100 Participants Needed

Implementation Strategy Bundle for Lipid Disorders

(DONATE-FH Trial)

AK
SD
LC
Overseen ByLakeisha Cade
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).

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 data supports the effectiveness of the Implementation Strategy Bundle for Lipid Disorders treatment?

Research shows that programs focusing on quality improvement and multidisciplinary approaches, like the Implementation Strategy Bundle, can improve patient care and help achieve cholesterol goals. For example, nurse-centered case management and multidisciplinary clinics have been successful in helping patients reach their lipid targets, which can reduce the risk of heart disease.12345

Is the Implementation Strategy Bundle generally safe for humans?

The research articles do not provide specific safety data for the Implementation Strategy Bundle or similar interventions for lipid disorders, but they discuss general safety concerns and strategies to prevent adverse events in healthcare settings.678910

How is the Implementation Strategy Bundle treatment for lipid disorders different from other treatments?

The Implementation Strategy Bundle for lipid disorders is unique because it focuses on improving the overall care process through a systematic approach, targeting identification, testing, and management of lipid disorders, rather than just prescribing medication. This approach uses implementation science to address barriers in care and improve the use of evidence-based guidelines, making it different from traditional treatments that primarily focus on medication alone.211121314

Research Team

AK

Amit Khera, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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
I am between 18 and 75 years old.

Exclusion Criteria

Pregnancy
Identified secondary cause of elevated lipids
I am currently on medication to lower my cholesterol.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Implementation Strategy Bundle
  • Usual care notification
Trial OverviewThe 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').
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Intervention Group (Implementation strategy bundle)Experimental Treatment2 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 Treatment1 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

Find a Clinic Near You

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+

Findings from Research

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.
Lipid-lowering therapy today: treating the high-risk cardiovascular patient.Berra, K.[2021]
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.
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 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.
A means to an end: an overview of a hyperlipidemia outcomes management program.Patel, B., Perez, HE.[2019]

References

Lipid-lowering therapy today: treating the high-risk cardiovascular patient. [2021]
Evaluation of a multidisciplinary lipid clinic to improve the care of individuals with severe lipid conditions: a RE-AIM framework analysis. [2022]
A means to an end: an overview of a hyperlipidemia outcomes management program. [2019]
The nurse practitioner's role in helping patients achieve lipid goals with statin therapy. [2019]
Strategies for implementing lipid-lowering therapy: pharmacy-based approach. [2019]
Adverse events in community care: implications for practice, policy and research. [2019]
Application of process mapping to understand integration of high risk medicine care bundles within community pharmacy practice. [2018]
Results of a multicenter cluster-randomized controlled clinical trial testing the effectiveness of a bioinformatics-enabled pharmacist intervention in transplant recipients. [2023]
Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. [2022]
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. [2023]
Designing implementation strategies to improve identification, cascade testing, and management of families with familial hypercholesterolemia: An intervention mapping approach. [2023]
Implementation strategies to improve statin utilization in individuals with hypercholesterolemia: a systematic review and meta-analysis. [2021]
Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. [2023]
Applying implementation science to improve care for familial hypercholesterolemia. [2023]