N/A
Completed N=21,752
Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies
Source: ClinicalTrials.gov NCT01251757 ↗Enrolled (actual)
21,752
Serious AEs
0.3%
Results posted
Feb 2017
Primary outcomePrimary: Adherence to Statins — 0.55; 0.57; 0.58; 0.38 mMPR as a fraction — p=<.001
Summary
The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Statins |
0.55; 0.57; 0.58; 0.38; 0.41; 0.41 | <.001 sig |
| PRIMARY Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) |
0.57; 0.59; 0.61; 0.45; 0.47; 0.50 | 0.022 sig |
| SECONDARY Percentage With Good (>80%) Statin Adherence |
32.9; 35.9; 35.8; 21.5; 22.6; 21.8 | 0.002 sig |
| SECONDARY Percentage With Good (>80%) ACEI/ARB Adherence |
37.4; 40.3; 41.6; 24.5; 27.0; 28.2 | 0.014 sig |
| SECONDARY Systolic Blood Pressure (SBP) |
129.2; 128.6; 129.0; 123.5; 122.8; 123.4 | .041 sig |
| SECONDARY Percentage With Good (<140/90 mmHg) Blood Pressure Control |
81.1; 82.1; 81.3; 93.7; 94.0; 92.9 | .404 |
| SECONDARY Post Intervention Low Density Lipoprotein (LDL) Level |
92.4; 91.8; 91.3; 75.5; 75.5; 75.6 | .38 |
| SECONDARY Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control |
69.1; 69.8; 70.4; 88.4; 88.0; 88.1 | .59 |
Eligibility Criteria
Inclusion Criteria
- Aged 40 years or older as of time of randomization.
- Flagged in KP's databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization
- At least one dispensing of an ACEI, ARB, or statin from a Kaiser Permanente (KP) outpatient pharmacy during the baseline year.
- Suboptimal adherence ((MPR<0.9) to either statins or ACEI/ARBs during the baseline year
- Continuous membership in KP for the 12 months prior to randomization.
- Qualified for an intervention call at the time of randomization.
Exclusion Criteria
- Evidence in the electronic medical record (EMR) of allergy or intolerance to statins or ACE inhibitors/ARBs
- medical conditions that would contraindicate use of statins or ACEI/ARBs
- Absence of either a phone number or mailing address in the EMR
- for Kaiser Permanente Hawaii, clinics whose patients tend to fill prescriptions primarily at non-KP pharmacies
- on Kaiser Permanente's "do not contact" list or in other research studies that could add undue burden
Data sourced from ClinicalTrials.gov (NCT01251757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.