- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06645639
Implementation of P-INPAC (P-INPAC)
Towards Implementation of the Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC) - Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Ste-Justine UHC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
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:
- ≥ 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
Phase 1 & Phase 3 Detailed patient group inclusion Criteria:
- 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
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:
- Implied consent to participate by completing the KAP questionnaire
- Providing clinical service for the select ward
Study Plan
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:
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:
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)
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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)
|
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Baseline nutrition risk screening using weight
Time Frame: 2-month period (phase 1)
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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)
|
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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
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2-month period (phase 1)
|
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Determine baseline knowledge among healthcare providers using the KAP questionnaire
Time Frame: 2-month period (phase 1)
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Determine baseline knowledge among healthcare providers on recognizing malnutrition and its management in hospitalized children, including perceived barriers and practices, using the KAP questionnaire
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2-month period (phase 1)
|
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Determine changes in knowledge among healthcare providers using the KAP questionnaire
Time Frame: 4-month period (phase 3)
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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
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4-month period (phase 3)
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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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000079853
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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