Delirium
Conditions
Keywords
Delirium Screening, Delirium Detection, Emergency Department, Older Adults
Brief summary
Delirium occurs in up to 20% of older adults presenting to the Emergency Department (ED) and is associated with poor outcomes. Failure to identify patients with ED delirium not only prevents initiation of mitigation strategies, but is also a barrier to advancing the field in terms of evaluating management and clinical outcomes. This project studies the potential of an ED Delirium Detection Program (ED-DDP), developed to address the need for consistent and accurate ED delirium detection. This research will have two objectives: * Aim 1 will conduct a pilot stepped wedge cluster randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to determine preliminary efficacy of the detection training program, and * Aim 2 will use a mixed methods approach to assess RE-AIM implementation outcomes (Reach, Efficacy, Adoption, Implementation, and Maintenance) of the training program. Aim 1 will consist of a multicomponent 1-day delirium champion workshop where the training is delivered, real-time direct observation/training of champions via telehealth, practical training of nurses throughout each ED by champions, and patient chart review. In Aim 2, the investigators will assess implementation outcomes using training logs, tele-observation, interviews with champions and nurses, and electronic medical record screening. The overarching aim of this proposal is to determine the preliminary efficacy of the training program for improving ED delirium screening, detection, and management in older adults, while also evaluating implementation outcomes of the program for champions/nurses. The investigators will use findings from this study to inform a full-scale SW-CRT to evaluate the impact of the program on patient outcomes at Northwell Health. The long-term goal of this study is to implement and disseminate a comprehensive ED-DDP that will improve screening, detection, and management of ED delirium in older adults.
Detailed description
Every three months, with the exception of when a site is in their implementation period, trained study staff members will conduct retrospective in-depth chart reviews on 250 randomly selected eligible patient visits per ED site. These chart reviews will assess presence of delirium as well as any corresponding delirium documentation, including the brief confusion assessment method (bCAM) and delirium mitigation and management strategies employed during the patient's ED visit. Charts will be pulled based on dates the participating site is within their control or intervention period (no chart review will take place during program implementation). A total of N=1,000 patients per ED will be reviewed. Two delirium experts will perform chart checks and adjudicate any uncertain cases.
Interventions
BEHAVIORALED Delirium Screening and Detection Program (ED-DDP)
The intervention arm will have standardized delirium screening by nurses using the brief confusion assessment method (bCAM) in the EHR and will receive the ED-DDP. The ED-DDP will consist of: 1) a multicomponent 1-day delirium champion workshop; 2) real-time direct observation/training via telehealth (tele-training); and 3) training of nurses by champions. Champions will participate in a 1-day workshop, consisting of patient testimonials, small group discussions, delirium and screening tool use (didactics), and role-playing. Following the workshop, champions will receive 3 tele-training sessions; 2 to provide direct observation/feedback while the champion performs a bedside delirium screen, and 1 to provide direct observation/feedback of the champion providing training to the nurse. Once delirium champions complete training, they will provide bedside delirium training for all ED nurses.
Sponsors
Northwell Health
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This study is a pilot stepped wedge cluster randomized trial (SW-CRT) of three diverse emergency department (EDs) randomized to receive the intervention at 3-month intervals over a 15-month period. Time of crossover from the control to intervention period will be unidirectional, and each crossover sequence will allow for a 3-month implementation period where data will not be collected.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presenting to a participating study site emergency department (ED) during control or intervention periods * Survival to ED discharge or to hospital admission
Exclusion criteria
* Presenting to a participating study site ED during ED-DDP implementation periods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Positive Delirium Screens Among Those With Delirium | Change from baseline to 9 months | Delirium detection is defined as the change in the proportion of documented delirium (i.e., the word delirium appears in the chart or there is a positive brief confusion assessment method \[bCAM\]) over time from baseline to 9 months (every 3 months), among patients with delirium. To identify the sample of patients with delirium, trained research staff will use a validated approach to conduct retrospective in-depth chart reviews to assess for ED presence of delirium (sensitivity 74%, specificity 83%) among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). Two delirium experts will perform chart checks and adjudicate any uncertain cases. To assess change over time, data will be reported as total charts with positive delirium screens pre ED-DDP (Control Period) and post ED-DDP (Intervention Period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eligible Patients Who Receive Delirium Screening | Change from baseline to 9 months | Analysis of delirium screening will be defined as proportion of eligible patients screened for delirium using electronic health record (EHR) brief confusion assessment method (bCAM) documentation during their ED visit. Analysis will be conducted on a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). To assess change over time, data will be reported as total charts of eligible patients who receive delirium screening pre ED-DDP (Control Period) and post ED-DDP (Intervention Period). |
| Proportion of Eligible Patients Who Receive Safety Precautions | Change from baseline to 9 months | Analysis will be defined as proportion of older adults with any order for safety precautions (fall, aspiration, or wandering) during their ED visit among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period).To assess change over time, data will be reported as total charts of eligible patients who receive delirium screening pre ED-DDP (Control Period) and post ED-DDP (Intervention Period). |
| Proportion of Eligible Patients Who Receive Physical and Chemical Restraints for Behavioral Symptoms | Change from baseline to 9 months | Analysis will be defined as proportion of older adults receiving benzodiazepines, antipsychotics, diphenhydramine, or restraints for behavioral symptoms during their ED visit among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). To assess change over time, data will be reported as total charts of eligible patients who receive delirium screening pre ED-DDP (Control Period) and post ED-DDP (Intervention Period). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLiron Sinvani, MD
Northwell Health
Participant flow
Recruitment details
250 patient charts from each of three participating EDs will be randomly selected every three months during the 15-month stepped-wedge ED-DDP program, with the exception of when an ED is having the program implemented. Thus, chart reviews will take place during Control Period and Implementation Periods only (no patient data is collected during implementation periods). A total of 1,000 patients per site and 3,000 patients overall will be randomly selected throughout the program.
Pre-assignment details
Only charts representing patients aged 65 years or older who presented to a participating ED during control or intervention periods and survived to ED discharge or hospital admission were eligible to be electronically randomized. Each chart was checked again for eligibility after randomization and removed as a protocol violation if eligibility criteria was not confirmed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 77.5 Years STANDARD_DEVIATION 8.6 |
| Charlson Comorbidity Index (CCI) | 6.8 score on a scale STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 229 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1137 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 132 Participants |
| Race (NIH/OMB) Black or African American | 282 Participants |
| Race (NIH/OMB) More than one race | 586 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 90 Participants |
| Race (NIH/OMB) White | 974 Participants |
| Sex: Female, Male Female | 870 Participants |
| Sex: Female, Male Male | 612 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,456 | 0 / 1,492 |
| other Total, other adverse events | 0 / 1,456 | 0 / 1,492 |
| serious Total, serious adverse events | 0 / 1,456 | 0 / 1,492 |
Outcome results
None listed