MalnutritionNCT02277535
An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU
A study testing Feedback/Reminder email. in people with Malnutrition, run by Massachusetts General Hospital.
Trial summary
This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Feedback/Reminder email.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Apr 2015
- Phase
- Interventional
- 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
Who may be able to join
- Clinicians taking care of patients admitted to the ICU within the past 48hrs
- Clinicians taking care of patients in whom enteral nutrition is prescribed
Who cannot join
- Clinicians taking care of patients in whom enteral nutrition is not prescribed.
About this study
This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU.
Read the detailed description
This prospective study looks to determine if a targeted email to clinicians taking care of critically ill patients will allow reduce malnutrition in the Intensive Care Units (ICU). Four ICUs will be included: medical ICU (MICU), coronary care unit (CCU) and two surgical ICUs. The investigators will rotate a 2 month period intervention amongst the aforementioned participating ICUs and follow simultaneous cohorts to evaluate the effect of our intervention (email feedback to treating clinicians) on nutrition delivery in the ICU. After the completion of the intervention, there will be a six-month follow-up of nutritional adequacy to assess the durability of changes in behavior.
- Conditions
- Malnutrition
- Being tested
- Feedback/Reminder email.
- Keywords
- Malnutrition in the ICU (caloric deficit >4000 kcal or 150 g protein deficit) or >48hrs of admission without receiving nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback/Reminder email.Other
| Study group | Role | What they receive |
|---|---|---|
| E-mail intervention | Experimental | ICU clinicians caring for patients who have not yet been initiated on nutrition 48 hours after ICU admission will receive a reminder email.
ICU clinicians caring for patients who accumulate a caloric deficit greater than 4000 calories or 150 g protein deficit will receive a feedback email Receives: Other: Feedback/Reminder email. |
| No E-mail intervention | No intervention | Nutrition status of patients will be assessed but no reminder or feedback emails will be sent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients started on nutrition within 72 h of ICU admission
The ICU admission date and EN initiation date will be collected in a data base which will later be analyzed to assess the percentange of patients initiated on EN within 72 hours of admission to the ICU. This will be reported as rates and will be compared amongst intervention and no-intervention arms using Fisher's Exact test or Chi-sq Test
Measured: After completing the intervention for each ICU (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Dante Yeh, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277535
- Sponsor's protocol ID
- 2014P001702
- Status last verified
- Jan 2017
- First submitted
- 27 Oct 2014
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU
- ClinicalTrials.gov ID
- NCT02277535
- Acronym / sponsor ID
- 2014P001702
- Conditions
- Malnutrition
- Keywords
- Malnutrition in the ICU (caloric deficit >4000 kcal or 150 g protein deficit) or >48hrs of admission without receiving nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Oct 2014 (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.
This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU.
Detailed description
This prospective study looks to determine if a targeted email to clinicians taking care of critically ill patients will allow reduce malnutrition in the Intensive Care Units (ICU). Four ICUs will be included: medical ICU (MICU), coronary care unit (CCU) and two surgical ICUs. The investigators will rotate a 2 month period intervention amongst the aforementioned participating ICUs and follow simultaneous cohorts to evaluate the effect of our intervention (email feedback to treating clinicians) on nutrition delivery in the ICU. After the completion of the intervention, there will be a six-month follow-up of nutritional adequacy to assess the durability of changes in behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-mail intervention | Experimental | Other: Feedback/Reminder email.ICU clinicians caring for patients who have not yet been initiated on nutrition 48 hours after ICU admission will receive a reminder email. ICU clinicians caring for patients who accumulate a caloric deficit greater than 4000 calories or 150 g protein deficit will receive a feedback email |
| No E-mail intervention | No intervention | –Nutrition status of patients will be assessed but no reminder or feedback emails will be sent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinicians taking care of patients admitted to the ICU within the past 48hrs
- Clinicians taking care of patients in whom enteral nutrition is prescribed
Key exclusion criteria (1 listed)
- Clinicians taking care of patients in whom enteral nutrition is not prescribed.
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 |
|---|---|---|
| Feedback/Reminder email. | Other | E-mail intervention |
Primary outcome
Patients started on nutrition within 72 h of ICU admission
Time frame: After completing the intervention for each ICU (2 months)
The ICU admission date and EN initiation date will be collected in a data base which will later be analyzed to assess the percentange of patients initiated on EN within 72 hours of admission to the ICU. This will be reported as rates and will be compared amongst intervention and no-intervention arms using Fisher's Exact test or Chi-sq Test
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 2 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback/Reminder email. in people with Malnutrition, run by Massachusetts General Hospital.
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 2 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Patients started on nutrition within 72 h of ICU admission (time frame: After completing the intervention for each ICU (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2017.