Behavior, HealthPROACTIVENCT07636187
Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters
A study testing Pre-visit and post-visit patient messaging, Default pended order and EHR communication in people with Behavior, Health, run by University of Pennsylvania at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Pre-visit and post-visit patient messaging, Default pended order and EHR communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,416 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
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.
- Conditions
- Behavior, Health
- Being tested
- Pre-visit and post-visit patient messaging, Default pended order, EHR communication
- Keywords
- EHR Nudge, Behavioral Economics, Preventive Health
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-visit and post-visit patient messagingBehavioural
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.
Default pended orderBehavioural
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.
EHR communicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | During the control condition, clinics will receive standard of care. |
| Active Intervention | Experimental | 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. Receives: Behavioral: Pre-visit and post-visit patient messaging; Behavioral: Default pended order; Behavioral: EHR communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram Screening Completion (3 months)
The primary outcome is the proportion of patients overdue who complete a mammogram within 3 months after the first eligible primary care visit.
Measured: Within 3 months after first eligible primary care visit.
Hepatitis C Screening Completion (3 months)
The primary outcome is the proportion of patients overdue who complete Hepatitis C screening within 3 months after the first eligible primary care visit.
Measured: Within 3 months after first eligible primary care visit.
Lipids Screening Completion (3 months)
The primary outcome is the proportion of patients overdue who complete lipids screening within 3 months after the first eligible primary care visit.
Measured: Within 3 months after first eligible primary care visit.
Secondary outcomes (11)
DEXA Screening Completion (3 months)
The secondary outcome is the proportion of patients overdue who complete DEXA screening within 3 months after the first eligible primary care visit.
Measured: Within 3 months after the first eligible primary care visit.
Hemoglobin A1C Screening Completion (3 months)
The secondary outcome is the proportion of patients overdue who complete Hemoglobin A1C screening within 3 months after the first eligible primary care visit.
Measured: Within 3 months after the first eligible primary care visit.
Basic Metabolic Panel Screening Completion (3 months)
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.
Measured: Within 3 months after the first eligible primary care visit.
Urine Microalbumin Screening Completion (3 months)
The secondary outcome is the proportion of patients overdue who complete Urine Microalbumin screening within 3 months after the first eligible primary care visit.
Measured: Within 3 months after the first eligible primary care visit.
Mammogram Screening Completion (6 months)
The secondary outcome is the proportion of patients overdue who complete a mammogram within 6 months after the first eligible primary care visit.
Measured: Within 6 months after the first eligible primary care visit.
Hepatitis C Screening Completion (6 months)
The secondary outcome is the proportion of patients overdue who complete Hepatitis C screening within 6 months after the first eligible primary care visit.
Measured: Within 6 months after the first eligible primary care visit.
Lipids Screening Completion (6 months)
The primary outcome is the proportion of patients overdue who complete lipids screening within 6 months after the first eligible primary care visit.
Measured: Within 6 months after the first eligible primary care visit.
DEXA Screening Completion (6 months)
The secondary outcome is the proportion of patients overdue who complete DEXA screening within 6 months after the first eligible primary care visit.
Measured: Within 6 months after the first eligible primary care visit.
Hemoglobin A1C Screening Completion (6 months)
The secondary outcome is the proportion of patients overdue who complete Hemoglobin A1C screening within 6 months after the first eligible primary care visit.
Measured: Within 6 months after the first eligible primary care visit.
Basic Metabolic Panel Screening Completion (6 months)
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.
Measured: Within 6 months after the first eligible primary care visit.
Urine Microalbumin Screening Completion (6 months)
The secondary outcome is the proportion of patients overdue who complete Urine Microalbumin screening within 6 months after the first eligible primary care visit.
Measured: Within 6 months after the first eligible primary care visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start28 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In a cluster randomized stepped wedge design, units are randomized to a particular time period at which to switch from the control condition to the active intervention. After the intervention is activated by a unit (e.g., a clinic), it remains active throughout the remainder of the trial. The first period serves as a baseline with all clinics following the control condition. In the last period of the trial, all clinics are implementing the active intervention. PROACTIVE will consist of six 4-week periods including the baseline period (i.e., the control condition). Prior to study launch, 24 participating clinics will be randomized to one of the remaining five periods (i.e., periods 2 through 6). The randomization will be stratified by clinic type, defined as community (employed by health system) or academic (part of medical school department).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16,416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
- Investigators
- Shivan Mehta, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636187
- Sponsor's protocol ID
- 859571
- Acronym
- PROACTIVE
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters
- ClinicalTrials.gov ID
- NCT07636187
- Acronym / sponsor ID
- PROACTIVE / 859571
- Conditions
- Behavior, Health
- Keywords
- EHR Nudge, Behavioral Economics, Preventive Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 16,416 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In a cluster randomized stepped wedge design, units are randomized to a particular time period at which to switch from the control condition to the active intervention. After the intervention is activated by a unit (e.g., a clinic), it remains active throughout the remainder of the trial. The first period serves as a baseline with all clinics following the control condition. In the last period of the trial, all clinics are implementing the active intervention. PROACTIVE will consist of six 4-week periods including the baseline period (i.e., the control condition). Prior to study launch, 24 participating clinics will be randomized to one of the remaining five periods (i.e., periods 2 through 6). The randomization will be stratified by clinic type, defined as community (employed by health system) or academic (part of medical school department).
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –During the control condition, clinics will receive standard of care. |
| Active Intervention | Experimental | Behavioral: Pre-visit and post-visit patient messaging, Behavioral: Default pended order, Behavioral: EHR communicationDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-visit and post-visit patient messagingThe 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. | Behavioural | Active Intervention |
| Default pended orderThe 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. | Behavioural | Active Intervention |
| EHR communicationAn 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. | Behavioural | Active Intervention |
Primary outcome
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.
Hepatitis C 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 Hepatitis C screening within 3 months after the first eligible primary care visit.
Lipids 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 lipids screening within 3 months after the first eligible primary care visit.
11 secondary outcomes
DEXA Screening Completion (3 months)
Time frame: 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.
Basic Metabolic Panel Screening Completion (3 months)
Time frame: Within 3 months after the first eligible primary care visit.
Urine Microalbumin Screening Completion (3 months)
Time frame: Within 3 months after the first eligible primary care visit.
Mammogram Screening Completion (6 months)
Time frame: 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.
Lipids Screening Completion (6 months)
Time frame: 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.
Hemoglobin A1C Screening Completion (6 months)
Time frame: 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.
Urine Microalbumin Screening Completion (6 months)
Time frame: Within 6 months after the first eligible primary care visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Behavior, Health
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shivan Mehta principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-visit and post-visit patient messaging, Default pended order and EHR communication in people with Behavior, Health, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammogram Screening Completion (3 months) (time frame: Within 3 months after first eligible primary care visit.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.