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More-2-Eat Phase 2: Scaling and Spread of the Integrated Nutrition Pathway for Acute Care

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ClinicalTrials.gov Identifier: NCT03391752
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
Canadian Malnutrition Task Force
Canadian Frailty Network
Information provided by (Responsible Party):
Heather Keller, University of Waterloo

Brief 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.

Condition or disease Intervention/treatment
Malnutrition Combination Product: Integrated Nutrition Pathway for Acute Care

Detailed 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.

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Study Type : Observational
Actual Enrollment : 5158 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: More-2-Eat Phase 2: Spread/Scaling up Improved Nutrition Care to Detect and Treat Hospital Malnutrition.
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Royal Alexandria
Administrative records
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

Pasqua Regional hospital
Administrative records
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

Concordia Hospital
Administrative records
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

Niagara General Hospital
Administrative records
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

Hospital 6
Administrative Records
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

Hospital 7
Administrative Records
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

Hospital 8
Administrative Records
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

Hospital 9
Administrative Records
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

Hospital 10
Administrative records
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




Primary Outcome Measures :
  1. success with implementation [ Time Frame: 19 months ]
    rates of screening, diagnosis and treatment with medication pass per month of the study


Secondary Outcome Measures :
  1. Adverse events while in hospital (fall, new infection etc.) [ Time Frame: 19 months ]
  2. Length of stay [ Time Frame: 19 months ]
    Average length of stay for patients admitted to the study unit; monthly average

  3. Readmission rate [ Time Frame: 19 months ]
    number of patients per month discharged and readmitted to the hospital within 30 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients admitted to study units in one of the 10 hospitals included will be subject to the improved nutrition care processes; those that are malnourished will be offered a variety of treatments including medication pass
Criteria

Inclusion Criteria:

  • Patient on the study unit

Exclusion Criteria:

  • patients not on the study unit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391752


Locations
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Canada, Alberta
Royal Alexander Hospital
Edmonton, Alberta, Canada
Canada, Manitoba
Brandon Regional Health Centre
Brandon, Manitoba, Canada
Concordia Hospital
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Victoria General Hospital
Halifax, Nova Scotia, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Lennox Addington County General Hospital
Napanee, Ontario, Canada
Niagara Health Systems
Niagara Falls, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Canada, Saskatchewan
Pasqua Hospital
Regina, Saskatchewan, Canada
Sponsors and Collaborators
University of Waterloo
Canadian Malnutrition Task Force
Canadian Frailty Network
Investigators
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Principal Investigator: Heather Keller, PhD University of Waterloo
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Responsible Party: Heather Keller, Schlegel-University of Waterloo Research Chair, Nutrition & Aging, University of Waterloo
ClinicalTrials.gov Identifier: NCT03391752    
Other Study ID Numbers: KT2017-01
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: UWSpace at the University of Waterloo
Supporting Materials: Analytic Code
Time Frame: 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heather Keller, University of Waterloo:
malnutrition, screening, assessment, treatment
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders