Examining the Effectiveness and Implementation of the Emergency Department Patient-Activated Transition to Care At Home Tool

NCT ID: NCT06668636

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 12000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2028-09-30

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.

Conditions

Emergency Department Discharge Communication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pre-Implementation

This arm of the study will occur before ED-PATCH has been implemented. Patients will receive usual discharge communication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-Implementation

This arm of the study will occur after ED-PATCH has been implemented.

Group Type: EXPERIMENTAL

ED-PATCH

Intervention Type: BEHAVIORAL

Participants will access ED-PATCH using their personal mobile device and use it to track important information throughout their visit. The summary will be checked by a healthcare provider and corrected, if necessary, before being locked and sent to the patient or caregiver to keep for their own records.

Interventions

ED-PATCH

Participants will access ED-PATCH using their personal mobile device and use it to track important information throughout their visit. The summary will be checked by a healthcare provider and corrected, if necessary, before being locked and sent to the patient or caregiver to keep for their own records.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Janet Curran

Quality and Patient Safety Research Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IWK Health

Halifax, Nova Scotia, Canada

Valley Regional Hospital

Kentville, Nova Scotia, Canada

Countries

Canada

Other Identifiers

190304

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IWK-REB-1030763

Identifier Type: -

Identifier Source: org_study_id