Clinical trial NCT01115608: Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients
Official title: Development of a Standardized Clinical Pharmacist Service for Patients Discharged From Hospital. Measurement of Drug Prescribing Quality in Secondary Prevention of Coronary Heart Disease Utilizing a Medication Assessment Tool (MAT-CHDsp)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Preventive Health Services
Lead sponsor: Hospital Pharmacy of North Norway Trust
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2010-05-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48 intervention group patients and 46 controls.

Appropriate prescribing was high, but therapy goal achievement was low in both study groups throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end compared to the control group, 78.1% vs. 61.4%, P \< 0.001. The difference was mainly due to an increased documentation of lifestyle advices in intervention group patients.

No significant improvements in biomedical risk factors were observed in favor of the intervention group, possible due to an underpowered study. Conclusion The clinical pharmacist-led follow-up program significantly increased documented lifestyle advices defined in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in biomedical risk factor measures in favor of the intervention group. Even if prescribing was high, therapy goal achievement was low in both study groups. Changes to the follow-up program are warranted, in addition to a larger, adequately powered study, before implementation in standard patient care can be recommended.

Detailed description: Find published article in Pharm Pract (Granada). 2015 Apr-Jun; 13(2): 575. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf

Eligibility criteria: Inclusion Criteria:

* established coronary heart disease
* age 18 - 80 years
* patients living in the three nearby communities Tromsoe, Balsfjord and Karlsoey, this because they need to see the pharmacist personally.

Exclusion Criteria:

* patients living in nursing homes
* patients included in NORstent, another trial including patients at the same department
* patients already receiving pharmaceutical follow-up elsewhere
* cancer patients

Primary outcomes:
measure: Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
timeFrame: At baseline (both arms)
measure: Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
timeFrame: After one year (both arms)
Secondary outcomes:
measure: Drug related problems
timeFrame: At inclusion, after three months and after one year.
measure: Hospitalisation
timeFrame: After one year
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Hospital Pharmacy of North Norway Trust
Study officials:
affiliation: Hospital Pharmacy of North Norway Trust
name: Trude Giverhaug, Dr.Scient.
role: STUDY_CHAIR
References: