Implementation of P-INPAC (P-INPAC)

June 19, 2026 updated by: Jessie Hulst, The Hospital for Sick Children

Towards Implementation of the Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC) - Pilot Study

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.

Study Overview

Detailed Description

The P-INPAC pilot study will be a 3-phase multi-center research study in hospitalized children, conducted at The Hospital for Sick Children, Toronto, and two other Canadian pediatric centres: Centre hospitalier universitaire Sainte-Justine, Montreal, Quebec and McMaster Children's Hospital, Hamilton, Ontario. P-INPAC is an algorithm which helps to identify, assess, and treat children with malnutrition.

In the first phase of the study, we will perform an audit of health records of all hospitalized patients at one selected study ward, one day of every other week for 8 weeks, at each of the 3 study sites to track their routine nutrition care. We anticipate auditing 80-100 patients/site in this cycle (total 240-300 patients). In addition, ≈12- 20 patients/ site (≈ 60 in total) who consent to detailed malnutrition screening and assessment would also be identified, assessed, and followed up one month after discharge. In addition, a questionnaire assessing the malnutrition 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 (RD) will be assessed for 3 days.

In the second phase of the study, the health care team from each site's study ward will be trained by the site implementation research team about the P-INPAC, and how to administer nutritional screening and perform nutritional assessments, which is the Subjective Global Nutrition Assessment (SGNA).

Finally, in the third phase, we will monitor and evaluate the implementation of the first 2 steps of the P-INPAC (screening & assessment) over a period of 4 months assessing the acceptability, adoption, and coverage of improved nutrition care practices on the same pediatric study wards. We anticipate auditing 160-200 patients/site in this cycle (total 480-600 patients). In addition, detailed patient level data collection will take place in a selected group of consented patients, ≈24-40 patients per site from the 3 sites (≈120 in total). We would also follow-up with these patients a month after discharge.

Healthcare providers will be invited to answer the KAP questionnaire post-implementation version. We will compare responses from phase 1 with phase 3 (pre-/ post-follow up). And, the workload of the ward RD will be assessed again over 3 days.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Ste-Justine UHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Phase 1 and Phase 3 - Audited patient group inclusion Criteria:

  1. ≥ 30 days of age and less than18 years of age on day of assessment
  2. Anticipated Length of hospital stay ≥24 hours from day of assessment

Phase 1 & Phase 3 Detailed patient group inclusion Criteria:

  1. Admitted to either a general medical or surgical ward
  2. ≥ 30 days of age and less than 18 years of age on day of assessment
  3. Anticipated Length of stay ≥ 24 hours from day of assessment
  4. 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)
  5. Patient/ caregiver provides written consent to participate

Exclusion Criteria:

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.

Phase 1 and 3 for Health Care Providers inclusion criteria:

  1. Implied consent to participate by completing the KAP questionnaire
  2. Providing clinical service for the select ward

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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).

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.

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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline nutrition risk screening using STRONGkids or PNST
Time Frame: 2-month period (phase 1)
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
Time Frame: 2-month period (phase 1)
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
Time Frame: 2-month period (phase 1)
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
Time Frame: 2-month period (phase 1)
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
Time Frame: 2-month period (phase 1)
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
Time Frame: 4-month period (phase 3)
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
Time Frame: 4-month period (phase 3)
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
Time Frame: 4-month period (phase 3)
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
Time Frame: 4-month period (phase 3)
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
Time Frame: 4-month period (phase 3)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1000079853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Research team members

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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