A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. (1821534-10)

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Pharmacists; Hypercholesterolemia; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Cardiovascular Diseases; Placebo Effect

Treatments: Other: Virtual Statin Management (VSM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06423365

1821534-10

R01HL157439

Details and patient eligibility

About

The goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are:

1. Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy?
2. Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy?

Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change.

All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed.

Enrollment: 816 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• KPCO member
• Sold a statin from KPCO pharmacy in the previous six months
• Have a gap of >1.0x the days' supply in refilling their statin
• Patient who stopped therapy (or delayed filling prescription) due to some perceived side effect
• Has email address available in kp.org (and therefore has access to a computer with internet)

Exclusion criteria

• Unable to verbalize comprehension of study or impaired decision-making
• Non-English speaking
• Limited life expectancy (e.g. hospice or palliative care)
• Pregnant or planning to become pregnant
• Patients on Kaiser Permanente's "do not call" list for research will also be excluded.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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816 participants in 2 patient groups

Usual care

No Intervention group

Description:

Participants randomized to usual care will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions.

Usual Care + Virtual Statin Management (VSM)

Experimental group

Description:

Participants randomized to usual care + virtual statin management (VSM) will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions, and they will also be given a link to engage with the VSM website. The VSM website is an educational tool which has four principal components: 1) learning how to distinguish if and when muscle symptoms are caused by the statin; 2) learning the essentials about heart disease, focusing on causes, risk factors, and the crucial role of cholesterol management in prevention; exploring various cholesterol lowering options, including when it makes sense to retry a statin and what options exist beyond statins; and 4) learning to engage in productive discussions with healthcare providers and set effective treatment goals together.

Treatment:

Other: Virtual Statin Management (VSM)