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

H

Hospital Pharmacy of North Norway Trust

Status

Completed

Conditions

Coronary Heart Disease

Treatments

Other: Pharmacist follow-up

Study type

Interventional

Funder types

Other

Identifiers

NCT01115608
SHAN-001

Details and patient eligibility

About

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.

Full 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

Enrollment

102 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Pharmacist follow-up
Experimental group
Description:
The patients will receive pharmaceutical follow-up during one year after discharge from the hospital. Three meetings are arranged, one at discharge, one after three months and the last after one year. Patients will be called up for arrangement of "consultation". Written information concerning drugs used will be supplied.
Treatment:
Other: Pharmacist follow-up
Control group
No Intervention group
Description:
The control group receives no follow-up from the pharmacist, but will after one year, when they are out of the study, receive one follow-up visit and drug review.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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