Clinical trial NCT06668636: Examining the Effectiveness and Implementation of the Emergency Department Patient-Activated Transition to Care At Home Tool
Official title: Examining the Effectiveness and Implementation of the Emergency Department Patient-Activated Transition to Care At Home (ED-PATCH) Tool: a Mixed Methods Hybrid Type 1 Design Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Emergency Department Discharge Communication
Keywords: emergency department
discharge communication
discharge instructions
mobile applications
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 12000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study will employ an interrupted time series design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to examine the effectiveness and implementation of the Emergency Department Patient-Activated Transition to Care at Home (ED-PATCH) tool, which is used by patients to manage information during their visit to the emergency department. The main aims of the trial are:

* To study whether ED-PATCH works well in Canadian emergency department settings
* To understand the context and strategies impacting the implementation of ED-PATCH in Canadian emergency department settings

ED-PATCH is an electronic tool accessed using a smartphone or tablet that patients and caregivers can use to create their own summary of what happened during their visit to the emergency department. Using a questionnaire format, the tool prompts users to enter information about their symptoms, tests and procedures done during the visit, diagnosis, medications given, and their plans after leaving the emergency department. A healthcare provider checks that the information is correct before the summary is locked and emailed to the patient.

Researchers will compare data collected before ED-PATCH is launched and after it is launched to learn if the tool reduces return visits to the emergency department and other outcomes such as participants' stress, memory and understanding of their visit, health status, and care experiences.

Detailed description: When patients and caregivers leave the emergency department (ED) without fully understanding the care provided and the information shared during their visit, it can impede their ability to effectively manage their care at home. Effective discharge communication can reduce return visits, helping keep ED patient volumes manageable, and improve patient and caregiver outcomes. Opportunities exist to improve patient-provider discharge communication and ensure patients and caregivers have mastery of the knowledge needed to manage their health condition after they leave the ED. Novel health technology solutions have shown some potential to enhance discharge communication practice.

Emergency Department Patient-Activated Transition to Care at Home (ED-PATCH) is a discharge communication tool that is activated and managed by patients or their caregivers to record important information shared during the ED visit. Patients receive ED-PATCH in the waiting room or immediately upon placement in the assessment room and use it to track important information throughout their visit. The tool will support tracking information shared during the ED visit including (1) information about diagnosis; (2) details about treatments, tests and procedures; (3) reconciled and new medications; and (4) treatment plans including expected course of illness, signs and symptoms to watch for and when to return to the ED. Prior to discharge, the patient or caregiver shares the summary of their notes with an ED provider who confirms or clarifies the information captured. The patient-generated discharge summary is then sent electronically to the patient or caregiver to be added to their own personal health record.

The primary aim of this study is to evaluate the effectiveness of ED-PATCH in Canadian adult and pediatric emergency department settings. The secondary aim is to better understand the context and strategies for implementation of ED-PATCH in Canadian adult and pediatric emergency department settings. The objectives are to (1) evaluate the effectiveness of ED-PATCH on patient recall and comprehension of information during an emergency department visit; (2) evaluate the effectiveness of ED-PATCH on patient experience with emergency care; (3) evaluate the impact of ED-PATCH on health care provider and health system outcomes; (4) explore the determinants (patient/caregiver, provider, and system factors) of ED-PATCH adoption in emergency practice settings; and (5) describe the implementation strategies employed to promote uptake of ED-PATCH.

Effectiveness and implementation will be investigated concurrently in this study using a mixed methods hybrid type 1 effectiveness-implementation design with an integrated knowledge translation (iKT) approach. Effectiveness-implementation hybrid designs have a dual focus on clinical effectiveness and implementation. Quantitative measures (e.g., rate of ED admissions) will be used to evaluate intervention effectiveness while mixed methods (qualitative and quantitative) will be used to describe barriers and enablers to implementation and/or evaluate implementation outcomes such as feasibility, reach, adoption, and sustainability.

The investigators will use an interrupted time series (ITS) design to address the first two objectives and estimate the effect of ED-PATCH on the aggregate primary outcome measures at ED sites in Nova Scotia, Quebec, Alberta, and Ontario. Primary and secondary outcomes will be measured up to 18 months pre-implementation and 18 months post-implementation. The investigators will address the remaining objectives by tracking implementation of ED-PATCH and conducting semi-structured, qualitative interviews with a subset of participants and ED providers.

Integration of effectiveness and implementation findings will be guided by RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance), a systems-level evaluation framework used extensively to assess intervention implementation and sustainability. RE-AIM will be adapted using a health equity lens to strengthen the evaluation.

Eligibility criteria: Inclusion Criteria:

* Youth and adults aged 14 years and older are eligible to participate on their own behalf; caregivers or support people aged 14 years and older are eligible to participate on behalf of children younger than 14 years old
* Seeking emergency care at participating sites on their own behalf or as a caregiver or support person for another patient
* Discharged home from the ED
* Able to understand and read English or French
* Meet Canadian Triage Acuity Scale (CTAS) between 2-5
* Provide informed consent

Exclusion Criteria:

* Infants and children aged under 14 years are not eligible to participate on their own behalf
* Admitted to hospital after seeking emergency care
* Unable to understand or read English or French
* CTAS of 1
* Not providing informed consent

Primary outcomes:
measure: Monthly Rate of ED and Hospital Readmissions
timeFrame: 7 days post-index visit
Secondary outcomes:
measure: Patient-Reported Outcomes (PROM-ED)
timeFrame: At baseline and 72 hours after discharge
measure: Perceived Stress
timeFrame: At baseline
measure: Patient Experiences of Care Transitions (ED CAHPS)
timeFrame: 72 hours after discharge
measure: Recall and Comprehension Survey of Information Shared During the ED Visit
timeFrame: 72 hours and 7 days after discharge
measure: Health Care Utilization (Length of Stay, Return Visits, Hospital Admissions)
timeFrame: 72 hours after discharge, 7 days after discharge, 30 days after discharge
measure: Implementation Tracking
timeFrame: 18 months post-implementation
measure: Patient and Provider Perceptions of Implementation
timeFrame: Patient participants: 4 weeks post-discharge; Provider participants: 8 weeks after ITS closure
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health
state: Nova Scotia
city: Kentville
country: Canada
facility: Valley Regional Hospital
state: Nova Scotia
Study officials:
References: