care.coach Avatar (HELP-Protocolized) for Delirium

Phase-Based Estimates
1
Effectiveness
2
Safety
IU Health, Indianapolis, IN
Delirium+1 More
care.coach Avatar (HELP-Protocolized) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Delirium

Study Summary

This study is evaluating whether an avatar may help reduce falls, delirium, and the need for sitters.

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Eligible Conditions

  • Delirium
  • Falls Injury

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether care.coach Avatar (HELP-Protocolized) will improve 2 primary outcomes, 5 secondary outcomes, and 2 other outcomes in patients with Delirium. Measurement will happen over the course of Through study completion, an average of 4 days.

Year 2
Unit Fall Injury Rate
Unit Fall Rate
Day 4
Change in Cognitive Function
Change in Delirium Severity
Delirium Resolution
Falls
Falls with Injury
Incident Delirium
Patient Sitter Utilization

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
care.coach Avatar

This trial requires 2400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Care.coach Avatar (HELP-Protocolized) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

care.coach Avatar
Behavioral
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: quarterly (3 calendar months), for 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly quarterly (3 calendar months), for 2 years for reporting.

Closest Location

IU Health - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

Patient Q&A Section

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

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

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About 21% of people admitted to the hospital in 2014 will have a post-acute episode of delirium, with an onset in an acute care setting.

Unverified Answer

What are common treatments for delirium?

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For most people, symptoms of delirium resolve within 1 to 7 days, and most who do not improve within this time period require medical care for their symptoms. A minority of patients improved and did not need prolonged medical care, and no patients needed an extended course of pharmacological or medical therapy.

Unverified Answer

What are the signs of delirium?

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In older people who are admitted to hospital, symptoms of delirium will be present. If symptoms become worse, delirium may cause confusion, irritability, aggression, or even hallucinations.

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Can delirium be cured?

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There were no statistically significant differences between the two groups for the outcome measures assessed. The authors are thus unable to confirm any positive effects of post-surgery delirium or post-surgery agitation on outcome for that patient cohort. Recent findings of this study suggest that the outcome assessed did not translate into any improved post-surgery recovery for the patient population under observation.

Unverified Answer

What is delirium?

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Delirium is a state of confusion characterized by disorientation that lasts for less than 24h. It usually accompanies another underlying disease. It occurs often in seniors but also occurs in newborns. It is relatively common as about 30% of hospitalized elderly persons have at least one episode of delirium on their inpatient stay. Delirium is associated with disability, mortality and hospital admissions.\n

Unverified Answer

What causes delirium?

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The study suggests that, when in recovery, patients perceive that their experiences of delirium are different to those of the recovery phase. While perceptions may influence nursing practice and research results from the study, the relationship is unclear.

Unverified Answer

Have there been any new discoveries for treating delirium?

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The prevalence of delirium in older hospitalized patients is high as well as the proportion of inpatients who are affected by delirium. There is also a need to reduce the high mortality observed among inpatients with delirium.

Unverified Answer

Is care.coach avatar (help-protocolized) typically used in combination with any other treatments?

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The CACHA program can be used interchangeably with the standard care for the ICU without significant effect. The study has not shown any significant differences regarding the ICU stay duration, length of stay, or incidence of VAP. Although it would be difficult to change the standard care, if the CACHA program were proven to be effective the program could be recommended as part of the standard protocol. The CACHA software cannot provide the same clinical services that the standard care does and the clinical effects of the program need to be evaluated before a definite recommendation on the use of CACHA can be made.

Unverified Answer

What is the primary cause of delirium?

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[E-cigarette] use is the primary cause of delirium, particularly for those who have been hospitalized. Other modifiable risk factors for delirium in the hospital setting may include use of benzodiazepines, antipsychotics, alcohol, or use of sedatives or other medicines. Efforts to reduce the intake of e-cigarette products in the hospitalized setting may lessen delirium. The use of e-cigarettes has been implicated in a range of health conditions including acute cardiac events and acute pulmonary events. These preliminary findings suggest e-cigarette use increases the risk of delirium and may therefore be contributing to the growing numbers of hospitalizations around the world.

Unverified Answer

Has care.coach avatar (help-protocolized) proven to be more effective than a placebo?

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As more research emerges there will be more data in support of the use of CAV. More research in the forms outlined below will continue for at least several years to establish any more definitive information.

Unverified Answer

Have there been other clinical trials involving care.coach avatar (help-protocolized)?

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This case discusses the process of developing a Help-Protocol, the process of implementing protocolized care, and the impact of the Help-Protocol. This information could aid researchers or health care managers interested in implementing protocolized care, such as in older adults with multiple chronic conditions.

Unverified Answer

How serious can delirium be?

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There is a high rate of adverse outcomes when delirium occurs; and the outcome is worse for patients who were admitted to the ICU. The duration of delirium is associated with a higher risk of dying in the hospital.

Unverified Answer
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