DeliriumED-DDPNCT05606328
Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program
A study testing Emergency Department Delirium Screening and Detection Program (ED-DDP) in people with Delirium, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Emergency Department Delirium Screening and Detection Program (ED-DDP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institutes for Medical Research
Manhasset, New York, 11030
About this study
Official title: Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency Department (ED): A Novel ED Delirium Screening and Detection Program
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:
Read more
- 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.
Read the 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.
- Conditions
- Delirium
- Being tested
- Emergency Department Delirium Screening and Detection Program (ED-DDP)
- Keywords
- Delirium Screening, Delirium Detection, Emergency Department, Older Adults
- Medical subject headings
- Delirium, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department Delirium Screening and Detection Program (ED-DDP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Period | Experimental | ED leadership at each site will identify 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The implementation period will take place over a period of 3 months. No data analysis will take place during the implementation period. Receives: Behavioral: Emergency Department Delirium Screening and Detection Program (ED-DDP) |
| Intervention Period | No intervention | The intervention period will take place 3-9 months after implementation of the ED-DDP program over a 15 month period, depending on when a site is randomized to receive the ED-DDP intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy)
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.
Measured: Intervention period (3-9 months post program implementation)
Secondary outcomes (5)
Proportion of Delirium Champions Who Complete Training (RE:AIM: Reach)
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.
Measured: Implementation period (3 months)
Proportion of Emergency Department Nurses Who Complete Training (RE-AIM: Reach)
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.
Measured: Implementation period (3 months)
Proportion of Nurses Who Screen Eligible Patients (REAIM: Adoption)
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.
Measured: Intervention period (3-9 months post implementation)
Proportion of Training Program Components That Adhered to ED-DDP Protocol (REAIM: Implementation/Fidelity)
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.
Measured: Implementation period (3 months)
Time Required to Train Delirium Champions and Nurses (REAIM: Implementation/Time)
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).
Measured: Implementation period (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start28 Feb 2023
- Primary completion12 Jan 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Liron Sinvani, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606328
- Sponsor's protocol ID
- 22-0681
- Other IDs
- R21AG075230
- Acronym
- ED-DDP
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2022
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency Department (ED): A Novel ED Delirium Screening and Detection Program
- ClinicalTrials.gov ID
- NCT05606328
- Acronym / sponsor ID
- ED-DDP / 22-0681
- Conditions
- Delirium
- Keywords
- Delirium Screening, Delirium Detection, Emergency Department, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation Period | Experimental | Behavioral: Emergency Department Delirium Screening and Detection Program (ED-DDP)ED leadership at each site will identify 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The implementation period will take place over a period of 3 months. No data analysis will take place during the implementation period. |
| Intervention Period | No intervention | –The intervention period will take place 3-9 months after implementation of the ED-DDP program over a 15 month period, depending on when a site is randomized to receive the ED-DDP intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency 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. | Behavioural | Implementation Period |
Primary outcome
Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy)
Time frame: 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.
5 secondary outcomes
Proportion of Delirium Champions Who Complete Training (RE:AIM: Reach)
Time frame: Implementation period (3 months)
Proportion of Emergency Department Nurses Who Complete Training (RE-AIM: Reach)
Time frame: Implementation period (3 months)
Proportion of Nurses Who Screen Eligible Patients (REAIM: Adoption)
Time frame: Intervention period (3-9 months post implementation)
Proportion of Training Program Components That Adhered to ED-DDP Protocol (REAIM: Implementation/Fidelity)
Time frame: Implementation period (3 months)
Time Required to Train Delirium Champions and Nurses (REAIM: Implementation/Time)
Time frame: Implementation period (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liron Sinvani, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Department Delirium Screening and Detection Program (ED-DDP) in people with Delirium, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy) (time frame: Intervention period (3-9 months post program implementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.