Improving Partnerships With Family Members of ICU Patients

Critical Illness Clinical Trial

— IMPACT  

Official title:

Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02920086
• Other study ID #: IMPACT
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Clinical Evaluation Research Unit at Kingston General Hospital
• Contact: Daren Heyland, MD
• Phone: 613-549-6666
• Email: dkh2[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria for Patients:

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.

• 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

Exclusion Criteria for Patients:

• 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

Inclusion Criteria for Family Member:

• 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).

Related Conditions & MeSH terms

• Critical Illness

Intervention

Behavioral:
• Nutrition Education Program
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)

Other:
• Decision Support Program
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

Locations

Country	Name	City	State
Australia	Gold Coast Health	Gold Coast	Queensland
Canada	University of Calgary	Calgary	Alberta
Canada	University of Ottawa	Ottawa	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Phoenix VA Medical Center	Phoenix	Arizona
United States	Barnes Jewish Hospital/Washington University	Saint Louis	Missouri
United States	Legacy Salmon Creek Medical Center	Vancouver	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Evaluation Research Unit at Kingston General Hospital	Canadian Institutes of Health Research (CIHR), Griffith University

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional adequacy during the ICU stay		Up to 30 days in ICU
Primary	Consumption of Oral Nutritional Supplements		First four weeks once on ward
Primary	Intake on hospital wards (3 day calorie count)		First four weeks once on ward
Primary	Hand grip strength	Hydraulic hand dynamometer	At or before hospital discharge or up to 90 days
Primary	Use of shared-decision making (OPTION tool)		Within first week in ICU
Primary	Change in decisional conflict	10-item Decisional Conflict Scale	1 week
Primary	Family satisfaction with decision-making		1 week
Primary	Overall family satisfaction with ICU		At ICU discharge, an average of 12 days