Cardiovascular Diseases, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Pharmacists, Placebo Effect
Conditions
Brief summary
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.
Interventions
OTHERVirtual Statin Management (VSM)
VSM is a web-based decision aid to help manage statin therapy after experiencing muscle pain perceived to be caused or worsened by their statin therapy. The introduction will feature a brief explanation of the tool and what they can expect. The modules are: 1. General education (lipids, heart disease, medications) 2. Side effects (causes, diagnosis). 3. Statin modifications. VSM will guide patients to understand their lipid-lowering options, particularly their statin options that may best match patients' stated preferences. 4. ASCVD risk \& statin benefit. Finally, the VSM experience will end by providing the patient with a summary of the results of their use of the tool, which can be used during discussions with their healthcare provider. The information gathered from the VSM will remain confidential and will not be disclosed to anyone other than the patient.
Sponsors
University of Utah
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who retry statin therapy | 30 days post-enrollment | Measured using pharmacy dispensing records |
| Number of participants who continue to take statin therapy | 6 months post-enrollment | Measured using pharmacy dispensing records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| How adherent participants are to prescribed statin therapy | 6 months post-enrollment | Measured using pharmacy dispensing records, using the proportion of days' covered calculation metric (range: 0-100%, where 100% means perfectly adherent) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJordan B King, PharmD, MS
University of Utah
Outcome results
None listed