Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients

Coronary Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115608
• Other study ID #: SHAN-001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2009
• Est. completion date: June 30, 2011

Study information

• Verified date: June 2020
• Source: Hospital Pharmacy of North Norway Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 30, 2011
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Pharmacist follow-up
Drug review, drug conversation and written drug information. Follow-up concerning therapeutic goals and cooperation with the patient and the patient's GP to achieve these.

Locations

Country	Name	City	State
Norway	Hospital Pharmacy of North Norway Trust	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Pharmacy of North Norway Trust	University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)	MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.	At baseline (both arms)
Primary	Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)	MAT-CHDsp includes 20 review criteria assessing both appropriateness of drug prescribing, appropriateness of dose adjustments/change of drugs and appropriateness of information concerning life-style modifications. Achievment of therapeutic goals concerning lipids, blood pressure and blood glucose is also measured.	After one year (both arms)
Secondary	Drug related problems	Medication reviews often reveals safety issues concerning the drug regime, except from the primary outcome measures. THese are noted and will be assessed and tried solved during follow-up in close cooperation with the GP.	At inclusion, after three months and after one year.
Secondary	Hospitalisation	Data will be collected, both for the study group and for the control group, concerning hospitalisation during the year included in the study. The groups will be compared.	After one year

External Links

•   Norwegian Social Science Data Services (NSD)
•   Published Article
•   Regional Committees for Medical and Health Research Ethics (REK)