- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955468
Evaluating a Bidirectional Priming Intervention for Goals-of-care Communication in Oncology (Prime GOC)
Development of a Bidirectional Priming Intervention for Goals-of-care Communication in Oncology
This pilot study will evaluate whether an intervention aimed at hospitalized patients with advanced lung and gastrointestinal cancers can help facilitate goals-of-care (GOC) communication with their oncologists after discharge.
While GOC communication is a recommended component of routine oncology care, many patients with solid cancers do not have the opportunity to talk with their oncologist about their goals and end-of-life preferences. Prior research has shown that a systematic method of prompting GOC communication with at-risk patients would address a key barrier to timely GOC communication and ensure that patients receive care that is in line with their personal preferences.
This trial will enroll 80 participants, who will be randomized 1:1 to either an intervention or a control group. Participants in the intervention group will complete a short survey regarding their goals, preferences, and disease understanding. Survey responses will be shared with each participant's outpatient oncology team. Oncologists will subsequently receive a nudge in the electronic medical record reminding them of key survey responses and encouraging them to discuss them at the patient's first clinic visit after hospital discharge.
The primary feasibility outcome is intervention completion rate and the primary clinical outcome is GOC documentation within 30 days of discharge in the intervention group compared to the control group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Unplanned admission to the HUP Solid Oncology service;
- Underlying diagnosis of advanced lung or GI cancer, defined as metastatic or locally advanced disease;
- Anticipated discharge within the next 72h; and
- Primary oncologist is based at HUP; or
- Family member/caregiver of a patient meeting the above 4 criteria.
Exclusion Criteria:
1. Unable to complete survey in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Intervention
Participants in the intervention arm will complete a survey prior to hospital discharge.
Their responses will be shared with each participant's outpatient oncology team.
|
13-item priming survey assessing patients' goals, treatment preferences, and disease understanding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Completion Rate
Time Frame: From enrollment to 30 days after hospital discharge
|
The primary feasibility outcome is intervention completion rate, defined as successful completion of the survey, response sharing, and electronic medical record nudge for all participants assigned to the intervention arm.
|
From enrollment to 30 days after hospital discharge
|
|
GOC Documentation
Time Frame: From enrollment to 30 days after hospital discharge
|
The presence of outpatient goals-of-care documentation in the electronic medical record within 30 days of hospital discharge as determined by manual review.
|
From enrollment to 30 days after hospital discharge
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 26924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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