Diabetes MellitusPATIENTNCT01251757
Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies
A study testing Interactive Voice Recognition (IVR) phone calls and Educational mailings and follow-up for nonadherence in people with Diabetes Mellitus and Cardiovascular Disease, run by Kaiser Permanente at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Disease
- What is being tested?
- Interactive Voice Recognition (IVR) phone calls and Educational mailings and follow-up for nonadherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,752 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Health Research, Kaiser Permanente Southeast
Atlanta, Georgia, 30305
Center for Health Research, Kaiser Permanente Hawaii
Honolulu, Hawaii, 96817
Center for Health Research, Kaiser Permanente Northwest
Portland, Oregon, 97227
About this study
Official title: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Cardiovascular Disease
- Being tested
- Interactive Voice Recognition (IVR) phone calls, Educational mailings and follow-up for nonadherence
- Keywords
- diabetes, cardiovascular disease, randomized clinical trial, medication adherence, health information technology, adult, telephone calls, IVR
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice Recognition (IVR) phone callsOther
Also called automated 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.
Educational mailings and follow-up for nonadherenceOther
Also called mail follow-up for nonadherence, educational mailings
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Interactive Voice Recognition (IVR) phone calls |
| Enhanced IVR (IVR+) | Active comparator | automated phone calls \& Educational mailings and follow-up for nonadherence Receives: Other: Interactive Voice Recognition (IVR) phone calls; Other: Educational mailings and follow-up for nonadherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months post randomization
Secondary outcomes (6)
Percentage With Good (>80%) Statin Adherence
Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.
Measured: 12 months post randomization
Percentage With Good (>80%) ACEI/ARB Adherence
Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Hospitals, Center for Health Research, Johns Hopkins University, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- William M Vollmer, PhD, Principal investigator, Center for Health Research, Kaiser Permanente Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251757
- Sponsor's protocol ID
- R01HS019341-01
- Acronym
- PATIENT
- Status last verified
- Feb 2017
- First submitted
- 30 Nov 2010
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: At the request of AHRQ we did not create a formal public data release.
Publications
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.
PubMed 25811824Smith 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.
PubMed 27021751Owen-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.
PubMed 27352409
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)
- ClinicalTrials.gov ID
- NCT01251757
- Acronym / sponsor ID
- PATIENT / R01HS019341-01
- Conditions
- Diabetes Mellitus, Cardiovascular Disease
- Keywords
- diabetes, cardiovascular disease, randomized clinical trial, medication adherence, health information technology, adult, telephone calls, IVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,752 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Kaiser Foundation Hospitals, Center for Health Research, Johns Hopkins University, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UC) | No intervention | –Participants in this arm received their usual care with no restrictions. |
| Interactive Voice Recognition (IVR) | Active comparator | Other: Interactive Voice Recognition (IVR) phone callsautomated phone calls |
| Enhanced IVR (IVR+) | Active comparator | Other: Interactive Voice Recognition (IVR) phone calls, Other: Educational mailings and follow-up for nonadherenceautomated phone calls \& Educational mailings and follow-up for nonadherence |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Voice Recognition (IVR) phone callsAlso: automated phone callsThe 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. | Other | Enhanced IVR (IVR+), Interactive Voice Recognition (IVR) |
| Educational mailings and follow-up for nonadherenceAlso: mail follow-up for nonadherence, educational mailingsParticipants 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. | Other | Enhanced IVR (IVR+) |
Primary outcome
Adherence to Statins
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Percentage With Good (>80%) Statin Adherence
Time frame: 12 months post randomization
Percentage With Good (>80%) ACEI/ARB Adherence
Time frame: 12 months post randomization
Systolic Blood Pressure (SBP)
Time frame: 12-months post randomization
Percentage With Good (<140/90 mmHg) Blood Pressure Control
Time frame: 12 months post randomization
Post Intervention Low Density Lipoprotein (LDL) Level
Time frame: 12 months post randomization
Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control
Time frame: 12 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25811824Vollmer 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.
- Results publication: PubMed 27021751Smith 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.
- Results publication: PubMed 27352409Owen-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.
- Individual participant dataSharing planned: No. At the request of AHRQ we did not create a formal public data release.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William M Vollmer, PhD principal investigator
Center for Health Research, Kaiser Permanente Northwest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Voice Recognition (IVR) phone calls and Educational mailings and follow-up for nonadherence in people with Diabetes Mellitus and Cardiovascular Disease, run by Kaiser Permanente at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Statins (time frame: 12 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251757, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.