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Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)

This study has been completed.
Sponsor:
Collaborators:
Kaiser Foundation Hospitals, Center for Health Research
Johns Hopkins University
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01251757
First received: November 30, 2010
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus
Cardiovascular Disease
Other: Interactive Voice Recognition (IVR) phone calls
Other: Educational mailings and follow-up for nonadherence
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Percentage With Good (>80%) Statin Adherence [ Time Frame: 12 months post randomization ]
    Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.

  • Percentage With Good (>80%) ACEI/ARB Adherence [ Time Frame: 12 months post randomization ]
    Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.

  • Systolic Blood Pressure (SBP) [ Time Frame: 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 [ Time Frame: 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.

  • Post Intervention Low Density Lipoprotein (LDL) Level [ Time Frame: 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 (<=100mg/dL) Low Density Lipoprotein (LDL) Control [ Time Frame: 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.


Enrollment: 21752
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care (UC)
Participants in this arm received their usual care with no restrictions.
Active Comparator: Interactive Voice Recognition (IVR)
automated phone calls
Other: Interactive 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.
Other Name: automated phone calls
Active Comparator: Enhanced IVR (IVR+)
automated phone calls & Educational mailings and follow-up for nonadherence
Other: Interactive 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.
Other Name: automated phone calls
Other: Educational 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.
Other Names:
  • mail follow-up for nonadherence
  • educational mailings

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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251757

Locations
United States, Georgia
Center for Health Research, Kaiser Permanente Southeast
Atlanta, Georgia, United States, 30305
United States, Hawaii
Center for Health Research, Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96817
United States, Oregon
Center for Health Research, Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Kaiser Foundation Hospitals, Center for Health Research
Johns Hopkins University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: William M Vollmer, PhD Center for Health Research, Kaiser Permanente Northwest
  More Information

Additional Information:
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01251757     History of Changes
Other Study ID Numbers: R01HS019341-01 
Study First Received: November 30, 2010
Results First Received: July 25, 2016
Last Updated: December 7, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: At the request of AHRQ we did not create a formal public data release.

Keywords provided by Kaiser Permanente:
diabetes
cardiovascular disease
randomized clinical trial
medication adherence
health information technology
adult
telephone calls
IVR

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 23, 2017