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Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Saskatchewan Ministry of Health
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01509014
First received: January 9, 2012
Last updated: January 11, 2012
Last verified: January 2012
History of Changes
  Purpose

Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence.

The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.


Condition Intervention
Statin Therapy
Adherence
 Behavioral: CPATCH intervention to support statin adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All statin dispensations are captured by the prescription drug plan database. Mean adherence will be measured using the proportion of days covered (sum of days supply for statin prescriptions during study period divided by the number of days of observation). PDC will be adjusted for any days subject was hospitalized during study period.,


Secondary Outcome Measures:
  • Proportion of new statin users with adherence greater than or equal to 80% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Persistence with statin use among patients with a minimum of 12 months of follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2250
Study Start Date: March 2010
Estimated Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacy Intervention Arm
All patients receiving statins from pharmacies allocated to the pharmacist intervention arm of the study
 Behavioral: CPATCH intervention to support statin adherence
Routine identification of new statin users (first year of therapy), consistent assessment of barriers to adherence at every dispensation for these patients, reassurance about efficacy and safety, and proactive response to identified adherence barriers.
No Intervention: Usual Care
Pharmacies not allocated to the intervention arm will serve as the control. They received no training on the CPATCH intervention and provide usual care to patients at their pharmacy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pharmacies must fill at least 85 statin prescriptions in a six-week period
  • CPATCH intervention was given priority over other study initiatives offered by the pharmacy
  • All members of pharmacy staff provided informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509014

Locations
Canada, Saskatchewan
College of Pharmacy and Nutrition, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7n 5C9
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Ministry of Health
Merck Frosst Canada Ltd.
  More Information

Publications:

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01509014     History of Changes
Obsolete Identifiers: NCT00971412
Other Study ID Numbers: NCT00971412
Study First Received: January 9, 2012
Last Updated: January 11, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Statins
Adherence
Pharmacists

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013