More-2-Eat Phase 2: Scaling and Spread of the Integrated Nutrition Pathway for Acute Care
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| ClinicalTrials.gov Identifier: NCT03391752 |
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Recruitment Status :
Completed
First Posted : January 5, 2018
Last Update Posted : February 11, 2020
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| Tracking Information | |||||||||
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| 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 |
success with implementation [ Time Frame: 19 months ] rates of screening, diagnosis and treatment with medication pass per month of the study
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| 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
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| Study Groups/Cohorts |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Completed | ||||||||
| Actual Enrollment |
5158 | ||||||||
| Original Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT03391752 | ||||||||
| Other Study ID Numbers | KT2017-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| 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 |
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| Investigators |
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| PRS Account | University of Waterloo | ||||||||
| Verification Date | February 2020 | ||||||||