Implementation Strategy Bundle for Lipid Disorders

(DONATE-FH Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Amit Khera, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Cholesterol medications, Statin interactors

Disqualifiers: Pregnancy, Chronic liver disease, others

No Placebo Group

Approved in 2 Jurisdictions

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

Research Team

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.

Trial 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 (Behavioral Intervention)
• Usual care notification (Other)

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').

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UT Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1102

Patients Recruited

1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A means to an end: an overview of a hyperlipidemia outcomes management program. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Strategies for implementing lipid-lowering therapy: pharmacy-based approach. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Application of process mapping to understand integration of high risk medicine care bundles within community pharmacy practice. [2018]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. [2022]

10. England 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. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Designing implementation strategies to improve identification, cascade testing, and management of families with familial hypercholesterolemia: An intervention mapping approach. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Implementation strategies to improve statin utilization in individuals with hypercholesterolemia: a systematic review and meta-analysis. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Applying implementation science to improve care for familial hypercholesterolemia. [2023]