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Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (PROACTIVE)

30. Juli 2026 aktualisiert von: Shivan J Mehta, University of Pennsylvania

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, the investigators 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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 this prior work and in collaboration with primary care, the investigators 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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

16416

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania Health System

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

All patients must meet the following criteria to be eligible:

  1. 18 years or older
  2. A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
  3. 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
  4. 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control Condition
During the control condition, clinics will receive standard of care.
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.
Verhalten: Pre-visit and post-visit patient messaging
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.
Verhalten: Default pended order
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.
Verhalten: EHR communication
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mammogram Screening Completion (3 months)
Zeitfenster: 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.
Within 3 months after first eligible primary care visit.
Hepatitis C Screening Completion (3 months)
Zeitfenster: 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.
Within 3 months after first eligible primary care visit.
Lipids Screening Completion (3 months)
Zeitfenster: 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.
Within 3 months after first eligible primary care visit.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
DEXA Screening Completion (3 months)
Zeitfenster: 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)
Zeitfenster: 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.
Within 3 months after the first eligible primary care visit.
Basic Metabolic Panel Screening Completion (3 months)
Zeitfenster: 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.
Within 3 months after the first eligible primary care visit.
Urine Microalbumin Screening Completion (3 months)
Zeitfenster: 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.
Within 3 months after the first eligible primary care visit.
Mammogram Screening Completion (6 months)
Zeitfenster: 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.
Within 6 months after the first eligible primary care visit.
Hepatitis C Screening Completion (6 months)
Zeitfenster: 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.
Within 6 months after the first eligible primary care visit.
Lipids Screening Completion (6 months)
Zeitfenster: 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.
Within 6 months after the first eligible primary care visit.
DEXA Screening Completion (6 months)
Zeitfenster: 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.
Within 6 months after the first eligible primary care visit.
Hemoglobin A1C Screening Completion (6 months)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pennsylvania

Ermittler

  • Hauptermittler: Shivan Mehta, UNIVERSITY of PENNSYLVANIA

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Juli 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 859571

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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