Cardiovascular Disease, Diabetes Mellitus
Conditions
Keywords
diabetes, cardiovascular disease, randomized clinical trial, medication adherence, health information technology, adult, telephone calls, IVR
Brief 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.
Detailed description
The frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.
Interventions
OTHERInteractive Voice Recognition (IVR) phone calls
The IVR intervention consisted of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the electronic medical record (EMR). Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population.
OTHEREducational mailings and follow-up for nonadherence
Participants received bimonthly educational materials by mail. In addition, patients received mailed refill reminder letters and their providers were notified electronically if the patients failed to refill in response to the automated calls. The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as frequently asked questions (FAQs) about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers.
Sponsors
Kaiser Foundation Hospitals, Center for Health Research
Johns Hopkins University
Agency for Healthcare Research and Quality (AHRQ)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Statins | 12 months post randomization | We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications. |
| Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | 12 months post randomization | We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | 12-months post randomization | Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization. |
| Percentage With Good (<140/90 mmHg) Blood Pressure Control | 12 months post randomization | Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP \<140 mmHg and a mean diastolic BP \< 90 mmHg. |
| Percentage With Good (>80%) Statin Adherence | 12 months post randomization | Binary indicator of good statin adherence, defined as an mMPR\>0.80. 1=yes, 0=no. |
| Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | 12 months post randomization | Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level \<= 100 mg/dL. |
| Post Intervention Low Density Lipoprotein (LDL) Level | 12 months post randomization | We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed. |
| Percentage With Good (>80%) ACEI/ARB Adherence | 12 months post randomization | Binary indicator of good ACEI/ARB adherence, defined as an mMPR\>0.80. 1=yes, 0=no. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (UC) Participants in this arm had full access to all care they were normally entitled to as part of usual care | 7,255 |
| Interactive Voice Recognition (IVR) In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.
The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population. | 7,247 |
| Enhanced IVR (IVR+) Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.
The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers. | 7,250 |
| Total | 21,752 |
Baseline characteristics
| Characteristic | Enhanced IVR (IVR+) | Total | Usual Care (UC) | Interactive Voice Recognition (IVR) |
|---|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 12.2 | 63.6 years STANDARD_DEVIATION 12.2 | 63.6 years STANDARD_DEVIATION 12.2 | 63.6 years STANDARD_DEVIATION 12.1 |
| co-morbid cardiovascular disease no | 4589 participants | 13849 participants | 4629 participants | 4631 participants |
| co-morbid cardiovascular disease yes | 2661 participants | 7903 participants | 2626 participants | 2616 participants |
| co-morbid diabetes mellitus no | 1624 participants | 4757 participants | 1589 participants | 1544 participants |
| co-morbid diabetes mellitus yes | 5626 participants | 16995 participants | 5666 participants | 5703 participants |
| ever smokers no | 3690 participants | 11173 participants | 3773 participants | 3710 participants |
| ever smokers yes | 3560 participants | 10579 participants | 3482 participants | 3537 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 44 Participants | 138 Participants | 51 Participants | 43 Participants |
| Race (NIH/OMB) Asian | 1254 Participants | 3814 Participants | 1270 Participants | 1290 Participants |
| Race (NIH/OMB) Black or African American | 1109 Participants | 3371 Participants | 1168 Participants | 1094 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 783 Participants | 2400 Participants | 798 Participants | 819 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 652 Participants | 1819 Participants | 565 Participants | 602 Participants |
| Race (NIH/OMB) White | 3408 Participants | 10210 Participants | 3403 Participants | 3399 Participants |
| Region of Enrollment United States | 7250 participants | 21752 participants | 7255 participants | 7247 participants |
| Sex: Female, Male Female | 3415 Participants | 10217 Participants | 3432 Participants | 3370 Participants |
| Sex: Female, Male Male | 3835 Participants | 11535 Participants | 3823 Participants | 3877 Participants |
| target medication use ACEI/ARB only | 1820 participants | 5380 participants | 1770 participants | 1790 participants |
| target medication use statin and ACEI/ARB | 2508 participants | 7656 participants | 2561 participants | 2587 participants |
| target medication use statin only | 2922 participants | 8716 participants | 2924 participants | 2870 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 141 / 7,255 | 146 / 7,247 | 140 / 7,250 |
| other Total, other adverse events | 0 / 7,255 | 0 / 7,247 | 0 / 7,250 |
| serious Total, serious adverse events | 25 / 7,255 | 21 / 7,247 | 22 / 7,250 |
Outcome results
Primary
Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)
We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.
Time frame: 12 months post randomization
Population: All randomized participants who were taking an ACEI or an ARB at the time of randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UC) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence 0.75-0.90 | 0.76 mMPR expressed as a fraction | Standard Deviation 0.26 |
| Usual Care (UC) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence 0.50-0.75 | 0.69 mMPR expressed as a fraction | Standard Deviation 0.3 |
| Usual Care (UC) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence <=0.50 | 0.45 mMPR expressed as a fraction | Standard Deviation 0.37 |
| Usual Care (UC) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | overall | 0.57 mMPR expressed as a fraction | Standard Deviation 0.36 |
| Interactive Voice Recognition (IVR) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence <=0.50 | 0.47 mMPR expressed as a fraction | Standard Deviation 0.37 |
| Interactive Voice Recognition (IVR) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence 0.75-0.90 | 0.76 mMPR expressed as a fraction | Standard Deviation 0.28 |
| Interactive Voice Recognition (IVR) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | overall | 0.59 mMPR expressed as a fraction | Standard Deviation 0.35 |
| Interactive Voice Recognition (IVR) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence 0.50-0.75 | 0.70 mMPR expressed as a fraction | Standard Deviation 0.29 |
| Enhanced IVR (IVR+) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence 0.75-0.90 | 0.77 mMPR expressed as a fraction | Standard Deviation 0.29 |
| Enhanced IVR (IVR+) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | overall | 0.61 mMPR expressed as a fraction | Standard Deviation 0.34 |
| Enhanced IVR (IVR+) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence 0.50-0.75 | 0.71 mMPR expressed as a fraction | Standard Deviation 0.29 |
| Enhanced IVR (IVR+) | Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | baseline adherence <=0.50 | 0.50 mMPR expressed as a fraction | Standard Deviation 0.36 |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: 0.02295% CI: [0.002, 0.029]Regression, Linear
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: <0.00195% CI: [0.023, 0.05]Regression, Linear
Primary
Adherence to Statins
We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.
Time frame: 12 months post randomization
Population: All randomized participants who were taking statins at the time of randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UC) | Adherence to Statins | baseline adherence <= 0.40 | 0.38 mMPR as a fraction | Standard Deviation 0.37 |
| Usual Care (UC) | Adherence to Statins | baseline adherence 0.4-0.75 | 0.61 mMPR as a fraction | Standard Deviation 0.31 |
| Usual Care (UC) | Adherence to Statins | baseline adherence 0.75-0.90 | 0.75 mMPR as a fraction | Standard Deviation 0.27 |
| Usual Care (UC) | Adherence to Statins | overall | 0.55 mMPR as a fraction | Standard Deviation 0.35 |
| Interactive Voice Recognition (IVR) | Adherence to Statins | baseline adherence 0.4-0.75 | 0.63 mMPR as a fraction | Standard Deviation 0.31 |
| Interactive Voice Recognition (IVR) | Adherence to Statins | baseline adherence 0.75-0.90 | 0.77 mMPR as a fraction | Standard Deviation 0.27 |
| Interactive Voice Recognition (IVR) | Adherence to Statins | baseline adherence <= 0.40 | 0.41 mMPR as a fraction | Standard Deviation 0.36 |
| Interactive Voice Recognition (IVR) | Adherence to Statins | overall | 0.57 mMPR as a fraction | Standard Deviation 0.34 |
| Enhanced IVR (IVR+) | Adherence to Statins | baseline adherence 0.75-0.90 | 0.75 mMPR as a fraction | Standard Deviation 0.29 |
| Enhanced IVR (IVR+) | Adherence to Statins | baseline adherence 0.4-0.75 | 0.65 mMPR as a fraction | Standard Deviation 0.3 |
| Enhanced IVR (IVR+) | Adherence to Statins | overall | 0.58 mMPR as a fraction | Standard Deviation 0.34 |
| Enhanced IVR (IVR+) | Adherence to Statins | baseline adherence <= 0.40 | 0.41 mMPR as a fraction | Standard Deviation 0.36 |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: <0.00195% CI: [0.011, 0.034]Regression, Linear
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: <0.00195% CI: [0.019, 0.042]Regression, Linear
Secondary
Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control
Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level \<= 100 mg/dL.
Time frame: 12 months post randomization
Population: All randomized participants who were taking a statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care (UC) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL > 100 mg/dL | 39.9 percentage with controlled LDL |
| Usual Care (UC) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL 80-100 mg/dL | 73.7 percentage with controlled LDL |
| Usual Care (UC) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Overall | 69.1 percentage with controlled LDL |
| Usual Care (UC) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL <=80 mg/dL | 88.4 percentage with controlled LDL |
| Interactive Voice Recognition (IVR) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL > 100 mg/dL | 43.5 percentage with controlled LDL |
| Interactive Voice Recognition (IVR) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Overall | 69.8 percentage with controlled LDL |
| Interactive Voice Recognition (IVR) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL <=80 mg/dL | 88.0 percentage with controlled LDL |
| Interactive Voice Recognition (IVR) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL 80-100 mg/dL | 74.0 percentage with controlled LDL |
| Enhanced IVR (IVR+) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Overall | 70.4 percentage with controlled LDL |
| Enhanced IVR (IVR+) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL > 100 mg/dL | 44.1 percentage with controlled LDL |
| Enhanced IVR (IVR+) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL 80-100 mg/dL | 74.9 percentage with controlled LDL |
| Enhanced IVR (IVR+) | Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Baseline LDL <=80 mg/dL | 88.1 percentage with controlled LDL |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.p-value: 0.5995% CI: [0.93, 1.13]Regression, Logistic
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.p-value: 0.05895% CI: [1, 1.22]Regression, Logistic
Secondary
Percentage With Good (<140/90 mmHg) Blood Pressure Control
Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP \<140 mmHg and a mean diastolic BP \< 90 mmHg.
Time frame: 12 months post randomization
Population: All randomized participants who were taking an ACEI or an ARB at the time of randomization and who had at least one post randomization BP recorded in the EMR. Missing data were not imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care (UC) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Overall | 81.1 percentage of subjects with good control |
| Usual Care (UC) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP<=130 mmHg | 93.7 percentage of subjects with good control |
| Usual Care (UC) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP 130-140 mmHg | 78.4 percentage of subjects with good control |
| Usual Care (UC) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP>140 mmHg | 49.2 percentage of subjects with good control |
| Interactive Voice Recognition (IVR) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP>140 mmHg | 52.4 percentage of subjects with good control |
| Interactive Voice Recognition (IVR) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Overall | 82.1 percentage of subjects with good control |
| Interactive Voice Recognition (IVR) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP 130-140 mmHg | 78.4 percentage of subjects with good control |
| Interactive Voice Recognition (IVR) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP<=130 mmHg | 94.0 percentage of subjects with good control |
| Enhanced IVR (IVR+) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP>140 mmHg | 50.2 percentage of subjects with good control |
| Enhanced IVR (IVR+) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP<=130 mmHg | 92.9 percentage of subjects with good control |
| Enhanced IVR (IVR+) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Baseline SBP 130-140 mmHg | 78.3 percentage of subjects with good control |
| Enhanced IVR (IVR+) | Percentage With Good (<140/90 mmHg) Blood Pressure Control | Overall | 81.3 percentage of subjects with good control |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.p-value: 0.40495% CI: [0.93, 1.19]Regression, Logistic
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.p-value: 0.5495% CI: [0.85, 1.09]Regression, Logistic
Secondary
Percentage With Good (>80%) ACEI/ARB Adherence
Binary indicator of good ACEI/ARB adherence, defined as an mMPR\>0.80. 1=yes, 0=no.
Time frame: 12 months post randomization
Population: All randomized participants who were taking an ACEI or an ARB at the time of randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care (UC) | Percentage With Good (>80%) ACEI/ARB Adherence | Overall | 37.4 Percent with good adherence |
| Usual Care (UC) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence <=0.50 | 24.5 Percent with good adherence |
| Usual Care (UC) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence 0.50-0.75 | 48.4 Percent with good adherence |
| Usual Care (UC) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence 0.75-0-.90 | 59.7 Percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence 0.75-0-.90 | 62.0 Percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) ACEI/ARB Adherence | Overall | 40.3 Percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence 0.50-0.75 | 51.1 Percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence <=0.50 | 27.0 Percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence 0.75-0-.90 | 66.8 Percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence <=0.50 | 28.2 Percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) ACEI/ARB Adherence | Baseline adherence 0.50-0.75 | 52.0 Percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) ACEI/ARB Adherence | Overall | 41.6 Percent with good adherence |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: 0.01495% CI: [1.02, 1.23]Regression, Logistic
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: <0.00195% CI: [1.1, 1.32]Regression, Logistic
Secondary
Percentage With Good (>80%) Statin Adherence
Binary indicator of good statin adherence, defined as an mMPR\>0.80. 1=yes, 0=no.
Time frame: 12 months post randomization
Population: All randomized participants who were taking statins at the time of randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care (UC) | Percentage With Good (>80%) Statin Adherence | Overall | 32.9 percent with good adherence |
| Usual Care (UC) | Percentage With Good (>80%) Statin Adherence | baseline adherence <=0.40 | 21.5 percent with good adherence |
| Usual Care (UC) | Percentage With Good (>80%) Statin Adherence | baseline adherence 0.4-0.75 | 36.2 percent with good adherence |
| Usual Care (UC) | Percentage With Good (>80%) Statin Adherence | baseline adherence 0.75-0.90 | 58.1 percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) Statin Adherence | baseline adherence 0.75-0.90 | 63.5 percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) Statin Adherence | Overall | 35.9 percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) Statin Adherence | baseline adherence 0.4-0.75 | 39.4 percent with good adherence |
| Interactive Voice Recognition (IVR) | Percentage With Good (>80%) Statin Adherence | baseline adherence <=0.40 | 22.6 percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) Statin Adherence | baseline adherence 0.75-0.90 | 62.6 percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) Statin Adherence | baseline adherence <=0.40 | 21.8 percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) Statin Adherence | baseline adherence 0.4-0.75 | 40.1 percent with good adherence |
| Enhanced IVR (IVR+) | Percentage With Good (>80%) Statin Adherence | Overall | 35.8 percent with good adherence |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: 0.00295% CI: [1.05, 1.24]Regression, Logistic
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.p-value: <0.00195% CI: [1.06, 1.26]Regression, Logistic
Secondary
Post Intervention Low Density Lipoprotein (LDL) Level
We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.
Time frame: 12 months post randomization
Population: All randomized participants who were taking statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UC) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL 80-100 mg/dL | 92.0 mg/dL | Standard Deviation 27.8 |
| Usual Care (UC) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL>100 mg/dL | 114.9 mg/dL | Standard Deviation 37.9 |
| Usual Care (UC) | Post Intervention Low Density Lipoprotein (LDL) Level | Overall | 92.4 mg/dL | Standard Deviation 35.3 |
| Usual Care (UC) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL <=80 mg/dL | 75.5 mg/dL | Standard Deviation 26.1 |
| Interactive Voice Recognition (IVR) | Post Intervention Low Density Lipoprotein (LDL) Level | Overall | 91.8 mg/dL | Standard Deviation 34 |
| Interactive Voice Recognition (IVR) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL>100 mg/dL | 113.0 mg/dL | Standard Deviation 37.9 |
| Interactive Voice Recognition (IVR) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL 80-100 mg/dL | 91.5 mg/dL | Standard Deviation 25.9 |
| Interactive Voice Recognition (IVR) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL <=80 mg/dL | 75.5 mg/dL | Standard Deviation 25.7 |
| Enhanced IVR (IVR+) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL>100 mg/dL | 111.4 mg/dL | Standard Deviation 36.6 |
| Enhanced IVR (IVR+) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL <=80 mg/dL | 75.6 mg/dL | Standard Deviation 26.1 |
| Enhanced IVR (IVR+) | Post Intervention Low Density Lipoprotein (LDL) Level | Baseline LDL 80-100 mg/dL | 90.7 mg/dL | Standard Deviation 24.9 |
| Enhanced IVR (IVR+) | Post Intervention Low Density Lipoprotein (LDL) Level | Overall | 91.3 mg/dL | Standard Deviation 33.3 |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.p-value: 0.3895% CI: [-1.8, 0.7]Regression, Linear
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.p-value: 0.01995% CI: [-2.7, -0.2]Regression, Linear
Secondary
Systolic Blood Pressure (SBP)
Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.
Time frame: 12-months post randomization
Population: The analysis sample was restricted to ACEI/ARB users with at least one post intervention SBP measurement recorded in the EMR. We did not impute any missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UC) | Systolic Blood Pressure (SBP) | Baseline SBP>140mmHg | 140.6 mm Hg | Standard Deviation 13.3 |
| Usual Care (UC) | Systolic Blood Pressure (SBP) | Overall | 129.2 mm Hg | Standard Deviation 13.1 |
| Usual Care (UC) | Systolic Blood Pressure (SBP) | Baseline SBP<=130mmHg | 123.5 mm Hg | Standard Deviation 10.7 |
| Usual Care (UC) | Systolic Blood Pressure (SBP) | Baseline SBP 130-140mmHg | 132.8 mm Hg | Standard Deviation 10.7 |
| Interactive Voice Recognition (IVR) | Systolic Blood Pressure (SBP) | Baseline SBP 130-140mmHg | 132.2 mm Hg | Standard Deviation 10.1 |
| Interactive Voice Recognition (IVR) | Systolic Blood Pressure (SBP) | Baseline SBP>140mmHg | 140.4 mm Hg | Standard Deviation 13.2 |
| Interactive Voice Recognition (IVR) | Systolic Blood Pressure (SBP) | Baseline SBP<=130mmHg | 122.8 mm Hg | Standard Deviation 11.1 |
| Interactive Voice Recognition (IVR) | Systolic Blood Pressure (SBP) | Overall | 128.6 mm Hg | Standard Deviation 13.2 |
| Enhanced IVR (IVR+) | Systolic Blood Pressure (SBP) | Baseline SBP 130-140mmHg | 132.7 mm Hg | Standard Deviation 10.1 |
| Enhanced IVR (IVR+) | Systolic Blood Pressure (SBP) | Overall | 129.0 mm Hg | Standard Deviation 13.2 |
| Enhanced IVR (IVR+) | Systolic Blood Pressure (SBP) | Baseline SBP<=130mmHg | 123.4 mm Hg | Standard Deviation 11.1 |
| Enhanced IVR (IVR+) | Systolic Blood Pressure (SBP) | Baseline SBP>140mmHg | 140.9 mm Hg | Standard Deviation 13.2 |
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.p-value: 0.04195% CI: [-1, 0]Regression, Linear
Comparison: We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.p-value: 0.9395% CI: [-0.5, 0.5]Regression, Linear