Acute Care Medicalm2ENCT02800304
More-2-Eat; Implementation of INPAC
An observational study of Acute Care Medical, run by University of Waterloo at 5 sites in Canada.
Trial summary
M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway for Acute Care, in five medical units in five hospitals in Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Care Medical
- How many people
- 5,995 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Sep 2015to 31 Mar 2017
- 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: medical patients over the age of 18 years
Who may be able to join
- admitted to study unit
- no delirium or dementia
- return to community anticipated
Who cannot join
- unable to communicate in English or French
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Royal Alexander Hospital
Edmonton, Alberta
Niagara Health Systems
Niagara Falls, Ontario
The Ottawa Hospital
Ottawa, Ontario
Pasqua Hospital
Regina, Saskatchewan
Concordia Hospital
Winnipeg, Manitoba
About this study
M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway for Acute Care, in five medical units in five hospitals in Canada.
- Conditions
- Acute Care Medical
- Keywords
- malnutrition, food intake, frailty
- Medical subject headings
- Malnutrition, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation success of Integrated Nutrition Pathway for Acute Care (INPAC)
INPAC is an evidence based pathway to improve detection, prevention and treatment of malnutrition in acute care. The primary outcome of this study is the trajectory and proportion of care activities that happen for a given population e.g. % screened, assessed with SGA, have standard care strategies provided etc.
Measured: admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start1 Sep 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Care MedicalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,995 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- 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
- NCT02800304
- Sponsor's protocol ID
- 20590
- Acronym
- m2E
- Status last verified
- Feb 2019
- First submitted
- 7 Jun 2016
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 35028514Valaitis R, Laur C, Keller H, Butterworth D, Hotson B. Need for the Integrated Nutrition Pathway for Acute Care (INPAC): gaps in current nutrition care in five Canadian hospitals. BMC Nutr. 2017 Jul 14;3:60. doi: 10.1186/s40795-017-0177-8. eCollection 2017.
PubMed 32153840Laur C, Bell J, Valaitis R, Ray S, Keller H. The Sustain and Spread Framework: strategies for sustaining and spreading nutrition care improvements in acute care based on thematic analysis from the More-2-Eat study. BMC Health Serv Res. 2018 Dec 4;18(1):930. doi: 10.1186/s12913-018-3748-8.
PubMed 30509262Keller HH, Xu Y, Dubin JA, Curtis L, Laur CV, Bell J; More-2-Eat Team. Improving the standard of nutrition care in hospital: Mealtime barriers reduced with implementation of the Integrated Nutrition Pathway for Acute Care. Clin Nutr ESPEN. 2018 Dec;28:74-79. doi: 10.1016/j.clnesp.2018.09.075. Epub 2018 Oct 11.
PubMed 30390896Keller HH, Valaitis R, Laur CV, McNicholl T, Xu Y, Dubin JA, Curtis L, Obiorah S, Ray S, Bernier P, Gramlich L, Stickles-White M, Laporte M, Bell J. Multi-site implementation of nutrition screening and diagnosis in medical care units: Success of the More-2-Eat project. Clin Nutr. 2019 Apr;38(2):897-905. doi: 10.1016/j.clnu.2018.02.009. Epub 2018 Mar 22.
PubMed 29605573Laur C, Valaitis R, Bell J, Keller H. Changing nutrition care practices in hospital: a thematic analysis of hospital staff perspectives. BMC Health Serv Res. 2017 Jul 19;17(1):498. doi: 10.1186/s12913-017-2409-7.
PubMed 28724373
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More-2-Eat; Implementation of INPAC
- ClinicalTrials.gov ID
- NCT02800304
- Acronym / sponsor ID
- m2E / 20590
- Conditions
- Acute Care Medical
- Keywords
- malnutrition, food intake, frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,995 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- 1 Sep 2015
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway for Acute Care, in five medical units in five hospitals in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- medical patients over the age of 18 years
Key inclusion criteria (3 listed)
- admitted to study unit
- no delirium or dementia
- return to community anticipated
Key exclusion criteria (1 listed)
- unable to communicate in English or French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation success of Integrated Nutrition Pathway for Acute Care (INPAC)
Time frame: admission
INPAC is an evidence based pathway to improve detection, prevention and treatment of malnutrition in acute care. The primary outcome of this study is the trajectory and proportion of care activities that happen for a given population e.g. % screened, assessed with SGA, have standard care strategies provided etc.
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 5 Feb 2019.
- 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.
- Derived from this study: PubMed 32153840Valaitis R, Laur C, Keller H, Butterworth D, Hotson B. Need for the Integrated Nutrition Pathway for Acute Care (INPAC): gaps in current nutrition care in five Canadian hospitals. BMC Nutr. 2017 Jul 14;3:60. doi: 10.1186/s40795-017-0177-8. eCollection 2017.
- Derived from this study: PubMed 30509262Laur C, Bell J, Valaitis R, Ray S, Keller H. The Sustain and Spread Framework: strategies for sustaining and spreading nutrition care improvements in acute care based on thematic analysis from the More-2-Eat study. BMC Health Serv Res. 2018 Dec 4;18(1):930. doi: 10.1186/s12913-018-3748-8.
- Derived from this study: PubMed 30390896Keller HH, Xu Y, Dubin JA, Curtis L, Laur CV, Bell J; More-2-Eat Team. Improving the standard of nutrition care in hospital: Mealtime barriers reduced with implementation of the Integrated Nutrition Pathway for Acute Care. Clin Nutr ESPEN. 2018 Dec;28:74-79. doi: 10.1016/j.clnesp.2018.09.075. Epub 2018 Oct 11.
- Derived from this study: PubMed 29605573Keller HH, Valaitis R, Laur CV, McNicholl T, Xu Y, Dubin JA, Curtis L, Obiorah S, Ray S, Bernier P, Gramlich L, Stickles-White M, Laporte M, Bell J. Multi-site implementation of nutrition screening and diagnosis in medical care units: Success of the More-2-Eat project. Clin Nutr. 2019 Apr;38(2):897-905. doi: 10.1016/j.clnu.2018.02.009. Epub 2018 Mar 22.
- Derived from this study: PubMed 28724373Laur C, Valaitis R, Bell J, Keller H. Changing nutrition care practices in hospital: a thematic analysis of hospital staff perspectives. BMC Health Serv Res. 2017 Jul 19;17(1):498. doi: 10.1186/s12913-017-2409-7.
- Primary analysis on implementation processLink provided by the sponsor.
- Primary analysis on patient outcomes resulting from implementationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Care Medical, run by University of Waterloo at 5 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 3 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Implementation success of Integrated Nutrition Pathway for Acute Care (INPAC) (time frame: admission). 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 NCT02800304, which also lists 6 linked publications.
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 5 Feb 2019.