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Completed

NCT Number: NCT01115608

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pharmacy of North Norway Trust

Tromsø, 9020, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist follow-up

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.

Primary outcomes

  1. Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)

    Time frame: At baseline (both arms)

    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.

  2. Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)

    Time frame: After one year (both arms)

    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.

Secondary outcomes

  1. Drug related problems

    Time frame: At inclusion, after three months and after one year.

    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.

  2. Hospitalisation

    Time frame: After one year

    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.

Sponsors and collaborators

Lead sponsor

Hospital Pharmacy of North Norway Trust

Other

Collaborators

  • University of Tromso

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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