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Behavioral Intervention
Palliative Care App for Critical Illness in Older Adults (PCplanner Trial)
N/A
Waitlist Available
Led By Christopher Cox, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 1 (baseline), time 3 (target ~1 week post-randomization), and time 4 (3 months post-randomization)
Awards & highlights
PCplanner Trial Summary
This trial will test a mobile app platform (PCplanner) that automates the identification of high-risk ICU patients, cultivates family engagement, and facilitates the delivery of care to those with a high burden of need. The key hypothesis is that compared to usual care, PCplanner will reduce family caregivers' unmet needs and psychological distress, increase the frequency of goal concordant treatment among older adult patients, and reduce hospital length of stay.
Who is the study for?
This trial is for older adults (50+) in ICUs with conditions like dementia, severe stroke, or organ failure. They must have been admitted to the ICU for at least 24 hours and meet one of nine high-risk criteria such as multiple hospital stays or poor functioning. It's not suitable for those who don't meet these specific health conditions.Check my eligibility
What is being tested?
The study tests a mobile app called PCplanner that helps identify ICU patients needing palliative care by using data from their health records. The aim is to see if this app can better support family caregivers, align treatments with patient goals, and potentially shorten hospital stays compared to usual care.See study design
What are the potential side effects?
Since PCplanner is a digital tool designed to improve care coordination rather than a medical treatment, it does not have physical side effects. However, its impact on caregiver stress levels and healthcare delivery will be closely monitored.
PCplanner Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time 1 (baseline), time 3 (target ~1 week post-randomization), and time 4 (3 months post-randomization)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 1 (baseline), time 3 (target ~1 week post-randomization), and time 4 (3 months post-randomization)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score
Secondary outcome measures
Generalized Anxiety Disorder 7-Item scale (GAD-7)
Goal concordant care
Patient Health Questionnaire 9-Item scale (PHQ-9)
+4 morePCplanner Trial Design
2Treatment groups
Active Control
Group I: Usual care controlActive Control1 Intervention
Usual care
Group II: InterventionActive Control1 Intervention
PCplanner intervention during hospitalization
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,773 Total Patients Enrolled
10 Trials studying Palliative Care
28,048 Patients Enrolled for Palliative Care
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,334 Total Patients Enrolled
5 Trials studying Palliative Care
429 Patients Enrolled for Palliative Care
Christopher Cox, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
145 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are in a state of severe shock and have been receiving medication to increase your blood pressure for at least 4 hours.You have a type of memory loss called dementia, like Alzheimer's disease or other types.You have had a very serious illness where multiple organs in your body are not working properly, such as your lungs, kidneys, brain, heart, or liver.You recently had a severe stroke or head injury.You have at least one of nine characteristics that put you at high risk.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are contributing to this research endeavor?
"Affirmative, clinicaltrials.gov proclaims that this research is actively recruiting patients as of January 26th 2022. This trial was first posted on February 22nd 2021 and is aiming to enlist 150 individuals from 1 medical centre."
Answered by AI
Are there any slots available for this research project?
"The trial is actively recruiting, as indicated on clinicaltrials.gov – it was initially announced in February 2021 and has seen its latest update at the end of January 2022."
Answered by AI
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