- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550192
Oncology Acute Care Follow-up Intervention Study
A Pragmatic Randomized Controlled Crossover Study to Evaluate the Impact of Messaging Interventions on Emergency Department Utilization Among Oncology Patients at Parkland Health
This pragmatic randomized controlled study evaluates an education intervention designed to increase patient engagement with Oncology Acute Care (OAC) services among patients being treated for cancer at Parkland Health.
Eligible patients will be randomized to either a control (usual care) arm or an intervention arm. If a patient in the control group has experiences a subsequent cancer treatment related ED visit without documented OAC engagement, they will be moved to the intervention arm. Patients in the intervention arm will receive an automated MyChart message and text message within 24 hours of hospital discharge reinforcing oncology acute care (OAC) resources, including contact information for the triage line and guidance for when to seek urgent versus emergency care. Messages will be resent at 48 and 72 hours if unviewed. Once the message is viewed, the patient will enter an outcome tracking period to monitor time to subsequent ED visit or OAC contact. Follow-up will occur in 3-month intervals until an outcome is documented or the study ends.
After randomization, patients will be monitored on an observation list for outcomes including OAC contact and cancer treatment-related Emergency Department (ED) visits. Patients who contact OAC clinic will be removed from observation list and complete the study. We will repeat the observation period and document outcomes if the patient has a subsequent cancer treatment-related ED visits without documented OAC engagement.
Study Overview
Detailed Description
Overview:
This study is a pragmatic randomized controlled crossover trial designed to evaluate the feasibility and impact of structured follow-up messaging interventions on patient engagement with Oncology Acute Care (OAC) services and reduction in cancer treatment-related Emergency Department (ED) visits at Parkland Health.
Recruitment and Enrollment:
Eligible patients will be identified using an automated dashboard through Parkland's Epic electronic health record system based on the inclusion/Exclusion criteria. Patients meeting criteria will be automatically flagged for study enrollment. No active consent will be required as the intervention involves standard communication methods already available to patients (MyChart and text messaging), and the study poses minimal risk.
Randomization and Crossover Design:
Patients will be randomized into one of two arms:
Control Arm (Usual Care): Patients receive standard hospital discharge instructions without additional messaging.
Intervention Arm: Patients receive structured follow-up messages using existing education materials via MyChart and automated text messaging within 24, 48, and 72 hours post-discharge. Patients in the control arm who experience a subsequent cancer treatment related ED visit without documented OAC engagement will be crossed over to the intervention arm.
Messaging Intervention:
Patients randomized to the intervention arm will receive structured follow-up messages aimed at increasing awareness and utilization of Oncology Acute Care (OAC) services. Messaging will be delivered via both MyChart and automated text messages, tailored to the patient's preferred language (English or Spanish).
Initial Message: Sent within 24 hours post discharge from the ED observation, or inpatient stay (10AM following discharge). This message will include:
- Contact information for the OAC clinic and triage line
- Guidance on when to seek urgent care through OAC versus emergency care, including a reminder that same-day OAC appointments may be available
- Follow-Up Messages: If the initial message is not viewed, it will be resent at 48 hours and again at 72 hours post-discharge. Up to 3 messages will be sent per discharge.
- Message Engagement Tracking: Once a message is viewed, the patient enters an outcome tracking period. The study team will record engagement metrics on whether messages were viewed to assess implementation fidelity.
Outcome Tracking:
The study team will monitor patient medical records for the following:
- Time to next cancer treatment-related ED arrivals (including observation and inpatient admissions)
- Contact with OAC clinic or triage line
- Total hospital visits
Follow-up will occur in 3-month intervals. Patients who engage with the OAC clinic will be removed from the observation list and considered to have completed the study. If a patient has another ED visit without OAC engagement, the observation period will repeat.
Data Collection:
Data will be extracted from Epic and include:
- Message engagement metrics (viewed/unviewed, response rates)
- OAC contact logs
- ED visit records
- Patient demographics and clinical characteristics
Data Analysis Plan:
Descriptive statistics will be used to summarize engagement and outcome data. Time-to event analyses (Kaplan-Meier curves with Cox proportional hazards models) will be used to compare time to ED arrival between arms. Mixed-effects logistic regression will be used to analyze secondary visit county outcomes. Subgroup analyses will explore differential effects by language, cancer type, and prior ED utilization.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arthur Hong, MD, MPH
- Phone Number: 214-648-3240
- Email: Arthur.Hong@utsouthwestern.edu
Study Contact Backup
- Name: Kathryn Anderson, MA
- Phone Number: 214-648-6357
- Email: Kathryn.Anderson@utsouthwestern.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Parkland Health
-
Contact:
- Kathryn Anderson, MA
- Phone Number: 214-648-6357
- Email: Kathryn.Anderson@utsouthwestern.edu
-
Contact:
- Arthur Hong, MD
- Phone Number: 214-648-3240
- Email: Arthur.Hong@utsouthwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Active cancer diagnosis
- Actively receiving chemotherapy treatment
- ED Arrival within 30 days of chemotherapy treatment
- Discharged home following ED visit, observation, or inpatient stay
- Enrolled in MyChart with valid mobile number and language preference recorded (English or Spanish)
Exclusion Criteria:
- Not enrolled in MyChart or lacking a valid mobile phone number.
- Language preference not recorded or not English/Spanish (if messaging is only available in these languages).
- Receiving hospice or palliative care services, where acute symptom management goals may differ.
- Patients admitted directly to inpatient care without ED visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Arm (Usual Care)
Patients receive standard hospital discharge instructions without additional messaging Patients in the control arm who experience a subsequent cancer treatment-related ED visit without documented OAC engagement will be crossed over to the intervention arm.
|
|
|
Experimental: Intervention Arm
Patients receive structured follow-up messages using existing education materials via MyChart and automated text messaging within 24, 48, and 72 hours post-discharge.
|
Patients randomized to the intervention arm will receive structured follow-up messages aimed at increasing awareness and utilization of Oncology Acute Care (OAC) services.
Messaging will be delivered via both MyChart and automated text messages, tailored to the patient's preferred language (English or Spanish).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the next cancer treatment related ED visit.
Time Frame: 2 years maximum
|
Evaluate whether structured MyChart + text messaging after hospital/ED discharge decreases time to the next cancer treatment-related ED visit compared with usual care.
|
2 years maximum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Engagement with OAC
Time Frame: 2 years maximum
|
Assess whether messaging increases patient engagement with the Oncology Acute Care triage line or clinic before returning to the ED.
|
2 years maximum
|
|
Message Engagement
Time Frame: 2 years maximum
|
Measure message engagement metrics (viewed, unviewed, and response rates).
|
2 years maximum
|
|
Evaluate Feasibility
Time Frame: 2 years maximum
|
Evaluate feasibility and implementation fidelity of the messaging workflow within Parkland's Epic environment.
|
2 years maximum
|
|
Identify Patient Subgroups
Time Frame: 2 years maximum
|
Identify patient subgroups (e.g., language, cancer type, prior ED utilization) where the intervention has the greatest effect on ED utilization or care engagement.
|
2 years maximum
|
Collaborators and Investigators
Investigators
- Principal Investigator: Arthur Hong, MD, MPH, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU20251326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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