Implementation Strategy Bundle for Lipid Disorders

(DONATE-FH Trial)

Overseen By Lakeisha Cade

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Cholesterol medications, Statin interactors

Disqualifiers: Pregnancy, Chronic liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cholesterol treatment management for individuals with familial hypercholesterolemia (FH), a condition that causes high cholesterol levels. Participants will be divided into two groups: one will receive the usual care, while the other will receive additional educational materials about managing high cholesterol as part of the Implementation Strategy Bundle. This approach seeks to determine if educational support can better assist those with FH. It is suitable for blood donors with high cholesterol who are not currently on cholesterol-lowering medication. As an unphased trial, this study offers participants the chance to contribute to innovative strategies that could enhance cholesterol management for many.

Will I have to stop taking my current medications?

If you are currently taking medication to lower cholesterol or any medication that can interact with statins, you cannot participate in this trial.

What prior data suggests that this Implementation Strategy Bundle is safe for improving cholesterol treatment?

Research shows that strategies like the Implementation Strategy Bundle aim to improve care for people with high cholesterol through education and organized methods. This approach helps patients better manage their cholesterol levels. Although detailed safety data for this specific bundle is not available, educational programs like this are generally considered low-risk. They provide materials and strategies to help people understand and control their cholesterol. This study is labeled "Not Applicable" for clinical trial phases, indicating a focus on improving care practices rather than testing a new drug or treatment, so major safety concerns are usually absent. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Implementation Strategy Bundle for lipid disorders because it offers a fresh approach to managing high cholesterol. Unlike standard care, which typically involves notifying patients about their cholesterol levels and advising them to consult with their primary care physician, this strategy adds an educational component. By providing patients with detailed educational materials about their condition, it empowers them to make informed decisions about their health. This proactive approach could lead to better patient engagement and improved long-term health outcomes, particularly for those who might not fully understand the implications of high cholesterol.

What evidence suggests that this trial's treatments could be effective for improving cholesterol treatment in blood donors with FH?

Research has shown that certain strategies can significantly help people manage high cholesterol, particularly in conditions like familial hypercholesterolemia (FH), a genetic disorder causing high cholesterol. In this trial, participants in the intervention group will receive an Implementation Strategy Bundle, which includes educational materials to help patients understand and address their health needs. Studies have found that these strategies ensure patients receive expert-recommended care. For those with FH, these methods focus on simplifying adherence to treatment guidelines. Early findings suggest that using these strategies can lead to better adherence to treatment plans and improved health outcomes. Meanwhile, the control group will receive usual care notifications, which are standard notifications typically provided to patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Amit Khera, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for blood donors aged 18 to 75 who have high cholesterol that fits the MEDPED criteria for Familial Hypercholesterolemia. It's not suitable for pregnant individuals, those with a secondary cause of high lipids, liver disease, or anyone already on cholesterol-lowering meds or drugs interacting with statins.

Inclusion Criteria

Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria

Exclusion Criteria

I am currently on medication to lower my cholesterol.

I am taking medication that interacts with statins.

My liver is not functioning properly or I have chronic liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either usual care or an implementation strategy bundle for cholesterol management

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 phone call, 1 virtual visit

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Strategy Bundle
• Usual care notification

Trial Overview The study aims to see if an 'Implementation Strategy Bundle' can better manage cholesterol in participants compared to just notifying them about their condition ('Usual care notification').

How Is the Trial Designed?

Group I: Intervention Group (Implementation strategy bundle) Experimental Treatment 2 Interventions

Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)

Group II: Control group (Usual care) Experimental Treatment 1 Intervention

This arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol

Implementation Strategy Bundle is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as NAFLD Care Bundle for:

• Non-Alcoholic Fatty Liver Disease (NAFLD) management

Approved in United States as Cholesterol Management Change Package for:

• Hyperlipidemia management
• Familial Hypercholesterolemia (FH) management

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Familial hypercholesterolemia (FH) is often underdiagnosed, leading to poor management due to knowledge gaps and misconceptions among both patients and healthcare providers, as identified through a needs assessment involving 22 individuals and 98 survey respondents.

The CARE-FH study implemented evidence-based strategies, such as multidisciplinary care teams and educational programs, to improve the identification and management of FH in primary care settings, highlighting the importance of addressing systemic barriers to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing implementation strategies to improve identification, cascade testing, and management of families with familial hypercholesterolemia: An intervention mapping approach. Jones, LK., Calvo, EM., Campbell-Salome, G., et al.[2023]

Heart and vascular diseases are the leading cause of death globally, highlighting the importance of effective lipid-lowering strategies for high-risk patients.

Nurse-centered case management programs have proven effective in helping high-risk patients adhere to lifestyle changes and medication, leading to better achievement of low-density lipoprotein cholesterol goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipid-lowering therapy today: treating the high-risk cardiovascular patient. Berra, K.[2021]

A three-phase hyperlipidemia outcomes management program is being implemented by 27 US health plans to improve the management of cholesterol levels in patients at risk for coronary heart disease (CHD).

The program aims to enhance patient care and reduce costs by first identifying inefficiencies in cholesterol management, then implementing targeted physician interventions, and finally reassessing patient outcomes after at least 6 months, potentially leading to better health outcomes and increased value for managed care organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A means to an end: an overview of a hyperlipidemia outcomes management program. Patel, B., Perez, HE.[2019]

Statins are effective in lowering low-density lipoprotein cholesterol (LDL-C), which is linked to reduced cardiovascular events, yet many patients do not achieve optimal lipid levels due to poor adherence and lack of follow-up.

Nurse practitioners (NPs) can significantly improve patient outcomes by leading primary care programs, ensuring proper assessment, individualized treatment plans, and consistent follow-up to help patients reach their LDL-C goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nurse practitioner's role in helping patients achieve lipid goals with statin therapy. Mason, CM.[2019]

The multidisciplinary program significantly increased the prescription of lipid-lowering therapy at discharge for patients after acute myocardial infarction (AMI) and percutaneous transluminal coronary angioplasty (PTCA), rising from 40% to between 72-81%.

The program also improved the timely assessment of lipid levels, with the percentage of patients receiving a lipid panel within 24 hours of admission increasing from 13% to between 38-71%, demonstrating enhanced patient care in managing coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for implementing lipid-lowering therapy: pharmacy-based approach. Birtcher, KK., Bowden, C., Ballantyne, CM., et al.[2019]

A systematic review of 86 trials identified 258 different strategies to improve statin use in patients with high cholesterol, showing that multiple strategies can lead to better outcomes in LDL-C reduction, statin prescribing, and adherence.

While the review found that using more implementation strategies generally improved efficacy, no single strategy consistently led to better results, indicating a need for tailored approaches in promoting statin uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation strategies to improve statin utilization in individuals with hypercholesterolemia: a systematic review and meta-analysis. Jones, LK., Tilberry, S., Gregor, C., et al.[2021]

Preventable adverse drug events (pADEs) occur at a median rate of 5.6 per 1000 person-months in ambulatory care, with cardiovascular drugs, analgesics, and hypoglycemic agents accounting for the majority of these events.

Many pADEs lead to hospitalization, highlighting the need for quality improvement programs that focus on reducing prescribing and monitoring errors, particularly for high-risk medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Thomsen, LA., Winterstein, AG., Søndergaard, B., et al.[2022]

The CARE-FH study aims to enhance the diagnosis of Familial Hypercholesterolemia (FH) by integrating its evaluation into primary care, potentially identifying patients before serious cardiovascular issues arise.

The study will implement evidence-based guidelines across various medical specialties and analyze the effectiveness of these strategies in improving diagnostic rates and health outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. Jones, LK., Williams, MS., Ladd, IG., et al.[2023]

The multidisciplinary lipid clinic (MDLC) improved the diagnosis and treatment of lipid conditions, leading to significant reductions in lipid levels among patients, despite only 83 patients being seen in its first year.

The clinic successfully increased the prescribing of evidence-based therapies and achieved high rates of medication prior authorization approvals, indicating its effectiveness in managing complex dyslipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a multidisciplinary lipid clinic to improve the care of individuals with severe lipid conditions: a RE-AIM framework analysis. Jones, LK., McMinn, M., Kann, D., et al.[2022]

A review of 153 articles on improving care for familial hypercholesterolemia (FH) identified 37 studies that mapped to implementation strategies aimed at enhancing clinical care, highlighting the need for better translation of evidence into practice.

Only a small number of studies (8 out of 37) used established implementation science frameworks, indicating a gap in applying systematic approaches to address health disparities and improve FH care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying implementation science to improve care for familial hypercholesterolemia. Jones, LK., Brownson, RC., Williams, MS.[2023]

The use of an ambulatory medication safety dashboard by pharmacists in a 2-year study significantly reduced the risk of emergency department visits by 11.3% and hospitalizations by 12.3% among transplant patients, compared to usual care.

This intervention was particularly effective for patients with lower comorbidity burdens, indicating that targeted medication management can enhance patient safety and reduce healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a multicenter cluster-randomized controlled clinical trial testing the effectiveness of a bioinformatics-enabled pharmacist intervention in transplant recipients. Taber, DJ., Ward, RC., Buchanan, CH., et al.[2023]

The DQIP intervention effectively reduced the prescribing of high-risk NSAIDs and anti-platelets among vulnerable patients, addressing a significant cause of preventable hospital admissions in England.

Participants in the study identified key components of the intervention—financial incentives, education, and informatics tools—as interdependent factors that motivated and sustained changes in prescribing practices, highlighting the importance of a multifaceted approach in quality improvement initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing. Grant, A., Dreischulte, T., Guthrie, B.[2023]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

The study developed a generic process map for integrating High Risk Medicine Care Bundles (CBs) into community pharmacy practice, focusing on warfarin and NSAIDs, based on insights from 27 pharmacies across 4 NHS regions.

Successful delivery of the CBs involves five key steps: patient identification, clinical assessment, pharmacy CB prompt, CB delivery, and documentation, allowing for a whole-team approach with minimal pharmacist involvement required for clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of process mapping to understand integration of high risk medicine care bundles within community pharmacy practice. Weir, NM., Newham, R., Corcoran, ED., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-metabolic-diseases-1-2023-93e8f

Implementation Strategy Bundle for Lipid Disorders The Implementation Strategy Bundle for lipid disorders is unique because it focuses on improving the overall care process through a systematic approach, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11711772/

Learnings from Implementation Strategies to Improve Lipid ... In this review, recent examples of implementation strategies for optimising lipid management are discussed.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666667725000686

Implementation strategies for improving the care of familial ... We describe here the IAS guidance core implementation strategies to assist with the adoption of clinical recommendations into routine practice.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6911646/

Developing implementation strategies to improve uptake ... Findings from this study will help us understand how to improve the adoption of guideline-recommended treatment for individuals with FH.

5. lipidjournal.com lipidjournal.com/article/S1933-2874(24)00002-3/fulltext

Using implementation science to develop a familial ... We designed the Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia (CARE-FH) clinical trial to improve FH screening in primary care.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.011627

An Implementation Initiative to Improve Lipid Management ... The outpatient cholesterol measures of interest for this initiative were Monitoring LDL-C for Patients with ASCVD and LDL-C Control for Patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035916/

Implementation strategies for improving the care of familial ... A total of 80 general and specific implementation recommendations were generated, addressing detection (screening, diagnosis, genetic testing ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S156756882100012X

Implementation of clinical practices and pathways ... In this paper we present eight European initiatives of in- and post-hospital ACS lipid management aimed at overcoming the gaps present in each country.