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Clinical Trials/NCT06668636
NCT06668636
Enrolling by Invitation
N/A

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

IWK Health Centre2 sites in 1 country12,000 target enrollmentJanuary 16, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
IWK Health Centre
Enrollment
12000
Locations
2
Primary Endpoint
Monthly Rate of ED and Hospital Readmissions
Status
Enrolling by Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2024
End Date
September 30, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Janet Curran

Quality and Patient Safety Research Chair

IWK Health Centre

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

Outcomes

Primary Outcomes

Monthly Rate of ED and Hospital Readmissions

Time Frame: 7 days post-index visit

Monthly rate of emergency department and hospital readmissions (composite) at 7 days post-index visit, per every 100 visits, assessed of all available visits at each site.

Secondary Outcomes

  • Patient-Reported Outcomes (PROM-ED)(At baseline and 72 hours after discharge)
  • Perceived Stress(At baseline)
  • Patient Experiences of Care Transitions (ED CAHPS)(72 hours after discharge)
  • Recall and Comprehension Survey of Information Shared During the ED Visit(72 hours and 7 days after discharge)
  • Health Care Utilization (Length of Stay, Return Visits, Hospital Admissions)(72 hours after discharge, 7 days after discharge, 30 days after discharge)
  • Implementation Tracking(18 months post-implementation)
  • Patient and Provider Perceptions of Implementation(Patient participants: 4 weeks post-discharge; Provider participants: 8 weeks after ITS closure)

Study Sites (2)

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