Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorPenn State University

About this trial

The goal of this step-wedge trial is to test the implementation of daily nurse screening for delirium in routine care and its impact on outcomes and complications in hospitalized older adults admitted to 6 general medicine/surgery units at 3 hospitals in Pennsylvania and Massachusetts.

The main question\[s\] it aims to answer are:

* 1\. To test the fidelity, accuracy, and durability of implementing daily nurse screening for delirium using the UB-CAM in routine care. * 2\. To evaluate the impact of UB-CAM delirium screening on patient and care partner centered outcomes assessed at one month follow-up interviews 3. To evaluate the impact of UB-CAM screening on rates of delirium complications (falls, pressure injury, aspiration) and adverse delirium management (psychoactive medication use, restraint use).

Participants (patients) will be assessed for delirium on study days 1, 2 and 3 (or until hospital discharge) and will be asked basic demographics. These patients will be contacted by phone 1 month after enrollment to collect information about inpatient facility use and to administer the Delirium Burden Patient Scale.

Participants (care partners) will be interviewed at the patient's discharge to complete the Alzheimer's Disease-8 scale. These care partners will be contacted by phone 1 month after enrollment to complete the Delirium Burden Caregiver Scale and to complete a Qualitative Interview which includes questions about communication and collaboration.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

General medicine (hospitalist) service

Age 70 or older

Expected hospital length of stay of 3 or more days

Disqualifiers

Inability to communicate adequately in English

Admitted for terminal care

Trial design

Design model

Single group

Treatments tested in this trial

  • READI-SET GO UB-CAM delirium screening into EHR

    Other intervention

    UB-CAM Delirium screening tool integrated into EHR with education on best practices for delirium management

Treatment groups

1,050 Participants
are divided into 2 treatment groups
Group A: Readi Set Go Patient Oriented SampleExperimental treatment 1 intervention
Group B: Readi Set Go Administrative SampleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aim 1: To Find the Percent Agreement Between the Nurse UB-CAM Screen and the Reference Standard Delirium Assessment (RSDA)

Accuracy is defined as the percent agreement between the nurse UB-CAM screen and the RSDA. While false negatives (low sensitivity) are most concerning since delirium is missed, false positives are problematic as well, as they lead to false labeling and unnecessary workups, which burden both patients and hospital staff. In subset analyses, the investigators will also consider sensitivity (among all RSDA positives) and specificity (among all RSDA negatives). Our sample size of 2360 assessments and target 20% delirium positivity rate (achieved in READI), will allow both analyses of accuracy, and subset analyses of sensitivity and specificity. Since each patient will contribute 1-3 assessments, the investigators will account for clustering in the analysis, as the investigators did in READI.11 Clinician identification of delirium during the "pre" period will be captured by EMR documentation. Absence of such documentation will be considered negative identification.

Time frame
Three consecutive hospital days
2

Aim 2: To Measure Healthy Days at Home (HDAH) as Defined by the Medicare Payment Advisory Commission

Our patient/care partner focus group told us that if hospitalized, their primary goal was to return home as soon as possible, and stay home. Healthy Days at Home (HDAH) is a measure developed in conjunction with the Medicare Payment Advisory Commission and is calculated: HDAH = 30 days - (Index hospitalization days + Mortality Days + Skilled Nursing Facility Days + Inpatient Rehabilitation Day + Long Term Hospital Days + Hospital Transfer/Readmission Days + Subsequent Emergency Department Visit Days) The investigators will obtain information on hospital length of stay and discharge disposition from the EMR. The investigators will get information on subsequent inpatient facility stays, readmissions, and ED

Time frame
One month post-hospital
3

Aim 3: To Measure Three Complications of Delirium

This outcome includes 3 delirium-related adverse events-falls, severe pressure injury, and aspiration pneumonia. Each occurs in 2-4% of all hospital discharges, but much more frequently in patients with delirium (relative risk for falls among delirious patients may be \> 20). Each prolongs length of stay, and increases need for post-discharge facility use, patient and care partner distress, and mortality. The investigators will design our UB-CAM app such that positive screens will present management tips that will address preventive strategies to reduce these complications. For instance, if a patient screens positive for delirium, feeding should occur out of bed or with the head of the bed at 90 degrees, reducing risk of aspiration. The investigators will identify these complications using incident reports (falls, pressure injury) and ICD discharge codes for each outcome, plus "not present on admission" to ensure these were not pre-existing conditions.

Time frame
From hospital admission through discharge, an average of 1 week

Secondary outcomes

1

Aim 1: Fidelity: To Find the Percent of Eligible Days With At Least One Completed Nurse Delirium Screen

Intervention fidelity is defined as the percent of eligible days with at least one completed nurse delirium screen. In READI, clinicians completed the UB-CAM screen in 97% of eligible days, but this was not a full-scale implementation. The fidelity outcome will be tracked through our EMR implementation program, which will also generate weekly adherence reports that will be shared with site nurse champions. This outcome will be measured only after implementation of delirium screening. Sustainability will be defined as screening completion rate in the study periods after the initial six-month launch.

Time frame
From hospital admission through discharge, an average of 1 week
2

Aim 2: Patient/Family Care Partner Distress

The investigators will use the recently developed and validated Delirium Burden scales for patients and care partners (DEL-B-P and DEL-B-C), which specifically ask about distressing symptoms and behaviors related to delirium and hospital staff reactions to them. These measures, co-developed by Drs. Marcantonio, Fick and Inouye, were chosen due to their direct relevance to delirium, and the investigators refer to them as distress rather than burden scales based on advice from our focus group. Both the DEL-B-P and DEL-B-C scales consist of 8 items, and can be completed by patients and family care partners in 2-3 minutes.

Time frame
One month after hospital discharge
3

Aim 3: Rate of Use of Physical Restraints or Use of Antipsychotic Medications

This outcome will focus on use of physical restraints, and use of antipsychotic medications for sedation. Physical restraints requiring physician orders occur in approximately 1% of all admissions. Antipsychotic use is more common, with rates of 7% among adults aged 65 and older admitted for non-psychiatric reasons. The investigators will identify use of restraints from physician orders, and new antipsychotic use from electronic medication administration records. This information will be obtained as part of the administrative data from each of the institutions. The investigators will design the UB-CAM app such that positive screens will trigger recommendations against use of restraints and antipsychotics in favor of non-pharmacological behavioral management strategies, and hypothesize that delirium screening will reduce these adverse management strategies.

Time frame
From hospital admission through discharge, an average of 1 week

Other outcomes

1

Aim 2: Patient/Care Partner Perceptions of Communication, Collaboration (Qualitative)

The investigators expect variable degrees of engagement by patients/care partners with our delirium screening program, depending on whether they screen positive for delirium. Therefore, the investigators will first ask whether they were contacted by hospital staff about the results of screening. Based on those responses, the investigators will utilize a semi-structured interview guide to elicit information about the experience including the quality of the communication, and whether this led to distress vs. security. The investigators will also ask care partners whether they were asked to collaborate in the plan of care around delirium. The investigators will analyze these results via qualitative methods

Time frame
One month after hospital discharge

Sponsors and contacts

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Penn State University

Lead sponsor

Mount Nittany Medical Center

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Penn State Health Milton S Hershey Medical Center

Collaborator