Community Pharmacy Assisting in Total Cardiovascular Health

Adherence Clinical Trial

— CPATCH  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01509014
• Other study ID #: NCT00971412
• Status: Active, not recruiting
• Phase: N/A
• First received: January 9, 2012
• Last updated: January 11, 2012
• Start date: March 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00971412

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2250
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adherence
• Statin Therapy

Intervention

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.

Locations

Country	Name	City	State
Canada	College of Pharmacy and Nutrition, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Merck Frosst Canada Ltd., Saskatchewan Ministry of Health

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Evans CD, Eurich DT, Taylor JG, Remillard AJ, Shevchuk YM, Blackburn DF. A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study. Trials. 2010 Jul 8;11:76. doi: 10.1186/1745-6215-11-76. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription	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.,	6 months	No
Secondary	Proportion of new statin users with adherence greater than or equal to 80%		6 months	No
Secondary	Persistence with statin use among patients with a minimum of 12 months of follow-up		6 months	No