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

NCT ID: NCT01115608

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-01

Study Completion Date

2011-06-30

Brief Summary

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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

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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

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pharmacist follow-up

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.

Group Type EXPERIMENTAL

Pharmacist follow-up

Intervention Type OTHER

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tromso

OTHER

Sponsor Role collaborator

Hospital Pharmacy of North Norway Trust

OTHER

Sponsor Role lead

Responsible Party

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Beate Hennie Garcia, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Trude Giverhaug, Dr.Scient.

Role: STUDY_CHAIR

Hospital Pharmacy of North Norway Trust

Locations

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Hospital Pharmacy of North Norway Trust

Tromsø, , Norway

Site Status

Countries

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Norway

Related Links

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Other Identifiers

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SHAN-001

Identifier Type: -

Identifier Source: org_study_id

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