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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG075230 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Department Delirium Screening and Detection Program (ED-DDP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intervention period (3-9 months post program implementation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Implementation period (3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liron Sinvani, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institutes for Medical Research | Manhasset | New York | 11030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospital Site A Nurse Champions | The Emergency Department Delirium Screening and Detection Program (ED-DDP) intervention consisted of enrollment of Nurse Champion participants at participating ED sites. Nurse Champions were identified by site leaders before approaching for enrollment. All Nurse Champions received a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during their site's Implementation Period. Participant flow is reported during the Implementation Period only, as this is when all program components started and completed for each enrolled participant. The Emergency Department in Hospital Site A received the Implementation Period during months 4-6. |
| FG001 | Hospital Site B Nurse Champions | The Emergency Department Delirium Screening and Detection Program (ED-DDP) intervention consisted of enrollment of Nurse Champion participants at participating ED sites. Nurse Champions were identified by site leaders before approaching for enrollment. All Nurse Champions received a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during their site's Implementation Period. Participant flow is reported during the Implementation Period only, as this is when all program components started and completed for each enrolled participant. The Emergency Department in Hospital Site B received the Implementation Period during months 7-9. |
| FG002 | Hospital Site C Nurse Champions | The Emergency Department Delirium Screening and Detection Program (ED-DDP) intervention consisted of enrollment of Nurse Champion participants at participating ED sites. Nurse Champions were identified by site leaders before approaching for enrollment. All Nurse Champions received a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during their site's Implementation Period. Participant flow is reported during the Implementation Period only, as this is when all program components started and completed for each enrolled participant. The Emergency Department in Hospital Site C received the Implementation Period during months 10-12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Months 1-3 |
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| Months 4-6 |
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| Months 7-9 |
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| Months 10-12 |
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| Months 13-15 |
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Nurse champions enrolled in the ED-DDP program.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospital Site A | The Emergency Department in Hospital Site A received the following study sequence: 3 month Control Period, then a 3 month Implementation Period, then a 9 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Site nurses were not considered enrolled in the study but were assessed for this measure. | Posted | Count of Units | Site nurses who received Spot Check Form | Intervention period (3-9 months post program implementation) | Site nurses who received Spot Check Form | Site nurses who received Spot Check Form |
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During the 3-Month Implementation Period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospital Site A | The Emergency Department in Hospital Site A received the following study sequence: 3 month Control Period, then a 3 month Implementation Period, then a 9 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liron Sinvani, MD | Northwell Health | 646-864-6020 | ldanay@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2022 | Apr 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2022 | Apr 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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| 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. | 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. | 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. | 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). | Implementation period (3 months) |
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| BG001 | Hospital Site B | The Emergency Department in Hospital Site B received the following study sequence: 6 month Control Period, then a 3 month Implementation Period, then a 6 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. |
| BG002 | Hospital Site C | The Emergency Department in Hospital Site C received the following study sequence: 9 month Control Period, then a 3 month Implementation Period, then a 3 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Years of Practice | Number of years of experience as a nurse. | Number | Years |
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| Education | Highest level of educational degree obtained. | Count of Participants | Participants |
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| OG001 | Hospital Site B | The Emergency Department in Hospital Site B received the following study sequence: 6 month Control Period, then a 3 month Implementation Period, then a 6 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. |
| OG002 | Hospital Site C | The Emergency Department in Hospital Site C received the following study sequence: 9 month Control Period, then a 3 month Implementation Period, then a 3 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. |
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| Secondary | 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. | Posted | Count of Participants | Participants | Implementation period (3 months) |
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| Secondary | 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. | Site nurses were not considered enrolled in the study but were assessed for this measure. | Posted | Count of Units | Total number of nurses at site | Implementation period (3 months) | Total number of nurses at site | Total number of nurses at site |
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| Secondary | 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. | Posted | Count of Units | Electronic health records reviewed | Intervention period (3-9 months post implementation) | Electronic health records reviewed | Electronic health records reviewed |
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| Secondary | 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. | Posted | Count of Units | Training Components | Implementation period (3 months) | Training Components | Training Components |
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| Secondary | 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). | Site nurses were not considered enrolled in the study but were assessed for this measure. | Posted | Number | Days | Implementation period (3 months) | Total number of nurses at site | Total number of nurses at site |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Hospital Site B | The Emergency Department in Hospital Site B received the following study sequence: 6 month Control Period, then a 3 month Implementation Period, then a 6 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Hospital Site C | The Emergency Department in Hospital Site C received the following study sequence: 9 month Control Period, then a 3 month Implementation Period, then a 3 month Intervention Period. The Emergency Department Delirium Screening and Detection Program (ED-DDP) was delivered during Implementation Period only and consisted of identification and enrollment of Nurse Champion participants to receive a 1-day workshop and 3 tele-training sessions. Once Nurse Champions completed trainings, they provided baseline delirium training to all nurses at their site Emergency Department during the Implementation Period. Pre and post program data was collected during the Control Period and Intervention Period, respectively. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |