An interventional study of Outreach + Bulk ordering and Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance in Atherosclerotic Cardiovascular Disease, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Screening
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.
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.
4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,000 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive usual care only, and no additional intervention from this study.
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
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
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.
Number of participants that completed a lipid panel
Completion of lipid panel within 3 months across the 3 study arms.
Time frame: 3 months from initial outreach
Number of participants that completed a lipid panel in the follow up period
Completion of lipid panel within 6 months across the 3 study arms.
Time frame: 6 months from initial outreach
AVCSD risk score
Proportion of patients with ASCVD risk score \<5%(low risk), 5-7.5%(borderline risk), \>=7.5%-\<20% (intermediate risk) \>=20%(high risk)
Time frame: 6 months
Patients initiated on statins
Proportion of patients initiated on statins once score is calculated
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pennsylvania