University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT07636187
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
A substantial portion of the United States population remains overdue for preventive care screenings, despite availability of health services. This gap in care persists due to both patient and clinician facing barriers. Patients may not always remain actively engaged with their care team, while clinicians are impacted by time constraints and the complexity of managing multiple care tasks during visits. One population health strategy to address these barriers is visit-based nudges, which is anchored around office visits and uses methods such as pre-visit texting to patients and pended orders for clinicians. In a previous study aimed at improving influenza vaccination rates, pre-visit texting and automated pended orders used within an office visit increased vaccination rates by 5 percentage points. Another prior study, aimed at improving mammogram completion, utilized pended orders and post-visit texting to increase screening rates by 5 percentage points at six months for intervention patients. Both studies have demonstrated the impact of leveraging multiple nudges to both patients and clinicians and have highlighted the need to integrate these aspects into one large scalable program to create a cohesive patient experience. Building upon our prior work and in collaboration with primary care, we propose to develop and evaluate an integrated visit-based preventive health program with nudges to both clinicians and patients using a stepped wedge design, with the goal of implementing this system across primary care practices.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients must meet the following criteria to be eligible:
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.
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.
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.
Time frame: Within 3 months after first eligible primary care visit.
The primary outcome is the proportion of patients overdue who complete Hepatitis C screening within 3 months after the first eligible primary care visit.
Time frame: Within 3 months after first eligible primary care visit.
The primary outcome is the proportion of patients overdue who complete lipids screening within 3 months after the first eligible primary care visit.
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.
Time frame: Within 3 months after the first eligible primary care visit.
The secondary outcome is the proportion of patients overdue who complete Hemoglobin A1C screening within 3 months after the first eligible primary care visit.
Time frame: Within 3 months after the first eligible primary care visit.
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.
Time frame: Within 3 months after the first eligible primary care visit.
The secondary outcome is the proportion of patients overdue who complete Urine Microalbumin screening within 3 months after the first eligible primary care visit.
Time frame: Within 6 months after the first eligible primary care visit.
The secondary outcome is the proportion of patients overdue who complete a mammogram within 6 months after the first eligible primary care visit.
Time frame: Within 6 months after the first eligible primary care visit.
The secondary outcome is the proportion of patients overdue who complete Hepatitis C screening within 6 months after the first eligible primary care visit.
Time frame: Within 6 months after the first eligible primary care visit.
The primary outcome is the proportion of patients overdue who complete lipids screening within 6 months after the first eligible primary care visit.
Time frame: Within 6 months after the first eligible primary care visit.
The secondary outcome is the proportion of patients overdue who complete DEXA screening within 6 months after the first eligible primary care visit.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Acronym: PROACTIVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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