Clinical trial NCT05118867: Improve the Patients' Recovery With Family- Caregivers to End Delirium
Official title: Improve the Patients' Recovery by Engagement and Partnerships With Family- CaregiveRs to End Delirium (iPREPARED) - A Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Delirium
Keywords: Aged 60 years old or older
Hospitalized with a risk of confusion
At risk of falling
At risk of vision or hearing impaired
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research is being done to find out if patients and caregivers who use the iPREPARED mobile health technology experience less delirium, a type of acute confusion, and if they do experience delirium, the delirium will be less severe and distressful.

iPREPARED prepares patients and caregivers on what to expect during their hospital stay and provides instructions and resources on how to use non-pharmacologic strategies like re-orientation, distraction techniques, and other activities to maintain their brain health during their hospital stay.

Detailed description: The purpose of this pilot study is to assess the feasibility, acceptability, and preliminary efficacy of the iPREPARED mobile health technology to reduce delirium incidence in a two-group, pilot randomized- controlled clinical trial. In the context of this intervention, the caregiver is defined as a patient-identified family member or friend that can accompany the patient in their hospital journey.

Aim 1: Determine the feasibility, acceptability, and usability of the iPREPARED intervention for use by older hospitalized adults (\>60yo) and their caregivers (patient-caregiver dyad).

Aim 2: To estimate the effect size needed to reduce the incidence of delirium in participants using the iPREPARED intervention.

Aim 3: Identify patient-caregiver reported strategies to improve the usability of the iPREPARED intervention.

Secondary Outcomes:

1. Association between delirium incidence and self-rated health status (GSRH).
2. Association between delirium incidence, severity, and delirium-related distress (NCCN Distress thermometer) and resiliency (BRS resiliency scale).
3. Acute stress measured by the IPAT will be compared across the two groups. Acute stress measured by the Intensive Care Psychological Assessment Tool (IPAT) will be less in the intervention group.
4. Delirium-related distress will be analyzed across the two groups. Delirium-related distress measured by the NCCN Distress Thermometer will be less in the intervention group.
5. Plasma and serum biomarker differences between groups and between delirium/non- delirium cohort.
6. Clinical outcomes including adverse hospital events (falls, nosocomial infections, aspirations), length of hospital stay, discharge disposition, mortality and 30-day readmission rates will be collected and examined between groups:

   1. Nosocomial infection is defined as a diagnosis not present on admission and occurred after 48 hours of hospital admission and includes UTI, Pneumonia, Decub ulcers, Cellulitis, CAUTI's and CLABSI's

Eligibility criteria: Patient Inclusion Criteria:

* 60 years of age or older
* Have 1 risk factor for delirium (pre-existing cognitive impairment, vision/hearing impairment, identified as high risk for falls, illness rated as severe)
* Estimated length of stay of 24 hours or more in hospital
* Have an informal caregiver (18 years of age or older, family member or friend) willing to participate

Patient Exclusion Criteria:

* Patient lacks capacity to consent
* Unable to communicate or participate in study due to language barriers or sensory deficits
* Prisoners
* Documented history of dementia in the medical record
* Patient admitted to hospice service or actively dying
* Delirium present upon admission to hospital
* COVID-19 positive test

Caregiver Inclusion Criteria:

* 18 years of age or older
* Family member, friend, or neighbor of the patient willing to participate in the study and support the patient during the study period (support can be in-person or virtual)

Caregiver Exclusion Criteria:

- Unable or unwilling to participate due to language barriers, availability, or other communication barriers

Primary outcomes:
measure: Feasibility of study recruitment to intervention study
timeFrame: Number approached for study that were eligible and number consented into study over 2-year study.
measure: Usability and acceptability of digital technology
timeFrame: From enrollment through study completion, an average of 4 days
measure: Delirium incidence
timeFrame: From enrollment through study completion, an average of 4 days
Secondary outcomes:
measure: Delirium-related distress
timeFrame: From enrollment through study completion, an average of 4 days
measure: Resiliency
timeFrame: At enrollment into study
measure: General Self-Rated Health Status
timeFrame: At enrollment into study
measure: Delirium Severity
timeFrame: From enrollment through study completion, an average of 4 days
measure: Acute Stress associated with the hospitalization
timeFrame: From enrollment through study completion, an average of 4 days
measure: Biomarkers
timeFrame: At enrollment and Day 4
measure: Discharge disposition
timeFrame: From enrollment through study completion, an average of 4 days
measure: 30-day readmission rates
timeFrame: 30-days after hospital discharge date
measure: Length of hospital stay
timeFrame: From enrollment through study completion, an average of 4 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Heidi Lindroth, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: