HyperlipidemiasNCT05537064
Centralized Prescribing for Statins
A study testing Non-visit Based Intervention and Visit-Based Intervention in people with Hyperlipidemias, run by University of Pennsylvania at 1 site in United States.
Trial summary
This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Non-visit Based Intervention and Visit-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,950 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Care Providers with at least 10 patients among their entire panel who meet the following criteria:
- Have a LGH PCP, AND
- 21-75 years old, AND
- An indication for high- or moderate-intensity statin, AND
- Pooled cohort risk equation 10-year ASCVD risk greater than 10%, OR
- diabetes mellitus, OR
Show all 10Show fewer
- very high LDL-C > 190 mg/dL, OR
- familial hyperlipidemia, OR
- established ASCVD,
- Not currently on statin therapy, OR on low dose-statin therapy
Who cannot join
- Have an allergy to statins
- Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
- Adverse reaction to statins including statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
- Pregnant
- Currently breastfeeding
- On hospice or at the end-of-life
- On a PCSK9 Inhibitor medication
- Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
About this study
Official title: A Pilot Study of Strategies to Increase Use of Centralized Pharmacy Services for Management of Statin Therapy Among Patients With or at High Risk for Atherosclerotic Vascular Disease
This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care.
Read the detailed description
This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care.
For trial #1, the investigators will identify PCPs at a single practice with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. These physicians will be randomized in stepped-wedge fashion to usual care or to a nudge, delivered at the time of a scheduled office visit, to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. In trial #2, the investigators will identify PCPs at 12 practices with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. Practices will be randomized to usual care or to a non-visit-based nudge to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. It is estimated that 13 practices and 83 providers will be eligible to participate in the two trials. The invesitgators will run the intervention over a 9-month time frame.
The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe. Secondary outcomes will include the prescription of guideline-directed intensity of statin medications as well as statin pharmacy dispense rate. The investigators will also assess LDL control over the study period.
- Conditions
- Hyperlipidemias
- Being tested
- Non-visit Based Intervention, Visit-Based Intervention
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-visit Based InterventionBehavioural
At the beginning of the study period, PCPs will be sent an Inbasket message, a secure electronic messaging system included in EPIC, similar to an email. The message will notify them that pended orders for a referral to centralized pharmacy services for statin management will be entered for eligible patients unless the provider opts out. If no opt-out is received from the PCP within 7 days of receiving the message, their eligible patient panels will be referred to a centralized pharmacy team to begin pending referral orders to the PCP for eligible patients. Pharmacists affiliated with the centralized pharmacy service will then enter pended orders for referral to centralized pharmacy services that PCPs can sign either individually or in bulk. After the PCP signs the order for referral to centralized pharmacy services, a pharmacist from the centralized pharmacy team will then reach out to the patient on behalf of their PCP and discuss their indication for statin therapy.
Visit-Based InterventionBehavioural
The study team will build an interruptive BestPractice advisory (BPA), a pop-up notification in the EHR that is delivered to the PCP when they open the patient's chart during a non-acute patient visit. The BestPractice Advisory will describe the guideline criteria for which the patient is eligible for statin therapy, and recommend referral to a centralized pharmacy service for statin initiation and management. It will also include a link to a menu for prescribing an appropriate-dose statin, should the PCP want to prescribe a statin without referral to pharmacy services. The option for ordering referral to centralized pharmacy services will be pre-selected, such that if the PCP simply clicks "Accept" on the BPA, an order for referral to centralized pharmacy services for statin initiation and management will be generated.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control arm exposed only to usual care, which consists of the passive decision support functionality Health Maintenance flag that is the current decision-support tool in the EMR. |
| Non-visit Based Intervention | Experimental | In this arm the investigators will evaluate a non-visit-based nudge to refer patients eligible for but not prescribed high-intensity statins to centralized pharmacy services for initiation and/or titration of a statin. Practices will be randomized to usual care versus the non-visit-based nudge. The non-visit-based nudge will consist of an EPIC In-basket message sent to each provider that identifies their patients eligible for but not prescribed high- or moderate-intensity statins and notifies them that pended orders for a referral to centralized pharmacy services for statin management will be entered for these patients unless the provider opts out. At the time the in-basket message is sent out, PCPs will also have the opportunity to opt out of participating in the trial entirely. Receives: Behavioral: Non-visit Based Intervention |
| Visit-Based Intervention | Experimental | In this arm the investigators will evaluate a visit-based nudge to refer to centralized pharmacy services to refer patients eligible for but not prescribed high-intensity statins to centralized pharmacy services for initiation and/or titration of a statin. Physicians in a single practice will be randomized to usual care versus visit-based nudge. The visit-based nudge will consist of an interruptive Best Practice Advisory (BPA) in the EMR that will trigger during non-acute patient visits and will prompt the provider to refer the patient to a centralized pharmacy service for statin initiation and management. Receives: Behavioral: Visit-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Prescribed a Statin (population level)
The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe, assessed among all patients assigned to the physician or office eligible for but not prescribed a high-intensity statin at the start of the trial. The primary outcome will be compared between patients seeing physicians, or seen at practices, randomized to the intervention vs. usual care.
Measured: 9 months
Number of Participants Prescribed a Statin (office-visit level)
The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe, assessed among all patients who had an office visit during the study period and were eligible for but not prescribed a high-intensity statin at the start of the trial. The primary outcome will be compared between patients seeing physicians, or seen at practices, randomized to the intervention vs. usual care.
Measured: 9 months
Secondary outcomes (1)
Statin Pharmacy Dispense Rate
Secondary outcomes will include the prescription of guideline-directed intensity of statin medications as well as statin pharmacy dispense rate. We will compare the proportion of eligible patients prescribed a guideline-concordant-intensity statin and the proportion filling a prescription for statin between patients seeing physicians randomized to intervention vs. usual care. This analysis will be performed both on the population-level (all patients assigned to the practice or physician eligible for but not prescribed a high-intensity statin at the start of the trial) and among patients with an office visit during the study period.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start2 Nov 2022
- Primary completion13 Jun 2023
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Fanaroff, MD, MHS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537064
- Sponsor's protocol ID
- 851668
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fanaroff AC, Huang Q, Clark K, Norton LA, Kellum WE, Eichelberger D, Wood JC, Bricker Z, Dooley Wood AG, Kemmer G, Smith JI, Adusumalli S, Putt ME, Volpp KG. Encouraging Pharmacist Referrals for Evidence-Based Statin Initiation: Two Cluster Randomized Clinical Trials. JAMA Cardiol. 2025 May 1;10(5):473-481. doi: 10.1001/jamacardio.2025.0244.
PubMed 40136263Fanaroff AC, Huang Q, Clark K, Norton LA, Kellum WE, Eichelberger D, Wood JC, Bricker Z, Wood AGD, Kemmer G, Smith JI, Adusumalli S, Putt M, Volpp KGM. Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: Rationale and design of the SUPER LIPID program. Am Heart J. 2024 Jul;273:83-89. doi: 10.1016/j.ahj.2024.04.013. Epub 2024 Apr 26.
PubMed 38679189
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Strategies to Increase Use of Centralized Pharmacy Services for Management of Statin Therapy Among Patients With or at High Risk for Atherosclerotic Vascular Disease
- ClinicalTrials.gov ID
- NCT05537064
- Acronym / sponsor ID
- 851668
- Conditions
- Hyperlipidemias
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,950 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Sep 2022 (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.
This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care.
Detailed description
This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care.
For trial #1, the investigators will identify PCPs at a single practice with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. These physicians will be randomized in stepped-wedge fashion to usual care or to a nudge, delivered at the time of a scheduled office visit, to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. In trial #2, the investigators will identify PCPs at 12 practices with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. Practices will be randomized to usual care or to a non-visit-based nudge to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. It is estimated that 13 practices and 83 providers will be eligible to participate in the two trials. The invesitgators will run the intervention over a 9-month time frame.
The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe. Secondary outcomes will include the prescription of guideline-directed intensity of statin medications as well as statin pharmacy dispense rate. The investigators will also assess LDL control over the study period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control arm exposed only to usual care, which consists of the passive decision support functionality Health Maintenance flag that is the current decision-support tool in the EMR. |
| Non-visit Based Intervention | Experimental | Behavioral: Non-visit Based InterventionIn this arm the investigators will evaluate a non-visit-based nudge to refer patients eligible for but not prescribed high-intensity statins to centralized pharmacy services for initiation and/or titration of a statin. Practices will be randomized to usual care versus the non-visit-based nudge. The non-visit-based nudge will consist of an EPIC In-basket message sent to each provider that identifies their patients eligible for but not prescribed high- or moderate-intensity statins and notifies them that pended orders for a referral to centralized pharmacy services for statin management will be entered for these patients unless the provider opts out. At the time the in-basket message is sent out, PCPs will also have the opportunity to opt out of participating in the trial entirely. |
| Visit-Based Intervention | Experimental | Behavioral: Visit-Based InterventionIn this arm the investigators will evaluate a visit-based nudge to refer to centralized pharmacy services to refer patients eligible for but not prescribed high-intensity statins to centralized pharmacy services for initiation and/or titration of a statin. Physicians in a single practice will be randomized to usual care versus visit-based nudge. The visit-based nudge will consist of an interruptive Best Practice Advisory (BPA) in the EMR that will trigger during non-acute patient visits and will prompt the provider to refer the patient to a centralized pharmacy service for statin initiation and management. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary Care Providers with at least 10 patients among their entire panel who meet the following criteria:
- Have a LGH PCP, AND
- 21-75 years old, AND
- An indication for high- or moderate-intensity statin, AND
- Not currently on statin therapy, OR on low dose-statin therapy
Key exclusion criteria (8 listed)
- Have an allergy to statins
- Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
- Adverse reaction to statins including statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
- Pregnant
- Currently breastfeeding
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 |
|---|---|---|
| Non-visit Based InterventionAt the beginning of the study period, PCPs will be sent an Inbasket message, a secure electronic messaging system included in EPIC, similar to an email. The message will notify them that pended orders for a referral to centralized pharmacy services for statin management will be entered for eligible patients unless the provider opts out. If no opt-out is received from the PCP within 7 days of receiving the message, their eligible patient panels will be referred to a centralized pharmacy team to begin pending referral orders to the PCP for eligible patients. Pharmacists affiliated with the centralized pharmacy service will then enter pended orders for referral to centralized pharmacy services that PCPs can sign either individually or in bulk. After the PCP signs the order for referral to centralized pharmacy services, a pharmacist from the centralized pharmacy team will then reach out to the patient on behalf of their PCP and discuss their indication for statin therapy. | Behavioural | Non-visit Based Intervention |
| Visit-Based InterventionThe study team will build an interruptive BestPractice advisory (BPA), a pop-up notification in the EHR that is delivered to the PCP when they open the patient's chart during a non-acute patient visit. The BestPractice Advisory will describe the guideline criteria for which the patient is eligible for statin therapy, and recommend referral to a centralized pharmacy service for statin initiation and management. It will also include a link to a menu for prescribing an appropriate-dose statin, should the PCP want to prescribe a statin without referral to pharmacy services. The option for ordering referral to centralized pharmacy services will be pre-selected, such that if the PCP simply clicks "Accept" on the BPA, an order for referral to centralized pharmacy services for statin initiation and management will be generated. | Behavioural | Visit-Based Intervention |
Primary outcome
Number of Participants Prescribed a Statin (population level)
Time frame: 9 months
The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe, assessed among all patients assigned to the physician or office eligible for but not prescribed a high-intensity statin at the start of the trial. The primary outcome will be compared between patients seeing physicians, or seen at practices, randomized to the intervention vs. usual care.
Number of Participants Prescribed a Statin (office-visit level)
Time frame: 9 months
The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe, assessed among all patients who had an office visit during the study period and were eligible for but not prescribed a high-intensity statin at the start of the trial. The primary outcome will be compared between patients seeing physicians, or seen at practices, randomized to the intervention vs. usual care.
1 secondary outcome
Statin Pharmacy Dispense Rate
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 40136263Fanaroff AC, Huang Q, Clark K, Norton LA, Kellum WE, Eichelberger D, Wood JC, Bricker Z, Dooley Wood AG, Kemmer G, Smith JI, Adusumalli S, Putt ME, Volpp KG. Encouraging Pharmacist Referrals for Evidence-Based Statin Initiation: Two Cluster Randomized Clinical Trials. JAMA Cardiol. 2025 May 1;10(5):473-481. doi: 10.1001/jamacardio.2025.0244.
- Derived from this study: PubMed 38679189Fanaroff AC, Huang Q, Clark K, Norton LA, Kellum WE, Eichelberger D, Wood JC, Bricker Z, Wood AGD, Kemmer G, Smith JI, Adusumalli S, Putt M, Volpp KGM. Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: Rationale and design of the SUPER LIPID program. Am Heart J. 2024 Jul;273:83-89. doi: 10.1016/j.ahj.2024.04.013. Epub 2024 Apr 26.
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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.
Alexander Fanaroff, MD, MHS 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 Non-visit Based Intervention and Visit-Based Intervention in people with Hyperlipidemias, 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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Prescribed a Statin (population level) (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT05537064, which also lists 2 linked publications.
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 6 Apr 2026.