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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03391752
Other study ID # KT2017-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

More-2-Eat Phase 2 provides the opportunity to extend the implementation of the Integrated Nutrition Pathway to a total of 10 hospitals and more than 20 medical/surgical units. Building on the success of More-2-Eat Phase 1, key components of this implementation study will be a registry for self-managed data entry and reports and a community of practice to support implementation of nutrition screening at admission to hospital, subjective global assessment to diagnose and triage patients to care pathways and medication pass of a small amount of nutrient dense oral nutritional supplement. Success with implementation and impact on key patient outcomes will be determined.


Description:

Malnutrition in hospital patients is a growing problem, with 20-45% of patients already malnourished at admission. As 70% of malnourished patients are also frail, early detection and treatment of malnutrition is one way to improve the outcomes of frail older adults. To improve the detection and treatment of these conditions, the PI developed the Integrated Nutrition Pathway for Acute Care (INPAC) that guides hospital staff on when to conduct key nutrition care activities to improve outcomes (e.g. screening at admission).

In More-2-Eat (April 2015-March 2017), 5 Canadian hospital units in 4 provinces received funding to implement INPAC. Each hospital, with support from a research team had 1 year to implement INPAC. All 5 hospitals were successful in improving detection and treatment of malnutrition, and started to screen for frailty. Clinical care was transformed in the study units; for example all sites progressed from low baseline or no screening at admission to a rate of 75%. Findings also demonstrate improvement in clinical outcomes such as a shorter length of stay. An online INPAC Implementation Toolkit was developed to promote mobilization of this knowledge. What is not known is whether or not the results can be replicated under normal circumstances (i.e., no external funding for implementation at a hospital site).

To sustain and expand on this success, a Phase 2 knowledge translation project is proposed that will involve the five original Phase 1 sites and five further hospitals as Phase 2 sites. The goal of the second phase is to see if Phase 1 sites can spread success to other units within their hospitals and if Phase 2 sites can achieve similar results across a broader group of patients.

The end product will be a sustainable model including a community of practice supported by our partner the Canadian Malnutrition Task Force, and a self-serve registry that allows sites to collect and report data to change their practice. Investigators will also confirm capacity of INPAC activities to improve clinical outcomes across diverse settings. This knowledge translation and implementation study will demonstrate the potential to transform clinical nutrition care, benefiting all pre-frail and frail older adults.


Recruitment information / eligibility

Status Completed
Enrollment 5158
Est. completion date December 31, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient on the study unit

Exclusion Criteria:

- patients not on the study unit

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Integrated Nutrition Pathway for Acute Care
algorithm to guide care processes with respect to nutrition e.g. screening on admission, diagnosis with subjective global assessment, early treatment with medication pass of oral nutritional supplement

Locations

Country Name City State
Canada Brandon Regional Health Centre Brandon Manitoba
Canada Royal Alexander Hospital Edmonton Alberta
Canada Victoria General Hospital Halifax Nova Scotia
Canada London Health Sciences Centre London Ontario
Canada Lennox Addington County General Hospital Napanee Ontario
Canada Niagara Health Systems Niagara Falls Ontario
Canada Pasqua Hospital Regina Saskatchewan
Canada Thunder Bay Regional Health Sciences Centre Thunder Bay Ontario
Canada Concordia Hospital Winnipeg Manitoba

Sponsors (3)

Lead Sponsor Collaborator
University of Waterloo Canadian Frailty Network, Canadian Malnutrition Task Force

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary success with implementation rates of screening, diagnosis and treatment with medication pass per month of the study 19 months
Secondary Adverse events while in hospital (fall, new infection etc.) 19 months
Secondary Length of stay Average length of stay for patients admitted to the study unit; monthly average 19 months
Secondary Readmission rate number of patients per month discharged and readmitted to the hospital within 30 days 19 months
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