Clinical trial NCT06645639: Implementation of P-INPAC
Official title: Towards Implementation of the Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC) - Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition, Child
Nutrition Poor
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: McMaster Children's Hospital
name: St. Justine's Hospital
First posted: 2024-10-17
Enrollment: 600
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline nutrition risk screening using STRONGkids or PNST
timeFrame: 2-month period (phase 1)
measure: Baseline nutrition risk screening using weight
timeFrame: 2-month period (phase 1)
measure: Baseline nutrition risk screening using height or length
timeFrame: 2-month period (phase 1)
measure: Baseline nutrition risk screening using head circumference
timeFrame: 2-month period (phase 1)
measure: Determine baseline knowledge among healthcare providers using the KAP questionnaire
timeFrame: 2-month period (phase 1)
measure: Determine changes in knowledge among healthcare providers using the KAP questionnaire
timeFrame: 4-month period (phase 3)
measure: Determine success with training and feasibility of nutrition risk screening in hospitalized children using STRONGkids and PNST
timeFrame: 4-month period (phase 3)
measure: Determine success with training and feasibility of nutrition risk screening in hospitalized children using weight
timeFrame: 4-month period (phase 3)
measure: Determine success with training and feasibility of nutrition risk screening in hospitalized children using height/ length
timeFrame: 4-month period (phase 3)
measure: Determine success with training and feasibility of nutrition risk screening in hospitalized children using head circumference
timeFrame: 4-month period (phase 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: Ste-Justine UHC
state: Quebec
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.