Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

About this trial

The purpose of this study is to determine whether a proactive, EHR-guided approach helps more individuals reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care.

The main question it aims to answer is:

• Does the EHR-LOCALE pathway increases the proportion of patients who reach the LDL-cholesterol target of \<1.8 mmol/L at 6 months?

Participants in the interventional group receive:

* Pharmacist contact * Repeat lipid requisitions * Review of medications, adherence, and side effects * Treatment escalation according to national dyslipidemia guidelines

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults over the age of 18

Resident of Alberta

Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.

Able to participate in follow-up contact if randomized to the intervention arm

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pharmacist-led lipid optimization pathway

    Other intervention

    Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: Quality-improvement interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months

Time frame
From enrollment to the end of intervention at 6 months

Secondary outcomes

1

Proportion of individuals with repeat lipid panel testing at 3-months and 6-months

Time frame
From enrollment to the end of intervention at 6 months
2

Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies

Time frame
From enrollment to the end of intervention at 6 months
3

Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months

Time frame
From enrollment to the end of intervention at 6 months
4

Composite of all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke and unplanned coronary revascularization at one-year and five-years

Time frame
From enrollment to 1 year and 5 years

Other outcomes

1

Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS

Time frame
From enrollment to the end of intervention at 6 months

Sponsors and contacts

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