Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults
Overview
- Phase
- Not Applicable
- Intervention
- Multi-component Family Support Intervention
- Conditions
- Critical Illness
- Sponsor
- University of Pittsburgh
- Enrollment
- 1039
- Locations
- 14
- Primary Endpoint
- Patient and family centeredness of care
- Status
- Completed
- Last Updated
- yesterday
Overview
Brief Summary
The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that.
Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.
Detailed Description
The Family Support Tool intervention is designed to help families navigate the emotional, psychological, and cognitive complexities of being a surrogate for an incapacitated critically ill patient and also to enhance the timeliness and quality of clinician-family communication. The intervention consists of three components: 1. Proactive clinician-family meetings within 48 hours of enrollment and every 5-7 days thereafter. 2. Family members complete sections of an interactive web-based tool upon study enrollment, before family meetings, and any other time they wish. Family members can access the tool anywhere via computer, tablet, or mobile phone. The first section of the tool is completed on the first day of study enrollment and contains: video messages supporting families including stories from other families and their experiences and coping strategies, tips on self-care and links to hospital resources. The second and third sections of the FST are completed before scheduled clinician-family meetings on study day 2-3 and again 5-7 days later. These sections of the tool contain: videos detailing what to expect during family meetings, interactive exercises and prompts about patient values, prognosis, care expectations and treatment leanings to help prepare for family meetings. The study team will provide families a printed summary sheet of their main questions for the ICU team that they are encouraged to bring to the family meeting. 3. Before each scheduled family meeting the ICU team receives a written report that summarizes the family's main questions and concerns, information about the patient's values and preferences, surrogates' prognostic expectations, and a visual display of their unmet PC needs.
Investigators
Douglas White
Professor of Critical Care Medicine
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •within 5 days of ICU admission
- •MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
- •Greater than 5 ICU days during the current hospitalization
- •Age \<18 years
- •Cannot read or understand English
- •Cannot complete questionnaires due to physical or cognitive limitations
- •Has no access to or cannot travel to access the internet
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
Multi-component Family Support Intervention
Intervention: Multi-component Family Support Intervention
Control
Usual ICU care
Outcomes
Primary Outcomes
Patient and family centeredness of care
Time Frame: 3 months after hospital discharge
12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.
Secondary Outcomes
- Satisfaction with ICU care(3 months after hospital discharge)
- Unmet palliative care needs(Measured at day 5 post-randomization)
- Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care(6 months after hospital discharge)
- ICU and hospital length of stay(6 months after hospital discharge)
- Duration of mechanical ventilation(6 months after hospital discharge)
- Clinician-family conflict(Measured at day 5 post-randomization)
- Perceived effectiveness of Family Support Tool(Measured at day 5 post-randomization)
- Risk of post-traumatic stress disorder(6 months after hospital discharge)
- Resource utilization(3 months and 6 months after hospital discharge)
- Proportion of patients enrolled in hospice during index hospitalization(6 months after hospital discharge)
- Cost of index hospitalization(6 months after hospital discharge)
- Surrogates' clarity about patient values and preferences(Measured at day 5 post-randomization)
- Surrogates' symptoms of anxiety and depression(6 months after hospital discharge)
- Time to hospice(6 months after hospital discharge)
- Composite measure of goal-concordant care(3 months after hospital discharge)
- Surrogates' prognostic awareness(Measured at day 5 post-randomization)
- Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization(6 months after hospital discharge)