Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening (Missing Lipids)
Condition: Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional

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.
    

Intervention name(s): Outreach + Bulk ordering; Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be sent an order for their lab screening and the recourse of the labs where they can schedule the screening.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening