Family Support System for Delirium

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan Medical School, Ann Arbor, MI
Delirium
Family Support System - Behavioral
Eligibility
65+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a decision support system may help reduce delirium in older surgical patients.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Family Support System will improve 1 primary outcome, 10 secondary outcomes, and 11 other outcomes in patients with Delirium. Measurement will happen over the course of morning of surgery until day of hospital discharge, up to 30 days.

Day 30
36-Item Short Form Survey
30 days postoperatively
PROMIS Cognitive Abilities (Short Form 4a)
Day 2
Depressive symptoms as assessed by Hospitalized Anxiety and Depression Scale (HADS-D)
Day 3
Anxiety symptoms as assessed by Hospitalized Anxiety and Depression Scale (HADS-A)
Day 30
30-Day FAM-CAM Assessments
Day 30
Delayed Discharge - Cognitive Impairment
Discharge Disposition
Day 30
Length of Hospital Stay
New non-surgical site infection
Day 30
Multidrug resistant organism colonization
morning postoperative day one through afternoon of postoperative day three
Delirium
Delirium Severity
Falls
postoperative day one through postoperative day three
Agreement - FAM-CAM and research-based CAM assessments
Family intervention - duration of time
Family intervention - length of time, stimulating activity
Family intervention - proportion of daily tasks completed
HELP - duration of time
HELP - time to evaluation
HELP - visitation
Day 30
Hospital Readmission
Day 30
Mortality

Trial Safety

Trial Design

4 Treatment Groups

Usual Care Group
1 of 4
Family Support System
1 of 4
Combined Support Systems
1 of 4
HELP Support System
1 of 4
Active Control
Experimental Treatment

This trial requires 60 total participants across 4 different treatment groups

This trial involves 4 different treatments. Family Support System is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Family Support System
Behavioral
This arm will receive the Family Support system intervention only
Combined Support SystemsParticipants randomized to this arm will receive both HELP- and family-based support system interventions
HELP Support System
Behavioral
This arm will receive the HELP Support System intervention only
Usual Care GroupUsual care per surgical ward standards

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative day one through postoperative day three
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly postoperative day one through postoperative day three for reporting.

Who is running the study

Principal Investigator
P. V.
Prof. Phillip Vlisides, Assistant Professor of Anesthesiology
University of Michigan

Closest Location

University of Michigan Medical School - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least one family member or caretaker will be available on each of the first three postoperative days for trial operations. show original
People aged over 70. show original
is considered safe in pregnant women Pregnant women can safely undergo major non-cardiac, non-intracranial neurologic, and non-major vascular surgery. show original
We anticipate that you will need to stay with us for at least 72 hours. show original

Patient Q&A Section

What are common treatments for delirium?

"This survey was designed for acute care centers but may not reflect the usual treatment given in residential care settings and hospital-based geriatric patients. It is possible that the results would be different if samples reflected the usual treatment received in institutionalized populations. This survey provides a snapshot of delirium screening and treatment. It provides important information that is helpful in developing better quality standards for delirium treatment in older adults." - Anonymous Online Contributor

Unverified Answer

What are the signs of delirium?

"Signs of delirium include impaired or disturbed consciousness, and inability to concentrate or remember things. In those with dementia, delirium is the strongest factor related to hospitalization of patients with dementia." - Anonymous Online Contributor

Unverified Answer

Can delirium be cured?

"Despite an increasing number of studies implicating delirium in worsening cognitive function, only a few studies on delirium therapies exist so far. Given the lack of a rigorous definition of delirium and the lack of evidence for beneficial effects, it is unlikely that therapeutic interventions will be developed in the near future. This article reviews the existing studies to examine whether the use of antidepressant drugs and deep sleep deprivation therapy, known to reduce delirium or otherwise reduce agitation and anxiety, may be able to provide clinical benefit in patients with delirium." - Anonymous Online Contributor

Unverified Answer

How many people get delirium a year in the United States?

"About 4 million people are hospitalized for delirium each year in the United States. Approximately 11 million individuals aged 65 years and older suffer from dementia each year." - Anonymous Online Contributor

Unverified Answer

What is delirium?

"Delirium is a transient mental state of confusion and disorientation that may occur in all age ranges and is commonly associated with old age. It is a medical emergency requiring immediate attention." - Anonymous Online Contributor

Unverified Answer

What causes delirium?

"Although it is frequently argued that delirium is an unavoidable consequence of older hospitalized people, the cause of delirium is likely to be multifactorial, with a complex mix of biological, social and psychological factors." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for delirium?

"Given the relatively low risk of clinically meaningful adverse events in clinical trials, our results call for a cautious approach to clinical trials evaluating the use of medications for delirium, especially for patients who present with severe delirium, high frailty scores, or multiple comorbidities." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of delirium?

"The number of medical conditions is quite substantial in delirious patients who present before admission to the emergency department. The number of delirious patients will vary inversely with the size of the population in which the ED is located and the percentage of elderly. The most frequent causes of delirium are related to the neurological deficit as a result of dementia and neurodegenerative conditions. The development of delirium is influenced by numerous factors, and the genesis of delirium is multifactorial. As yet, no test can prove the existence of delirium. This justifies the clinical use of an interdisciplinary approach, including the use of health care professionals, who are able to deal with specific symptoms." - Anonymous Online Contributor

Unverified Answer

How serious can delirium be?

"The prevalence and risks for mortality associated with delirium are both increased and increased in serious elderly age groups. The risk for cognitive decline can be significant in delirious elderly if they do not recover within a year. Furthermore the risk of experiencing a new episode of delirium seems to increase with increasing age." - Anonymous Online Contributor

Unverified Answer

Has family support system proven to be more effective than a placebo?

"[In this small study, a family-based support system in the inpatient setting was more effective than a placebo in relieving some of the psychological distress experienced by the elderly in long-term care residents with delirium ]. However, this approach was not superior to regular care, in terms of other outcome measures. Clinical trials are urgently needed to verify whether this family-based support system can be used to help prevent or delay delirium." - Anonymous Online Contributor

Unverified Answer

Does family support system improve quality of life for those with delirium?

"Family support group membership is a common treatment tool of the elderly population. Family support group can improve satisfaction with QOL for those who have delirium." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating delirium?

"There is a huge gap between the needs, and the interventions of patients and doctors alike in the area of delirium. While there have certainly been advancements in many aspects of delirium treatment, whether we have progressed significantly is not necessarily evident. The main concern in delirium management should not be the current evidence-supported interventions of delirium itself, but rather the general practitioners ability to treat its potential causes, i.e. an underlying medical problem, or a patient with a co-existing one, or a lack of knowledge and training for the health care professionals to recognize its early signs, thus being better informed to intervene to prevent its occurrence." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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