Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pharmacist follow-up
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Heart Disease focused on measuring Preventive Health Services
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
Sites / Locations
- Hospital Pharmacy of North Norway Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacist follow-up
Control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01115608
First Posted
April 29, 2010
Last Updated
June 25, 2020
Sponsor
Hospital Pharmacy of North Norway Trust
Collaborators
University of Tromso
1. Study Identification
Unique Protocol Identification Number
NCT01115608
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2009 (Actual)
Primary Completion Date
June 30, 2011 (Actual)
Study Completion Date
June 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Pharmacy of North Norway Trust
Collaborators
University of Tromso
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Preventive Health Services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist follow-up
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pharmacist follow-up
Intervention Description
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 Outcome Measure Information:
Title
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
Description
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.
Time Frame
At baseline (both arms)
Title
Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations)
Description
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.
Time Frame
After one year (both arms)
Secondary Outcome Measure Information:
Title
Drug related problems
Description
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.
Time Frame
At inclusion, after three months and after one year.
Title
Hospitalisation
Description
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.
Time Frame
After one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trude Giverhaug, Dr.Scient.
Organizational Affiliation
Hospital Pharmacy of North Norway Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Pharmacy of North Norway Trust
City
Tromsø
ZIP/Postal Code
9020
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared
Links:
URL
https://helseforskning.etikkom.no/?_ikbLanguageCode=us
Description
Regional Committees for Medical and Health Research Ethics (REK)
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf
Description
Published Article
Learn more about this trial
Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients
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