Emergency Department Discharge CommunicationED-PATCHNCT06668636
Examining the Effectiveness and Implementation of the Emergency Department Patient-Activated Transition to Care At Home Tool
A study testing ED-PATCH in people with Emergency Department Discharge Communication, run by IWK Health Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Emergency Department Discharge Communication
- What is being tested?
- ED-PATCH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Jan 2024to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
IWK Health
Halifax, Nova Scotia, B3K 6R8
Valley Regional Hospital
Kentville, Nova Scotia, B4N 5E3
About this study
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
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
Read more
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.
Read the 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.
- Being tested
- ED-PATCH
- Keywords
- emergency department, discharge communication, discharge instructions, mobile applications
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-PATCHBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation | No intervention | This arm of the study will occur before ED-PATCH has been implemented. Patients will receive usual discharge communication. |
| Post-Implementation | Experimental | This arm of the study will occur after ED-PATCH has been implemented. Receives: Behavioral: ED-PATCH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Rate of ED and Hospital Readmissions
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.
Measured: 7 days post-index visit
Secondary outcomes (7)
Patient-Reported Outcomes (PROM-ED)
The PROM-ED questionnaire will be used to measure patient-centered outcomes of importance during transitions in emergency care across four domains: symptom relief, understanding of their health concern, reassurance, and having a plan they can follow.
Measured: At baseline and 72 hours after discharge
Perceived Stress
Patients' perceived stress will be measured during the ED visit using the visual analogue scale (VAS) for stress, with which participants rate their stress level on a scale from 0 (no stress) to 10 (worst possible stress).
Measured: At baseline
Patient Experiences of Care Transitions (ED CAHPS)
Patient experiences of care transitions will be measured using the Emergency Department Consumer Assessment of Healthcare Providers and Systems (ED CAHPS) survey which includes 35 questions that focus on communication and coordination of care during the visit.
Measured: 72 hours after discharge
Recall and Comprehension Survey of Information Shared During the ED Visit
A survey created for the study will measure patient or caregiver's recall and comprehension of four key areas related to their care: 1. Diagnosis; 2. Procedures and diagnostic tests undertaken during the index visit; 3. Medication administered during their visit and medication prescribed on discharge; and 4. Details regarding follow-up. The survey responses will be corroborated with details about the ED visit from the patient chart.
Measured: 72 hours and 7 days after discharge
Health Care Utilization (Length of Stay, Return Visits, Hospital Admissions)
Hospital administrative databases will be used to calculate length of stay (total time from assessment in triage to discharge), ED return visits within 72 hours, ED return visits at 7 days, ED return visits at 30 days, and hospital admissions at 7 days.
Measured: 72 hours after discharge, 7 days after discharge, 30 days after discharge
Implementation Tracking
The Framework for Reporting Adaptations and Modifications-Enhanced Implementation Strategy (FRAME-IS) will guide tracking the nature of any modifications and adaptations to the implementation strategy, when they occurred, who participated in the decision to modify, and the reasons why the changes were made.
Measured: 18 months post-implementation
Patient and Provider Perceptions of Implementation
A semi-structured qualitative interview guide will be used to solicit patient and provider perspectives on how ED-PATCH was implemented.
Measured: Patient participants: 4 weeks post-discharge; Provider participants: 8 weeks after ITS closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start16 Jan 2024
- Primary completionJun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Department Discharge CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study will employ an interrupted time series design.
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Curran, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668636
- Sponsor's protocol ID
- IWK-REB-1030763
- Other IDs
- 190304
- Acronym
- ED-PATCH
- Status last verified
- Jan 2025
- First submitted
- 28 Oct 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified datasets generated during the proposed study may be made available on request to those with a methodologically sound proposal and pending ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06668636
- Acronym / sponsor ID
- ED-PATCH / IWK-REB-1030763
- Keywords
- emergency department, discharge communication, discharge instructions, mobile applications
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will employ an interrupted time series design.
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation | No intervention | –This arm of the study will occur before ED-PATCH has been implemented. Patients will receive usual discharge communication. |
| Post-Implementation | Experimental | Behavioral: ED-PATCHThis arm of the study will occur after ED-PATCH has been implemented. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED-PATCHParticipants 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. | Behavioural | Post-Implementation |
Primary outcome
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.
7 secondary outcomes
Patient-Reported Outcomes (PROM-ED)
Time frame: At baseline and 72 hours after discharge
Perceived Stress
Time frame: At baseline
Patient Experiences of Care Transitions (ED CAHPS)
Time frame: 72 hours after discharge
Recall and Comprehension Survey of Information Shared During the ED Visit
Time frame: 72 hours and 7 days after discharge
Health Care Utilization (Length of Stay, Return Visits, Hospital Admissions)
Time frame: 72 hours after discharge, 7 days after discharge, 30 days after discharge
Implementation Tracking
Time frame: 18 months post-implementation
Patient and Provider Perceptions of Implementation
Time frame: Patient participants: 4 weeks post-discharge; Provider participants: 8 weeks after ITS closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Yes. The de-identified datasets generated during the proposed study may be made available on request to those with a methodologically sound proposal and pending ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-PATCH in people with Emergency Department Discharge Communication, run by IWK Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Rate of ED and Hospital Readmissions (time frame: 7 days post-index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.