Atherosclerotic Cardiovascular DiseaseNCT05724615
Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening (Missing Lipids)
A study testing Outreach + Bulk ordering and Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance in people with Atherosclerotic Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Outreach + Bulk ordering and Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid 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.
Read the 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.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Outreach + Bulk ordering, Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach + Bulk orderingBehavioural
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 + Text Based Reminders and Scheduling assistanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that completed a lipid panel
Completion of lipid panel within 3 months across the 3 study arms.
Measured: 3 months from initial outreach
Secondary outcomes (3)
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.
Measured: 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)
Measured: 6 months
Patients initiated on statins
Proportion of patients initiated on statins once score is calculated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start5 Jun 2023
- Primary completion7 Sep 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivan Mehta, MD, MBA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724615
- Sponsor's protocol ID
- 852867
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39879069
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Default Bulk Ordering and Text Messaging to Enhance Outreach for Lipid Screening
- ClinicalTrials.gov ID
- NCT05724615
- Acronym / sponsor ID
- 852867
- Conditions
- Atherosclerotic Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants will receive usual care only, and no additional intervention from this study. |
| Outreach + Bulk ordering | Experimental | Behavioral: Outreach + Bulk orderingParticipants 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. |
| Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance | Experimental | Behavioral: Outreach + Bulk ordering + Text Based Reminders and Scheduling assistanceParticipants 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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outreach + Bulk orderingParticipants will be sent an order for their lab screening and the recourse of the labs where they can schedule the screening. | Behavioural | Outreach + Bulk ordering |
| Outreach + Bulk ordering + Text Based Reminders and Scheduling assistanceParticipants 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. | Behavioural | Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance |
Primary outcome
Number of participants that completed a lipid panel
Time frame: 3 months from initial outreach
Completion of lipid panel within 3 months across the 3 study arms.
3 secondary outcomes
Number of participants that completed a lipid panel in the follow up period
Time frame: 6 months from initial outreach
AVCSD risk score
Time frame: 6 months
Patients initiated on statins
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 39879069Pollak 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.
- Individual participant dataSharing planned: No
Related trials for Atherosclerotic Cardiovascular Disease
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Active, not recruitingPhase 3
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Atherosclerotic Cardiovascular Disease, Overweight
Active, not recruitingObservational study
A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Spain)
Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shivan Mehta, MD, MBA principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach + Bulk ordering and Outreach + Bulk ordering + Text Based Reminders and Scheduling assistance in people with Atherosclerotic Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that completed a lipid panel (time frame: 3 months from initial outreach). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.