CMSL Ambulatory Sensitive Condition Nudge Study 2

NCT ID: NCT07028398

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12990 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-29
• Study Completion Date: 2025-12-31

Brief Summary

The project aims to evaluate a nurse-led intervention to reduce inappropriate emergency department (ED) use among adult patients seen at Geisinger's Community Medicine Service Line (CMSL) clinics. The intervention occurs immediately following an appointment where a patient receives a diagnosis of an ambulatory sensitive condition (ASC; i.e., a condition considered to be a risk factor for near-term ED use). The evaluation will compare eligible patients with an ASC who were randomly assigned to receive follow-up outreach (patient portal message and/or call) from a nurse (who was automatically prompted via the Epic electronic health record system to initiate outreach) with those who were randomly assigned to receive standard care. Analyses will be intent-to-treat. The primary outcome is ED use in the week (i.e., 7 days) following the appointment.

We ran an earlier version of this intervention (NCT06798389). The current study is modified based on results and clinical guidance. Specifically, more conditions will be included as qualifying ASCs for enrollment. Patients under 30 will be excluded. And rather than calling all patients as in the original study, patient portal users may be contacted via the portal instead of or in addition to a phone call. Finally, in the first study, the intervention was differentially effective by age group (<45, 45-64, 65+). Our primary analysis will be conducted separately by age group, though we will also conduct an analysis combining across age groups.

We will run the study until we reach at least 4,330 patients in each of the following age groups: patients aged 30-45, patients aged 45-64, patients aged 65+. Therefore, our estimated sample size is at least 4,330x3 = 12,990.

We may be required to do an interim data pull and/or stop the study early at the direction of clinical or operational leaders.

Conditions

Behavioral Intervention; Emergency Department Visits; Nurse Care Coordination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Nurse Nudge

Nurses in CMSL clinics will receive a notification to provide follow-up outreach (calls and/or patient portal messages) to patients after the patient receives an ambulatory sensitive diagnosis.

Group Type: EXPERIMENTAL

Nurse Nudge

Intervention Type: BEHAVIORAL

Nurses will be nudged to contact patients, which may increase the likelihood that the patient receives a post- appointment follow-up call and/or portal message.

Control

Nurses in CMSL clinics will receive standard follow- up notifications, which may mean no notifications, after a patient has received an ambulatory sensitive diagnosis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse Nudge

Nurses will be nudged to contact patients, which may increase the likelihood that the patient receives a post- appointment follow-up call and/or portal message.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 30 years +
• Has a qualifying visit in CMSL with an ambulatory sensitive condition (ASC) encounter diagnosis

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amir Goren

Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Geisinger

Danville, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amir Goren, PhD

Role: CONTACT

agoren@geisinger.edu

570-214-3495

Facility Contacts

Amir Goren, PhD

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-1716-2

Identifier Type: -

Identifier Source: org_study_id