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Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program

Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency Department (ED): A Novel ED Delirium Screening and Detection Program

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05606328
Acronym
ED-DDP
Enrollment
18
Registered
2022-11-04
Start date
2023-02-28
Completion date
2024-10-08
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

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

Grounded in the RE-AIM framework, investigators will use mixed methods to conduct implementation outcome assessments of the ED-DDP for champions and nurses. A multimodal approach, using training logs, tele-observations, and EHR data, will assess quantitative outcomes during implementation/intervention periods: Reach (training completion), Efficacy (accurate screening tool use), Adoption (screening rates), and Implementation (fidelity/time of program delivery). Investigators will conduct semi-structured interviews (intervention period) to assess and explain: successes and challenges of training completion (Reach) and Adoption of delirium screening; adaptations made to ED DDP delivery (Implementation); and plan for Maintenance.

Interventions

BEHAVIORALEmergency Department Delirium Screening and Detection Program (ED-DDP)

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. No adaptations to the ED-DDP will occur between implementation sites and no data will be collected during implementation phases.

Sponsors

Northwell Health
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

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
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Nurse educators, managers, or bedside nurses self-identified or recommended by emergency department (ED) leadership to volunteer as a program site champion * Primarily working at a participating ED site * Commitment to program participation

Exclusion criteria

* Unable to meet program requirements, including attending champion workshop, agreement to observation and training via telehealth, and commitment to train department staff * Does not primarily work in the ED

Design outcomes

Primary

MeasureTime frameDescription
Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy)Intervention period (3-9 months post program implementation)Tele-observations will be used to asses screening accuracy, defined as the proportion of nurses who score at least 80% accuracy on the brief confusion assessment method (bCAM) use using a validated Spot Check Form. The investigators will observe a random sample of nurses (N=30, 10 at each ED site) performing a delirium screen in real-time. A successful outcome will be considered if computed proportion of nurses accurately using the bCAM tool is 80% or higher.

Secondary

MeasureTime frameDescription
Proportion of Delirium Champions Who Complete Training (RE:AIM: Reach)Implementation period (3 months)Champion training logs will be used to determine the proportion of champions who complete training (1-day workshop and 3 tele-training sessions) at each emergency department site. A successful outcome will be considered if computed proportion is 80% or higher.
Proportion of Emergency Department Nurses Who Complete Training (RE-AIM: Reach)Implementation period (3 months)Emergency department nurse training logs will be used to determine the proportion of nurses who complete at least 1 training session with a delirium champion at each ED site. A successful outcome will be considered if computed proportion is 80% or higher.
Proportion of Nurses Who Screen Eligible Patients (REAIM: Adoption)Intervention period (3-9 months post implementation)Electronic health record (EHR) data will be used to determine the proportion of nurses who document delirium screening in at least 80% of eligible patients. A successful outcome will be considered if computed proportion is 80% or higher. Data is reported as the number of patient records reviewed during the intervention period that contained a delirium screening by a emergency department nurse.
Proportion of Training Program Components That Adhered to ED-DDP Protocol (REAIM: Implementation/Fidelity)Implementation period (3 months)Training logs of delirium champions and ED nurses will be used to determine the proportion of training components (workshop, tele-training sessions, and bedside training of nurses by champions) that adhered to ED-DDP protocol. A successful outcome will be considered if computed proportion is 80% or higher.
Time Required to Train Delirium Champions and Nurses (REAIM: Implementation/Time)Implementation period (3 months)Data is reported as total number of days necessary to train 80% of nurses in the ED site. Training logs of delirium champions and ED nurses will be used to determine the time required to complete champion and ED nurse training. A successful outcome will be considered if 80% of delirium champion and ED nurses complete training within the implementation period (fewer than 90 days).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLiron Sinvani, MD

Northwell Health

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
Education
BS/BA
2 Participants
Education
MS/MA
1 Participants
Education
Other
0 Participants
Education
PhD/EdD/SciD
0 Participants
Education
Practice doctorate (MD, DNP, etc.)
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
3 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
2 Participants
Years of Practice
11-15 Years
0 Years
Years of Practice
1-5 Years
1 Years
Years of Practice
6-10 Years
7 Years
Years of Practice
Over 15 Years
4 Years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 60 / 6
other
Total, other adverse events
0 / 60 / 60 / 6
serious
Total, serious adverse events
0 / 60 / 60 / 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026