- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07636187
Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (PROACTIVE)
A substantial portion of the United States population remains overdue for key screenings, despite availability and insurance coverage of preventive health services. Barriers for completion and remaining up to date with screening include patients not remaining actively engaged with their care team, time constraints during office visits, and operational strain. This project aims to implement and evaluate a primary care visit-based program that harmonizes multiple preventive health and chronic disease management care gaps, reduces staff burden, and improves ordering and subsequent patient follow through on completion of overdue care gaps.
In this study, we will evaluate nudges to clinicians and patients to help increase screening completion for multiple care gaps identified as high priority by primary care, including imaging (Mammogram, DEXA) and labs (Diabetes Management (Hemoglobin A1C, Basic Metabolic Panel, and Urine Microalbumin), Hepatitis C, and Lipids). This will be a 6 month, stepped-wedge, pragmatic trial conducted at Penn Medicine.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shivan Mehta
- Phone Number: 215-898-9807
- Email: shivan.mehta@pennmedicine.upenn.edu
Study Contact Backup
- Name: Caitlin Brophy
- Email: Caitlin.Brophy@pennmedicine.upenn.edu
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System
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Contact:
- Caitlin Brophy
- Phone Number: 267-566-4956
- Email: caitlin.brophy@pennmedicine.upenn.edu
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Principal Investigator:
- Shivan Mehta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All patients must meet the following criteria to be eligible:
- 18 years or older
- A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
- Overdue for at least one of the included care gaps according to Health Maintenance: Mammogram, DEXA, Hemoglobin A1C, Basic Metabolic Panel, Urine Microalbumin, Lipids, Hepatitis C
- Last eligible office visit was greater than or equal to 3 months ago
Exclusion Criteria:
As this trial is integrated with routine clinical operations, there will be no exclusion criteria. However, for each care gap independently, we will exclude all patient visits throughout the remaining trial duration after the patient's first eligible office visit within the trial duration. In other words, each patient will contribute data from at most one eligible office visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Condition
During the control condition, clinics will receive standard of care.
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|
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Experimental: Active Intervention
During the active intervention, clinics will receive both clinician and patient facing nudges.
Patient nudges will be pre- and post-visit text message reminders about their overdue care gaps.
Clinician nudges will be default pended orders for overdue care gaps and an EHR Smart Data Element communication banner notifying the provider that a pre-visit reminder was sent to the patient and that orders have been pended for their review.
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The patient nudges will be delivered by a series of one to three text messages.
Patients will receive the pre-visit text message 2 days prior to their scheduled primary care visit.
This message will remind them that they are overdue for their preventive care imaging and/or labs and encourage them to speak with their provider about screening completion during their upcoming appointment.
All patients who complete their primary care visit and whose provider signed at least one of their pended orders will be sent post-visit text messages 7 and 14 days after completion, if they have not yet scheduled or completed their overdue labs and/or imaging.
The messages delivered at 7 and 14 days will remind patients that appointments for lab and imaging are available for them and provide phone number(s) to call for scheduling and a link to complete scheduling online.
Patients will also have the option to engage with a bi-directional support menu via text message.
The default pended orders will be automatically placed into the patient's primary care visit encounter via a custom Epic extension for each included care gap (mammogram, DEXA, hemoglobin A1C, basic metabolic panel, urine microalbumin, lipids, and Hepatitis C) that the patient is overdue for according to their Health Maintenance status.
Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.
An electronic health record (EHR) communication will be visible to the provider and entire care team during the visit encounter.
This smart data element (SDE) communication will display in the patient's EHR encounter as a section in pre-charting, check-in, and rooming, and will notify the clinician and care team that a pre-visit communication was sent to the patient regarding their overdue status for their preventive care imaging and/or labs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mammogram Screening Completion (3 months)
Time Frame: Within 3 months after first eligible primary care visit.
|
The primary outcome is the proportion of patients overdue who complete a mammogram within 3 months after the first eligible primary care visit.
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Within 3 months after first eligible primary care visit.
|
|
Hepatitis C Screening Completion (3 months)
Time Frame: Within 3 months after first eligible primary care visit.
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The primary outcome is the proportion of patients overdue who complete Hepatitis C screening within 3 months after the first eligible primary care visit.
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Within 3 months after first eligible primary care visit.
|
|
Lipids Screening Completion (3 months)
Time Frame: Within 3 months after first eligible primary care visit.
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The primary outcome is the proportion of patients overdue who complete lipids screening within 3 months after the first eligible primary care visit.
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Within 3 months after first eligible primary care visit.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DEXA Screening Completion (3 months)
Time Frame: Within 3 months after the first eligible primary care visit.
|
The secondary outcome is the proportion of patients overdue who complete DEXA screening within 3 months after the first eligible primary care visit.
|
Within 3 months after the first eligible primary care visit.
|
|
Hemoglobin A1C Screening Completion (3 months)
Time Frame: Within 3 months after the first eligible primary care visit.
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The secondary outcome is the proportion of patients overdue who complete Hemoglobin A1C screening within 3 months after the first eligible primary care visit.
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Within 3 months after the first eligible primary care visit.
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Basic Metabolic Panel Screening Completion (3 months)
Time Frame: Within 3 months after the first eligible primary care visit.
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The secondary outcome is the proportion of patients overdue who complete Basic Metabolic Panel screening within 3 months after the first eligible primary care visit.
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Within 3 months after the first eligible primary care visit.
|
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Urine Microalbumin Screening Completion (3 months)
Time Frame: Within 3 months after the first eligible primary care visit.
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The secondary outcome is the proportion of patients overdue who complete Urine Microalbumin screening within 3 months after the first eligible primary care visit.
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Within 3 months after the first eligible primary care visit.
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Mammogram Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
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The secondary outcome is the proportion of patients overdue who complete a mammogram within 6 months after the first eligible primary care visit.
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Within 6 months after the first eligible primary care visit.
|
|
Hepatitis C Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
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The secondary outcome is the proportion of patients overdue who complete Hepatitis C screening within 6 months after the first eligible primary care visit.
|
Within 6 months after the first eligible primary care visit.
|
|
Lipids Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
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The primary outcome is the proportion of patients overdue who complete lipids screening within 6 months after the first eligible primary care visit.
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Within 6 months after the first eligible primary care visit.
|
|
DEXA Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
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The secondary outcome is the proportion of patients overdue who complete DEXA screening within 6 months after the first eligible primary care visit.
|
Within 6 months after the first eligible primary care visit.
|
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Hemoglobin A1C Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
|
The secondary outcome is the proportion of patients overdue who complete Hemoglobin A1C screening within 6 months after the first eligible primary care visit.
|
Within 6 months after the first eligible primary care visit.
|
|
Basic Metabolic Panel Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
|
The secondary outcome is the proportion of patients overdue who complete Basic Metabolic Panel screening within 6 months after the first eligible primary care visit.
|
Within 6 months after the first eligible primary care visit.
|
|
Urine Microalbumin Screening Completion (6 months)
Time Frame: Within 6 months after the first eligible primary care visit.
|
The secondary outcome is the proportion of patients overdue who complete Urine Microalbumin screening within 6 months after the first eligible primary care visit.
|
Within 6 months after the first eligible primary care visit.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shivan Mehta, University of Pennsylvania
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
- 859571
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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