We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 1, 2018
First Posted Date January 5, 2018
Last Update Posted Date February 11, 2020
Actual Study Start Date May 1, 2018
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 5, 2018)
success with implementation [ Time Frame: 19 months ]
rates of screening, diagnosis and treatment with medication pass per month of the study
Original Primary Outcome Measures
 (submitted: January 1, 2018)
  • success with implementation [ Time Frame: 19 months ]
    rates of screening, diagnosis and treatment with medication pass
  • Length of stay [ Time Frame: 19 monts ]
  • Readmission rate [ Time Frame: 19 months ]
Change History
Current Secondary Outcome Measures
 (submitted: January 5, 2018)
  • Adverse events while in hospital (fall, new infection etc.) [ Time Frame: 19 months ]
  • Length of stay [ Time Frame: 19 months ]
    Average length of stay for patients admitted to the study unit; monthly average
  • Readmission rate [ Time Frame: 19 months ]
    number of patients per month discharged and readmitted to the hospital within 30 days
Original Secondary Outcome Measures
 (submitted: January 1, 2018)
Adverse events while in hospital (fall, new infection etc.) [ Time Frame: 19 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title More-2-Eat Phase 2: Scaling and Spread of the Integrated Nutrition Pathway for Acute Care
Official Title More-2-Eat Phase 2: Spread/Scaling up Improved Nutrition Care to Detect and Treat Hospital Malnutrition.
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Malnutrition
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
Study Groups/Cohorts
  • Royal Alexandria
    Administrative records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Pasqua Regional hospital
    Administrative records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Concordia Hospital
    Administrative records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Niagara General Hospital
    Administrative records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Hospital 6
    Administrative Records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Hospital 7
    Administrative Records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Hospital 8
    Administrative Records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Hospital 9
    Administrative Records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
  • Hospital 10
    Administrative records
    Intervention: Combination Product: Integrated Nutrition Pathway for Acute Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2020)
5158
Original Estimated Enrollment
 (submitted: January 1, 2018)
4000
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient on the study unit

Exclusion Criteria:

  • patients not on the study unit
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03391752
Other Study ID Numbers KT2017-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: UWSpace at the University of Waterloo
Supporting Materials: Analytic Code
Time Frame: 2020
Current Responsible Party Heather Keller, University of Waterloo
Original Responsible Party Same as current
Current Study Sponsor University of Waterloo
Original Study Sponsor Same as current
Collaborators
  • Canadian Malnutrition Task Force
  • Canadian Frailty Network
Investigators
Principal Investigator: Heather Keller, PhD University of Waterloo
PRS Account University of Waterloo
Verification Date February 2020