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| Name | Class |
|---|---|
| Kaiser Foundation Hospitals, Center for Health Research | OTHER |
| Johns Hopkins University | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (UC) | No Intervention | Participants in this arm received their usual care with no restrictions. | |
| Interactive Voice Recognition (IVR) | Active Comparator | automated phone calls |
|
| Enhanced IVR (IVR+) | Active Comparator | automated phone calls & Educational mailings and follow-up for nonadherence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Voice Recognition (IVR) phone calls | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post randomization |
| 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. | 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage With Good (>80%) Statin Adherence | Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no. | 12 months post randomization |
| Percentage With Good (>80%) ACEI/ARB Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William M Vollmer, PhD | Center for Health Research, Kaiser Permanente Northwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Health Research, Kaiser Permanente Southeast | Atlanta | Georgia | 30305 | United States | ||
| Center for Health Research, Kaiser Permanente Hawaii |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25811824 | Result | Vollmer WM, Owen-Smith AA, Tom JO, Laws R, Ditmer DG, Smith DH, Waterbury AC, Schneider JL, Yonehara CH, Williams A, Vupputuri S, Rand CS. Improving adherence to cardiovascular disease medications with information technology. Am J Manag Care. 2014 Nov;20(11 Spec No. 17):SP502-10. | |
| 27021751 | Result | Smith DH, O'Keeffe-Rosetti M, Owen-Smith AA, Rand C, Tom J, Vupputuri S, Laws R, Waterbury A, Hankerson-Dyson DD, Yonehara C, Williams A, Schneider J, Dickerson JF, Vollmer WM. Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial. Value Health. 2016 Mar-Apr;19(2):176-84. doi: 10.1016/j.jval.2015.11.013. Epub 2016 Feb 12. |
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At the request of AHRQ we did not create a formal public data release.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care (UC) | Participants in this arm had full access to all care they were normally entitled to as part of usual care |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care (UC) | Participants in this arm had full access to all care they were normally entitled to as part of usual care |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants who were taking statins at the time of randomization | Posted | Mean | Standard Deviation | mMPR as a fraction | 12 months post randomization |
|
12 months post randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care (UC) | usual medical care | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| potential ACEI/ARB related hospitalization | Vascular disorders | Systematic Assessment | organ system categorization is incomplete. this includes hospitalization for acute renal failure, angioedema, anaphylactic shock, and anaphylactic hypotension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William M Vollmer, PhD | Kaiser Permanente Center for Health Research | 503-335-2400 | william.vollmer@kpchr.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
|
| Educational mailings and follow-up for nonadherence | Other | 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. |
|
|
Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.
| 12 months post randomization |
| Systolic Blood Pressure (SBP) | Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization. | 12-months post randomization |
| 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. | 12 months post randomization |
| 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. | 12 months post randomization |
| 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. | 12 months post randomization |
| Honolulu |
| Hawaii |
| 96817 |
| United States |
| Center for Health Research, Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| 27352409 | Result | Owen-Smith AA, Smith DH, Rand CS, Tom JO, Laws R, Waterbury A, Williams A, Vollmer WM. Difference in Effectiveness of Medication Adherence Intervention by Health Literacy Level. Perm J. 2016 Summer;20(3):15-200. doi: 10.7812/TPP/15-200. Epub 2016 Jun 29. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ever smokers | Number | participants |
|
| co-morbid diabetes mellitus | Number | participants |
|
| co-morbid cardiovascular disease | Number | participants |
|
| target medication use | Number | participants |
|
| Usual Care (UC) |
statin users in UC arm |
| OG001 | Interactive Voice Recognition (IVR) | statin users in IVR arm |
| OG002 | Enhanced IVR (IVR+) | statin users in IVR+ arm |
|
|
|
| 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. | All randomized participants who were taking an ACEI or an ARB at the time of randomization | Posted | Mean | Standard Deviation | mMPR expressed as a fraction | 12 months post randomization |
|
|
|
|
| Secondary | Percentage With Good (>80%) Statin Adherence | Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no. | All randomized participants who were taking statins at the time of randomization. | Posted | Number | percent with good adherence | 12 months post randomization |
|
|
|
|
| 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. | All randomized participants who were taking an ACEI or an ARB at the time of randomization | Posted | Number | Percent with good adherence | 12 months post randomization |
|
|
|
|
| Secondary | Systolic Blood Pressure (SBP) | Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization. | 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. | Posted | Mean | Standard Deviation | mm Hg | 12-months post randomization |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects with good control | 12 months post randomization |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | 12 months post randomization |
|
|
|
|
| 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. | 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. | Posted | Number | percentage with controlled LDL | 12 months post randomization |
|
|
|
|
| 7,255 |
| 25 |
| 7,255 |
| 0 |
| 7,255 |
| EG001 | Interactive Voice Recognition (IVR) | usual care plus automated phone calls | 146 | 7,247 | 21 | 7,247 | 0 | 7,247 |
| EG002 | Enhanced IVR (IVR+) | usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence | 140 | 7,250 | 22 | 7,250 | 0 | 7,250 |
|
| potential statin related hospitalization | Hepatobiliary disorders | Systematic Assessment | specifically includes hospitalizations for liver failure or cirrhosis rhabdomyolysis as a primary discharge diagnosis |
|
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| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
|
| baseline adherence 0.50-0.75 |
|
| baseline adherence 0.75-0.90 |
|
| Superiority or Other |
| 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. | Regression, Linear | Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence. | <.001 | Mean Difference (Final Values) | 0.037 | 2-Sided | 95 | 0.023 | 0.050 | Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC. | Superiority or Other |
|
| baseline adherence 0.4-0.75 |
|
| baseline adherence 0.75-0.90 |
|
| Superiority or Other |
| 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. | Regression, Logistic | <0.001 | Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence. | Odds Ratio (OR) | 1.16 | 2-Sided | 95 | 1.06 | 1.26 | Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC. | Superiority or Other |
| Baseline adherence <=0.50 |
|
|
| Baseline adherence 0.50-0.75 |
|
|
| Baseline adherence 0.75-0-.90 |
|
|
| Superiority or Other |
| 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. | Regression, Logistic | <0.001 | Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence. | Odds Ratio (OR) | 1.21 | 2-Sided | 95 | 1.10 | 1.32 | Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC. | Superiority or Other |
| Baseline SBP<=130mmHg |
|
|
| Baseline SBP 130-140mmHg |
|
|
| Baseline SBP>140mmHg |
|
|
| Superiority or Other |
| 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. | Regression, Linear | Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group. | .93 | As noted above, the a priori threshold for statistical significance for this test was .025. | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -.5 | .5 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Baseline SBP 130-140 mmHg |
|
| Baseline SBP>140 mmHg |
|
| Superiority or Other |
| 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. | Regression, Logistic | Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group | .54 | As noted above, the a priori threshold for statistical significance for this test was .025. | Odds Ratio (OR) | .96 | 2-Sided | 95 | .85 | 1.09 | Superiority or Other |
| Baseline LDL <=80 mg/dL |
|
|
| Baseline LDL 80-100 mg/dL |
|
|
| Baseline LDL>100 mg/dL |
|
|
| Superiority or Other |
| 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. | Regression, Linear | adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group. | .019 | As noted above, the a priori threshold for statistical significance for this test was .025. | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -2.7 | -0.2 | MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002). | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Baseline LDL 80-100 mg/dL |
|
| Baseline LDL > 100 mg/dL |
|
| Superiority or Other |
| 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. | Regression, Logistic | Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group. | .058 | As noted above, the a priori threshold for statistical significance for this test was .025. | Odds Ratio (OR) | 1.10 | 2-Sided | 95 | 1.00 | 1.22 | Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015). | Superiority or Other |