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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Heather Keller, PhD; University of Waterloo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Laur C, Bell J, Valaitis R, Ray S, Keller H. The role of trained champions in sustaining and spreading nutrition care improvements in hospital: qualitative interviews following an implementation study. BMJ Nutr Prev Health. 2021 Sep 28;4(2):435-446. doi: 10.1136/bmjnph-2021-000281. eCollection 2021.

• 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
• 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

• 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:

Malnutrition; Nutrition Disorders