MalnutritionNCT03391752
More-2-Eat Phase 2: Scaling and Spread of the Integrated Nutrition Pathway for Acute Care
An observational study of Malnutrition, run by University of Waterloo at 9 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Integrated Nutrition Pathway for Acute Care
- Type of treatment
- Pill or oral medicine
- How many people
- 5,158 participants
- Where
- 9 sitesCanada
- Study dates
- 1 May 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patient on the study unit
Who cannot join
- patients not on the study unit
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Brandon Regional Health Centre
Brandon, Manitoba
Royal Alexander Hospital
Edmonton, Alberta
Victoria General Hospital
Halifax, Nova Scotia
London Health Sciences Centre
London, Ontario
Lennox Addington County General Hospital
Napanee, Ontario
Niagara Health Systems
Niagara Falls, Ontario
Pasqua Hospital
Regina, Saskatchewan
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Concordia Hospital
Winnipeg, Manitoba
About this study
Official title: More-2-Eat Phase 2: Spread/Scaling up Improved Nutrition Care to Detect and Treat Hospital Malnutrition.
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Integrated Nutrition Pathway for Acute Care
- Keywords
- malnutrition, screening, assessment, treatment
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Nutrition Pathway for Acute CareCombination product
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 group | Role | What they receive |
|---|---|---|
| Royal Alexandria | Administrative records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Pasqua Regional hospital | Administrative records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Concordia Hospital | Administrative records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Niagara General Hospital | Administrative records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Hospital 6 | Administrative Records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Hospital 7 | Administrative Records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Hospital 8 | Administrative Records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Hospital 9 | Administrative Records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care | |
| Hospital 10 | Administrative records Receives: Combination Product: Integrated Nutrition Pathway for Acute Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
success with implementation
rates of screening, diagnosis and treatment with medication pass per month of the study
Measured: 19 months
Secondary outcomes (3)
Adverse events while in hospital (fall, new infection etc.)
Measured: 19 months
Length of stay
Average length of stay for patients admitted to the study unit; monthly average
Measured: 19 months
Readmission rate
number of patients per month discharged and readmitted to the hospital within 30 days
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 May 2018
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Malnutrition Task Force, Canadian Frailty Network
- Responsible party
- Principal investigator, Heather Keller, University of Waterloo
- Investigators
- Heather Keller, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391752
- Sponsor's protocol ID
- KT2017-01
- Status last verified
- Feb 2020
- First submitted
- 1 Jan 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: UWSpace at the University of Waterloo
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.
PubMed 35028514
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More-2-Eat Phase 2: Spread/Scaling up Improved Nutrition Care to Detect and Treat Hospital Malnutrition.
- ClinicalTrials.gov ID
- NCT03391752
- Acronym / sponsor ID
- KT2017-01
- Conditions
- Malnutrition
- Keywords
- malnutrition, screening, assessment, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,158 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Malnutrition Task Force, Canadian Frailty Network
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Royal Alexandria | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative records |
| Pasqua Regional hospital | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative records |
| Concordia Hospital | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative records |
| Niagara General Hospital | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative records |
| Hospital 6 | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative Records |
| Hospital 7 | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative Records |
| Hospital 8 | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative Records |
| Hospital 9 | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative Records |
| Hospital 10 | – | Combination Product: Integrated Nutrition Pathway for Acute CareAdministrative records |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patient on the study unit
Key exclusion criteria (1 listed)
- patients not on the study unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Nutrition Pathway for Acute Carealgorithm 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 | Combination product | Concordia Hospital, Hospital 10, Hospital 6, Hospital 7, Hospital 8, Hospital 9, Niagara General Hospital, Pasqua Regional hospital, Royal Alexandria |
Primary outcome
success with implementation
Time frame: 19 months
rates of screening, diagnosis and treatment with medication pass per month of the study
3 secondary outcomes
Adverse events while in hospital (fall, new infection etc.)
Time frame: 19 months
Length of stay
Time frame: 19 months
Readmission rate
Time frame: 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 35028514Laur 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.
- Individual participant dataSharing planned: Yes. UWSpace at the University of Waterloo
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Keller, PhD principal investigator
University of Waterloo
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University of Waterloo at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success with implementation (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.