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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351676
Other study ID # EPICORE-2006-001
Secondary ID
Status Completed
Phase Phase 4
First received July 12, 2006
Last updated December 7, 2007
Start date February 2006
Est. completion date July 2007

Study information

Verified date February 2006
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during the drug therapy decision making process and promote optimal drug use by identifying and resolving actual and potential drug related problems. This study is designed to test this hypothesis, by assessing the impact of this intervention on evidence based, quality of drug therapy indicators, for patients admitted with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).


Description:

The overall goal of the COLLABORATE study is to improve processes of care and patient outcomes by optimizing drug therapy via a hospital pharmacy practice model that integrates clinical pharmacists into the patient care team.

The intervention consists of a clinical pharmacist assigned to the patient care team for the purpose of providing proactive clinical pharmacy services. The study pharmacist will be available during normal office hours 5 days per week to provide clarification of the patient's medication history, identify and resolve actual and potential patient specific drug related problems/issues, participate in patient care rounds, provide drug information to the patient care team, provide patient education and discharge medication counselling, and provide physician and/or nursing staff education. The anticipated pharmacist to patient ratio is approximately 1:20.

Control patients will receive usual care. Usual care consists of reactive clinical pharmacy services (i.e. drug related issues identified as orders are received, or by patient profile review) provided by a ward based, not team based, clinical pharmacist.


Recruitment information / eligibility

Status Completed
Enrollment 452
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Consecutive patients > 18 years of age admitted to participating internal and family medicine teams during the 1 year study period will be eligible to receive the pharmacist intervention. For the purposes of data analysis, patients with a most responsible or primary diagnosis of HF, COPD, CAP, T2DM, and CAD will be included.

Exclusion Criteria:

- Residence outside the Capital Health catchment

- Admitted for = 2 days

- Palliative care

- Transferred to another team

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Behavioral:
Integration of a team based clinical pharmacist

Drug:
Optimizing therapeutic treatments

Behavioral:
Optimizing processes of care


Locations

Country Name City State
Canada Grey Nuns Community Hospital Edmonton Alberta
Canada Royal Alexandra Hospital Edmonton Alberta
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Alberta Capital Health, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. in hospital No
Secondary Differences in condition-specific achievement of drug therapy quality indicators; in hospital No
Secondary Differences in 6 month hospital readmission rate; 6 months No
Secondary Differences in number, type, acceptance rate, and expected impact of all pharmacist interventions; in hospital No
Secondary Qualitative evaluation of the impact of the intervention via interviews with the participating pharmacists and physicians. in hospital No
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