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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL157439 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Statin Management (VSM) | Other | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who retry statin therapy | Measured using pharmacy dispensing records | 30 days post-enrollment |
| Number of participants who continue to take statin therapy | Measured using pharmacy dispensing records | 6 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| How adherent participants are to prescribed statin therapy | Measured using pharmacy dispensing records, using the proportion of days' covered calculation metric (range: 0-100%, where 100% means perfectly adherent) | 6 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants satisfied with their treatment | Assessed using two questions inspired by the Treatment Satisfaction with Medication Questionnaire. Participants the degree to which they agree or disagree (5-point Likert) regarding their satisfaction with cholesterol-lowering medication. | 6 months post-enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan B King, PharmD, MS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Colorado | Aurora | Colorado | 80011 | United States |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Participant-reported decisional conflict |
Assessed using the Decisional Conflict Scale, 10-item, 3-response (https://decisionaid.ohri.ca/docs/develop/Tools/DCS\_LowLiteracy\_English.pdf). Participants indicate "yes", "unsure", or "no" to 10 questions assessing their decisional conflict regarding their decision to use cholesterol-lowering medication. |
| 1 month post-enrollment |
| Participant-reported decision self-efficacy | Measured using the Decision Self-Efficacy Scale, 11-item, 3-response (https://decisionaid.ohri.ca/docs/develop/User\_Manuals/UM\_Decision\_SelfEfficacy.pdf). Participants indicate their level of confidence from 0 (not at all confident) to 4 (very confident) regarding their decision to use cholesterol-lowering medication. | 6 months post-enrollment |
| Participant-reported perception of cardiovascular disease risk | Adapted from 3 questions used in the Prospective Assessment of Lipid Management (PALM) registry (https://classic.clinicaltrials.gov/ct2/show/NCT02341664). Participants indicate their perceived risk for having a heart disease event. | 6 months post-enrollment |
| Participant-reported degree of trust in healthcare | Measured using the Trust in Physician Scale, 11-item (https://pubmed.ncbi.nlm.nih.gov/2084735/). Participants indicate the degree to which they agree or disagree (5-point Likert scale) with statements regarding their trust in healthcare personnel. | 6 months post-enrollment |
| Participant-reported statin conspiracy beliefs | Participants indicate the degree to which they agree or disagree with 18 statements regarding potential statin-related harms or conspiracies. Answer options of strongly disagree, disagree, neither agree nor disagree, agree, strongly agree, or Not sure. Agreement with the statement indicates a negative belief about statins. | 6 months post-enrollment |
| Participant-reported decision regret | Measured using the Decision Regret Scale, 5-item, 5-response (https://decisionaid.ohri.ca/docs/develop/User\_Manuals/UM\_Regret\_Scale.pdf). Participant indicate the degree to which they agree or disagree (5-point Likert Scale) with 5 statements regarding their choice to use cholesterol-lowering medication. | 6 months post-enrollment |
| D009750 |
| Nutritional and Metabolic Diseases |