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Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program (ED-DDP)

Primary Purpose

Delirium

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency Department Delirium Screening and Detection Program (ED-DDP)
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Delirium focused on measuring Delirium Screening, Delirium Detection, Emergency Department, Older Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Feinstein Institutes for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Implementation Period

Intervention Period

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Time required to train delirium champions and nurses (REAIM: Implementation/Time)
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.

Full Information

First Posted
November 1, 2022
Last Updated
October 2, 2023
Sponsor
Northwell Health
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05606328
Brief Title
Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program
Acronym
ED-DDP
Official Title
Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency Department (ED): A Novel ED Delirium Screening and Detection Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium Screening, Delirium Detection, Emergency Department, Older Adults

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation Period
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Period
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emergency Department Delirium Screening and Detection Program (ED-DDP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accurate delirium screening by emergency department (ED) nurses (RE-AIM: Efficacy)
Description
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.
Time Frame
Intervention period (3-9 months post program implementation)
Secondary Outcome Measure Information:
Title
Proportion of delirium champions who complete training (RE:AIM: Reach)
Description
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.
Time Frame
Implementation period (3 months)
Title
Proportion of emergency department nurses who complete training (RE-AIM: Reach)
Description
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.
Time Frame
Implementation period (3 months)
Title
Proportion of nurses who screen eligible patients (REAIM: Adoption)
Description
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.
Time Frame
Intervention period (3-9 months post implementation)
Title
Proportion of training program components that adhered to ED-DDP protocol (REAIM: Implementation/Fidelity)
Description
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 Frame
Implementation period (3 months)
Title
Time required to train delirium champions and nurses (REAIM: Implementation/Time)
Description
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.
Time Frame
Implementation period (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liron Sinvani, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feinstein Institutes for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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