endpoint, an average of 6 weeks
measure: Success rate to tube weaning
timeFrame: From enrollment to study endpoint, an average of 6 weeks
measure: Time to weaning
timeFrame: From enrollment to study endpoint, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Lori Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References: