Clinical trial NCT05606328: Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program
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
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Delirium Screening
Delirium Detection
Emergency Department
Older Adults
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Accurate delirium screening by emergency department (ED) nurses (RE-AIM: Efficacy)
timeFrame: Intervention period (3-9 months post program implementation)
Secondary outcomes:
measure: Proportion of delirium champions who complete training (RE:AIM: Reach)
timeFrame: Implementation period (3 months)
measure: Proportion of emergency department nurses who complete training (RE-AIM: Reach)
timeFrame: Implementation period (3 months)
measure: Proportion of nurses who screen eligible patients (REAIM: Adoption)
timeFrame: Intervention period (3-9 months post implementation)
measure: Proportion of training program components that adhered to ED-DDP protocol (REAIM: Implementation/Fidelity)
timeFrame: Implementation period (3 months)
measure: Time required to train delirium champions and nurses (REAIM: Implementation/Time)
timeFrame: Implementation period (3 months)
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institutes for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Liron Sinvani, MD
role: PRINCIPAL_INVESTIGATOR
References: