Clinical trial NCT05724615: Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening (Missing Lipids)
Official title: Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerotic Cardiovascular Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SCREENING

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.

Detailed description: Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of mortality and disability in the United States. In order to prevent, predict and reduce ASCVD risk, clinicians will frequently use pool cohort equations (10 years CVD risk) to risk stratify patients and address modifiable risk factors. The American College of Cardiology/American Heart Association recommends routinely assessing traditional cardiovascular risk factors and calculation of 10-year ASCVD risk for adults 40 to 75 years of age and assessing traditional ASCVD risk factors for all adults 20 to 39 years of age at least every 4-6 years (Arnett et al., 2019 ). Among the components involved in the ASCVD risk stratification tool is a comprehensive lipid panel.

A mini-pilot on 100 patients overdue for lipid screening showed that bulk-ordering and text message concierge service (reminders and answering questions/concerns) increased response rate (21%) compared to conventional outreach (12%) or bulk-ordering only (9%). Qualitative analysis suggested that bulk-ordering as a default option reduces patient and clinician effort, and that uptake can benefit from trust enhancement (PCP endorsement), salience of communication (time-limited components, physical lab order), and effort/cognitive load reduction (text message reminders, scheduling assistance).

The aim is to conduct a pragmatic trial to evaluate the effect of bulk orders and text-based reminders on lipid screening rates among eligible patients who are overdue.H1: We hypothesize that reducing effort required from patients and clinicians through bulk ordering as a default with a reminder will result in greater completion of lipid screening compared to usual care.H2: We hypothesize that reducing effort through bulk ordering and providing complementary communication modalities (text message reminders and scheduling assistance) will result in higher response rates compared to bulk order and usual care.The primary study endpoint is the completion of the lipid panel within 3 months. An additional endpoint includes the number of patients with an elevated ASCVD risk score and the number of patients that had a clinical change (i.e. statin prescription) due to this information. The primary hypotheses are that Outreach + Bulk ordering (arm 2) will increase completion of lipid panel compared to usual care (arm 1), and that Outreach + Bulk ordering + Text Based Reminders (arm 3) will increase completion of lipid panel compared to usual care (arm 1) or conventional outreach + bulk ordering (arm 2). The results of the trial will also provide data that can be used to design future interventions that test the use of various behavioral economics tools to incentivize completion of lab tests. Secondary outcomes include completion of the lipid panel within 6 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants that completed a lipid panel
timeFrame: 3 months from initial outreach
Secondary outcomes:
measure: Number of participants that completed a lipid panel in the follow up period
timeFrame: 6 months from initial outreach
measure: AVCSD risk score
timeFrame: 6 months
measure: Patients initiated on statins
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: