Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening (Missing Lipids)

NCT05724615 | Completed

• 1 other identifier: 852867
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to evaluate different approaches to increase Lipid screenings among primary care patients at Penn Medicine. A randomized trial will test the effectiveness of bulk ordering, outreach via mailed letters, and text-based reminders with scheduling assistance for patients needing a lipids panel. We will observe the number of completed panels after 3 and 6 months.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants that completed a lipid panel

  Completion of lipid panel within 3 months across the 3 study arms.

  3 months from initial outreach

Secondary Outcomes (3)

• Number of participants that completed a lipid panel in the follow up period

  6 months from initial outreach

• AVCSD risk score

  6 months

• Patients initiated on statins

  6 months

Study Arms (3)

Usual care

NO INTERVENTION

Participants will receive usual care only, and no additional intervention from this study.

Outreach + Bulk ordering

EXPERIMENTAL

Participants will receive a standard mailed letter about lipid panel screening signed by Penn Primary Care, similar to birthday letters that are currently sent to some practices. These letters or messages will describe the importance of getting a lipid panel, their eligibility for a lipid panel, and information about fasting implications of getting the test. This letter will be complemented by a lipid panel order on behalf of their primary care provider, with a signed laboratory slip/order for lipid panel screening. Laboratory orders will be generated through bulk ordering in the electronic health records for all patients by a designated practice representative and the primary care provider as the authorizing clinician. Participants in Arm 2 will be asked to take the laboratory order to the laboratory of their choice to complete their test within the next 6 weeks.

Behavioral: Outreach + Bulk ordering

Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance

EXPERIMENTAL

Participants will receive a standard mailed letter, a signed laboratory slip/order, and text-based outreach. It will provide the patient information on walk-in hours in a partnering lab / or ask the patient to schedule an appointment with one of the listed Penn Labs with instructions on how to do so. Patients with an active MyPennMedicine account will be asked to schedule an appointment via MPM. Other patients will be sent a list with the contact of nearby available labs and opening hours and asked to call to schedule an appointment. Up to 2 reminder text messages with the deadline for the lab order will be sent to patients for which no appointment has been scheduled on MyPennMedicine at 2 weeks intervals. Enrollment in the text messaging platform will be opt-out. All results for lipid panel testing will be routed to the patients' primary care provider

Behavioral: Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance

Interventions

Outreach + Bulk ordering BEHAVIORAL

Participants will be sent an order for their lab screening and the recourse of the labs where they can schedule the screening.

Outreach + Bulk ordering

Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance BEHAVIORAL

Participants will be sent an order for their lab screening and the recourse of the labs where they can schedule the screening. They will also receive text messages to remind them to have their lab completed as well as a link to schedule the lab and inform them of walk-in hours.

Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are overdue for a lipid panel according to Health Maintenance in the EHR record (no lipid panel in the past 5 years or e those with diabetes or an annual lipid check modifier without a lipid panel for more than 1 year).
• Has PCP listed and at least 1 visit in last 3 years

You may not qualify if:

• Patients who do not have a cell phone listed in the EHR.
• Patients who have medical conditions that would significantly reduce likely benefit from lipid screening (metastatic cancer, hospice, palliative care).
• Preferred lab outside of Penn

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Pollak C, Parambath A, Coratti S, Norton L, Girard A, Reitz C, Snider CK, Xu L, Walker Z, John A, Putt ME, Volpp KG, Mehta SJ. Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening: A Randomized Clinical Trial. JAMA Cardiol. 2025 Apr 1;10(4):313-320. doi: 10.1001/jamacardio.2024.5281.

  PMID: 39879069 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shivan Mehta, MD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multilevel, pragmatic, 3-arm randomized clinical trial to assess completion of lipid panel testing. We will identify primary care patients eligible for lipid screening and randomize them in a 1:2:2 ratio to one of three arms during the intervention phase testing approaches requiring different degrees of p patient and clinician effort: Arm 1: Usual care Arm 2: Outreach + Bulk ordering Arm 3: Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 13, 2023
• Study Start: June 5, 2023
• Primary Completion: September 7, 2023
• Study Completion: December 7, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)