Recruiting

Observational Study

Sponsor:

Clinical Evaluation Research Unit at Kingston General Hospital

Code:

NCT02920086

Conditions

Critical Illness

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Nutrition Education Program

Decision Support Program

Study Details

Brief 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.

Conditions

Critical Illness

Study ID

NCT02920086

Start date

May 9, 2017

Status verified date

Sep, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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ICU for 72 hours after initial screening (physician judgment) or for whom life-sustaining treatments are expected to be withdrawn in the subsequent 72 hours (as sufficient time will be required for implementation of the study interventions)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).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nutrition Education Program

Nutrition education for family members of an elderly critically ill patient

experimental: Decision Support Program

Decision support education for family members of an elderly critically ill patient

no intervention: Usual Care

No intervention

Interventions

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)

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

Primary outcome measure

  • 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 ]
  • Use of shared-decision making (OPTION tool) [ Time Frame: Within first week in ICU ]
  • Change in decisional conflict [ Time Frame: 1 week ]
  • Family satisfaction with decision-making [ Time Frame: 1 week ]
  • Overall family satisfaction with ICU [ Time Frame: At ICU discharge, an average of 12 days ]

Central Contacts and Locations

Central contacts

Daren Heyland, MD

613-549-6666dkh2@queensu.ca

Locations

Phoenix VA Medical Center

Recruiting

Phoenix, Arizona, United States, 85012

Barnes Jewish Hospital/Washington University

Recruiting

Saint Louis, Missouri, United States, 63110-1093

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Legacy Salmon Creek Medical Center

Recruiting

Vancouver, Washington, United States, 98686

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

University of Ottawa

Recruiting

Ottawa, Ontario, Canada

Sunnybrook Health Science Centre

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Clinical Evaluation Research Unit at Kingston General Hospital

Last update posted

Sep 9, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Clinical Evaluation Research Unit at Kingston General Hospital on 2019-09-09.