Critical IllnessIMPACTNCT02920086
Improving Partnerships With Family Members of ICU Patients
A study testing Nutrition Education Program and Decision Support Program in people with Critical Illness, run by Clinical Evaluation Research Unit at Kingston General Hospital at 10 sites in 3 countries.
Trial summary
The purpose of this study is to improve the outcomes of critically ill older patients and the health outcomes of their families by capacitating and partnering with families in optimizing patient/family centered care. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Nutrition Education Program and Decision Support Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 9 May 2017to Dec 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1a) > 60 years of age OR
- 1b) 55 years to 59 years old with one or more of the following diagnoses:
- Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L.
- Congestive heart failure - New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%.
- Cirrhosis - confirmed by imaging studies or documentation of esophageal varices and one of three conditions: a) hepatic coma, b) Child's class C liver disease, or c) Child's class B liver disease with gastrointestinal bleeding.
- Cancer - metastatic cancer or stage IV lymphoma.
Show all 16Show fewer
- End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness) 2) Have a projected duration of ICU dependency of >72 hours from time of final assessment. We define ICU dependency as the need for one or more of the following:
- Mechanical ventilation
- Non-invasive ventilation
- Renal replacement therapy
- Vasopressors or
- Artificial nutrition because of their underlying illness
- 18 years of age or older,
- present and expected to visit regularly (minimum about 3 times a week) while the patient is in hospital
- the nominated or legally appointed substitute decision-maker
- able to communicate in English (verbally and in writing).
Who cannot join
- Patients who are not expected to remain alive in ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)
- Uncomplicated elective surgical patients (regardless of age)
- Patients who have received organ transplantation during this hospitalization
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Lauren Van Scoy
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Jayshil Patel
- Recruiting
Phoenix VA Medical Center
Phoenix, Arizona, 85012
Mary Chew
- Recruiting
Barnes Jewish Hospital/Washington University
St Louis, Missouri, 63110-1093
Beth Taylor
- Recruiting
Legacy Salmon Creek Medical Center
Vancouver, Washington, 98686
Joseph Jura, Dr
Canada4 sites, 2 recruiting
- Withdrawn
University of Calgary
Calgary, Alberta
- Recruiting
University of Ottawa
Ottawa, Ontario
Kwadwo Kyeremanteng
- Recruiting
Sunnybrook Health Science Centre
Toronto, Ontario
Dominique Piquette
- Terminated
University Health Network
Toronto, Ontario
Australia1 site, 1 recruiting
- Recruiting
Gold Coast Health
Gold Coast, Queensland
Andrea Marshall
About this study
Official title: Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
The purpose of this study is to improve the outcomes of critically ill older patients and the health outcomes of their families by capacitating and partnering with families in optimizing patient/family centered care.
Read the detailed description
There is a pressing need to improve the care of critically ill older patients. For critically ill patients who are frequently unable to participate in their own care and decision-making, partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. However, the optimal means by which families engage in the role they play, and how best to capacitate them as advocates and partners in care while helping them maintain their own wellbeing, is not known.
The IMPACT trial will evaluate two interventions, each with a separate context, but similar in that they empower and support families; one focused on involvement in care, and the other focused on involvement in decision-making. The first is a nutrition intervention The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICs) intervention, a multi-faceted strategy to engage and empower family members to advocate for and audit best nutrition practices in their family members. The second is a decision support intervention. The REALISTIC-80 Decision Support Intervention, is a web-based tool (www.myicuguide.com) to support families in shared decision-making about goals of medical treatments.
The investigators propose to conduct a mixed methods multi-centre, open-label, randomized, clinical trial involving 3 groups (2 active interventions and a usual care group). The overall goal of this study is to demonstrate that the multi-faceted nutritional strategies that engage families in care of their family member tested in this trial will increase nutritional intake and optimize physical recovery in older critically ill patients at high nutrition risk.
- Conditions
- Critical Illness
- Being tested
- Nutrition Education Program, Decision Support Program
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education ProgramBehavioural
Also called OPTICS
- The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention
- Nutritional education will be provided to ICU patents' families by a dietitian
- Tracking of nutritional information by family
- Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day)
Decision Support ProgramOther
Also called The REALISTIC-80 Decision Support Intervention, My ICU Guide
- Families will be provided with a web-based decision support tool (My ICU Guide)
- Families will meet with the ICU medical team early in ICU stay to review goals of care
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education Program | Experimental | Nutrition education for family members of an elderly critically ill patient Receives: Behavioral: Nutrition Education Program |
| Decision Support Program | Experimental | Decision support education for family members of an elderly critically ill patient Receives: Other: Decision Support Program |
| Usual Care | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional adequacy during the ICU stay
Measured: Up to 30 days in ICU
Consumption of Oral Nutritional Supplements
Measured: First four weeks once on ward
Intake on hospital wards (3 day calorie count)
Measured: First four weeks once on ward
Hand grip strength
Hydraulic hand dynamometer
Measured: At or before hospital discharge or up to 90 days
Use of shared-decision making (OPTION tool)
Measured: Within first week in ICU
Change in decisional conflict
10-item Decisional Conflict Scale
Measured: 1 week
Family satisfaction with decision-making
Measured: 1 week
Overall family satisfaction with ICU
Measured: At ICU discharge, an average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start9 May 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Griffith University
- Responsible party
- Principal investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren Heyland, MD, Principal investigator, Clinical Evaluation Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920086
- Sponsor's protocol ID
- IMPACT
- Acronym
- IMPACT
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2016
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marshall AP, Van Scoy LJ, Chaboyer W, Chew M, Davidson J, Day AG, Martinez A, Patel J, Roberts S, Skrobik Y, Taylor B, Tobiano G, Heyland DK. A randomised controlled trial of a nutrition and a decision support intervention to enable partnerships with families of critically ill patients. J Clin Nurs. 2023 Sep;32(17-18):6723-6742. doi: 10.1111/jocn.16752. Epub 2023 May 9.
PubMed 37161555Heyland DK, Davidson J, Skrobik Y, des Ordons AR, Van Scoy LJ, Day AG, Vandall-Walker V, Marshall AP. Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):3. doi: 10.1186/s13063-017-2379-4.
PubMed 29301555
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial
- ClinicalTrials.gov ID
- NCT02920086
- Acronym / sponsor ID
- IMPACT / IMPACT
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Griffith University
- Study start
- 9 May 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Sep 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.
The purpose of this study is to improve the outcomes of critically ill older patients and the health outcomes of their families by capacitating and partnering with families in optimizing patient/family centered care.
Detailed description
There is a pressing need to improve the care of critically ill older patients. For critically ill patients who are frequently unable to participate in their own care and decision-making, partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. However, the optimal means by which families engage in the role they play, and how best to capacitate them as advocates and partners in care while helping them maintain their own wellbeing, is not known.
The IMPACT trial will evaluate two interventions, each with a separate context, but similar in that they empower and support families; one focused on involvement in care, and the other focused on involvement in decision-making. The first is a nutrition intervention The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICs) intervention, a multi-faceted strategy to engage and empower family members to advocate for and audit best nutrition practices in their family members. The second is a decision support intervention. The REALISTIC-80 Decision Support Intervention, is a web-based tool (www.myicuguide.com) to support families in shared decision-making about goals of medical treatments.
The investigators propose to conduct a mixed methods multi-centre, open-label, randomized, clinical trial involving 3 groups (2 active interventions and a usual care group). The overall goal of this study is to demonstrate that the multi-faceted nutritional strategies that engage families in care of their family member tested in this trial will increase nutritional intake and optimize physical recovery in older critically ill patients at high nutrition risk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education Program | Experimental | Behavioral: Nutrition Education ProgramNutrition education for family members of an elderly critically ill patient |
| Decision Support Program | Experimental | Other: Decision Support ProgramDecision support education for family members of an elderly critically ill patient |
| Usual Care | No intervention | –No intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1a) > 60 years of age OR
- Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L.
- Congestive heart failure - New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%.
- Cirrhosis - confirmed by imaging studies or documentation of esophageal varices and one of three conditions: a) hepatic coma, b) Child's class C liver disease, or c) Child's class B liver disease with gastrointestinal bleeding.
- Cancer - metastatic cancer or stage IV lymphoma.
Key exclusion criteria (3 listed)
- Patients who are not expected to remain alive in ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)
- Uncomplicated elective surgical patients (regardless of age)
- Patients who have received organ transplantation during this hospitalization
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 |
|---|---|---|
| Nutrition Education ProgramAlso: OPTICS* The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention * Nutritional education will be provided to ICU patents' families by a dietitian * Tracking of nutritional information by family * Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day) | Behavioural | Nutrition Education Program |
| Decision Support ProgramAlso: The REALISTIC-80 Decision Support Intervention, My ICU Guide* Families will be provided with a web-based decision support tool (My ICU Guide) * Families will meet with the ICU medical team early in ICU stay to review goals of care | Other | Decision Support Program |
Primary outcome
Nutritional adequacy during the ICU stay
Time frame: Up to 30 days in ICU
Consumption of Oral Nutritional Supplements
Time frame: First four weeks once on ward
Intake on hospital wards (3 day calorie count)
Time frame: First four weeks once on ward
Hand grip strength
Time frame: At or before hospital discharge or up to 90 days
Hydraulic hand dynamometer
Use of shared-decision making (OPTION tool)
Time frame: Within first week in ICU
Change in decisional conflict
Time frame: 1 week
10-item Decisional Conflict Scale
Family satisfaction with decision-making
Time frame: 1 week
Overall family satisfaction with ICU
Time frame: At ICU discharge, an average of 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 37161555Marshall AP, Van Scoy LJ, Chaboyer W, Chew M, Davidson J, Day AG, Martinez A, Patel J, Roberts S, Skrobik Y, Taylor B, Tobiano G, Heyland DK. A randomised controlled trial of a nutrition and a decision support intervention to enable partnerships with families of critically ill patients. J Clin Nurs. 2023 Sep;32(17-18):6723-6742. doi: 10.1111/jocn.16752. Epub 2023 May 9.
- Derived from this study: PubMed 29301555Heyland DK, Davidson J, Skrobik Y, des Ordons AR, Van Scoy LJ, Day AG, Vandall-Walker V, Marshall AP. Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):3. doi: 10.1186/s13063-017-2379-4.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Daren Heyland, MD principal investigator
Clinical Evaluation Research Unit
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education Program and Decision Support Program in people with Critical Illness, run by Clinical Evaluation Research Unit at Kingston General Hospital at 10 sites in 3 countries.
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 16 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daren Heyland, MD (613-549-6666 ext. 3339, dkh2@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional adequacy during the ICU stay (time frame: Up to 30 days in ICU). The study lists 8 primary outcomes in all. 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 NCT02920086, which also lists 2 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 9 Sep 2019.