NCT06645639

Brief Summary

The framework for Pediatric Integrated Nutrition Pathway for Acute Care (P-INPAC) was developed by the Canadian Malnutrition Task Force (CMTF); however, it has not been implemented in a research setting. The framework by CMTF for Integrated Nutrition Pathway for Acute Care (INPAC) in adults was also implemented in the "More-2-Eat" project which led to development of best practices in nutritional culture of the hospitals. Therefore, we intend to undertake this feasibility project at 3-sites to train staff and evaluate the implementation of P-INPAC components as part of routine healthcare procedure.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 24, 2024

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (10)

  • Baseline nutrition risk screening using STRONGkids or PNST

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using a validated tool, such as, STRONGkids or PNST.

    2-month period (phase 1)

  • Baseline nutrition risk screening using weight

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using routine anthropometrics - weight

    2-month period (phase 1)

  • Baseline nutrition risk screening using height or length

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using routine anthropometrics - height or length in children under 2 years of age

    2-month period (phase 1)

  • Baseline nutrition risk screening using head circumference

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using routine anthropometrics - head circumference in children under 2 years of age

    2-month period (phase 1)

  • Determine baseline knowledge among healthcare providers using the KAP questionnaire

    Determine baseline knowledge among healthcare providers on recognizing malnutrition and its management in hospitalized children, including perceived barriers and practices, using the KAP questionnaire

    2-month period (phase 1)

  • Determine changes in knowledge among healthcare providers using the KAP questionnaire

    Determine changes in knowledge among healthcare providers on recognizing malnutrition and its management in hospitalized children in Phase 3, including perceived barriers and practices, using the KAP questionnaire after training was completed in phase 2

    4-month period (phase 3)

  • Determine success with training and feasibility of nutrition risk screening in hospitalized children using STRONGkids and PNST

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using a validated tool, such as, STRONGkids and PNST

    4-month period (phase 3)

  • Determine success with training and feasibility of nutrition risk screening in hospitalized children using weight

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using routine anthropometrics - weight

    4-month period (phase 3)

  • Determine success with training and feasibility of nutrition risk screening in hospitalized children using height/ length

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using routine anthropometrics - height or length in children under 2 years of age

    4-month period (phase 3)

  • Determine success with training and feasibility of nutrition risk screening in hospitalized children using head circumference

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using routine anthropometrics - head circumference in children under 2 years of age

    4-month period (phase 3)

Study Arms (3)

Audit Group

We will perform an audit of health records of all hospitalized patients at one selected study ward, one day of every other week, at each of the 3 study sites to track their routine nutrition care in phase 1 and changes in nutrition care post-implementation in phase 3.

Other: Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)

Detailed Patient Group

Patients will be recruited in this group from one selected study ward, one day of every other week, at each of the 3 study sites to track their routine nutrition care in phase 1 and changes in nutrition care post-implementation in phase 3. They will also be followed up over a phone call one month after discharge.

Other: Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)

Healthcare Provider Group

A questionnaire assessing the knowledge, attitude, and self-perceived practices (KAP) amongst healthcare professionals will be conducted with staff, including trainees, at each site's study ward. Further, the workload of the study ward's Registered Dietitian will be assessed for 3 days.

Interventions

The pediatric working group of Canadian Malnutrition Task Force has developed an evidence-informed algorithm named the Pediatric Integrated Nutrition Pathway for Acute Care (P-INPAC). The P-INPAC outlines a process to improve nutrition care by: 1. implementing nutrition screening at point-of-admission 2. introducing standard care measures to prevent the development of malnutrition in children admitted with normal nutrition status, including standardizing the process of monitoring food intake early and systematically to identify when standard care measures are not sufficient 3. ensuring the moderately and severely malnourished patients receive timely specialized care in the form of a comprehensive assessment and treatment; and 4. ensuring moderately and severely malnourished patients receive adequate post discharge follow-up and nutrition care. In this pilot study, we will be implementing the first two steps of P-INPAC only (screening and assessment).

Audit GroupDetailed Patient Group

Eligibility Criteria

Age30 Days - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

2 Patient Groups (Audit and Detailed) 1 Health care providers group comprising of all the healthcare providers on the participating wards.

You may qualify if:

  • ≥ 30 days of age and less than18 years of age on day of assessment
  • Anticipated Length of hospital stay ≥24 hours from day of assessment
  • Admitted to either a general medical or surgical ward
  • ≥ 30 days of age and less than 18 years of age on day of assessment
  • Anticipated Length of stay ≥ 24 hours from day of assessment
  • Speak English (or French at Quebec site) or have a family proxy available at the meal to provide information if first language of patient is not English (or French at Quebec site)
  • Patient/ caregiver provides written consent to participate

You may not qualify if:

  • a. Patients with eating disorder, somatization disorders, ARFID, FORM 1 etc. where the study interaction might interfere with the messaging or therapeutic plan as set out by the responsible team.
  • Implied consent to participate by completing the KAP questionnaire
  • Providing clinical service for the select ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Ste-Justine UHC

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Related Publications (4)

  • Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.

    PMID: 19682776BACKGROUND
  • Secker DJ, Jeejeebhoy KN. How to perform Subjective Global Nutritional assessment in children. J Acad Nutr Diet. 2012 Mar;112(3):424-431.e6. doi: 10.1016/j.jada.2011.08.039. Epub 2012 Mar 1.

    PMID: 22717202BACKGROUND
  • Huysentruyt K, Brunet-Wood K, Bandsma R, Gramlich L, Fleming-Carroll B, Hotson B, Byers R, Lovelace H, Persad R, Kalnins D, Martinez A, Marchand V, Vachon M, Hulst JM, On Behalf Of The Canadian Malnutrition Task Force-Pediatric Working Group. Canadian Nationwide Survey on Pediatric Malnutrition Management in Tertiary Hospitals. Nutrients. 2021 Jul 30;13(8):2635. doi: 10.3390/nu13082635.

    PMID: 34444796BACKGROUND
  • Keller H, Laur C, Atkins M, Bernier P, Butterworth D, Davidson B, Hotson B, Nasser R, Laporte M, Marcell C, Ray S, Bell J. Update on the Integrated Nutrition Pathway for Acute Care (INPAC): post implementation tailoring and toolkit to support practice improvements. Nutr J. 2018 Jan 5;17(1):2. doi: 10.1186/s12937-017-0310-1.

    PMID: 29304866BACKGROUND

Related Links

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Jessie Hulst

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

July 24, 2024

First Posted

October 17, 2024

Study Start

September 4, 2023

Primary Completion

February 28, 2025

Study Completion

December 1, 2025

Last Updated

October 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

The data entered the REDCap data collection form will be completely confidential and de-identified and can only be rendered identifiable by linking the study IDs in the data collection form to the study IDs encrypted master linking log. The master linking log will be maintained by the site and not shared by the other site. Confidentiality will be respected and no information that discloses the identity of the participants will be released or published. The data will be kept stored for a minimum of 7 years following collection of the study in accordance with SickKids data retention policy, or longer as per study site institutional research ethics board requirements.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be kept stored for a minimum of 7 years following collection of the study in accordance with SickKids data retention policy, or longer as per study site institutional research ethics board requirements.
Access Criteria
Research team members

Locations