Community Pharmacy Assisting in Total Cardiovascular Health

NCT01509014 | Unknown

• 1 other identifier: NCT00971412
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Statin Therapy; Adherence

Keywords

Statins; Adherence; Pharmacists

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Proportion of new statin users with adherence greater than or equal to 80%

  6 months

• Persistence with statin use among patients with a minimum of 12 months of follow-up

  6 months

Study Arms (2)

Pharmacy Intervention Arm

EXPERIMENTAL

All patients receiving statins from pharmacies allocated to the pharmacist intervention arm of the study

Behavioral: CPATCH intervention to support statin adherence

Usual Care

NO INTERVENTION

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.

Interventions

CPATCH intervention to support statin adherence BEHAVIORAL

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.

Pharmacy Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Ministry of Health, Saskatchewan: collaborator
• Merck Frosst Canada Ltd.: collaborator

Study Sites (1)

College of Pharmacy and Nutrition, University of Saskatchewan

Saskatoon, Saskatchewan, S7n 5C9, Canada

Location

Related 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.

  PMID: 20615235 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

CA (1)