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

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ClinicalTrials.gov Identifier: NCT01115608
Recruitment Status : Unknown
Verified April 2011 by Hospital Pharmacy of North Norway Trust.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2010
Last Update Posted : May 4, 2011
Sponsor:
Collaborator:
University of Tromso
Information provided by:
Hospital Pharmacy of North Norway Trust

Brief Summary:

It is well known that secondary prevention is very important for patients with established coronary heart disease, it reduces both mortality and morbidity. Pharmacists in Norway are not routinely involved in follow-up of this patient group, but many studies have shown that involvement of a pharmacist have a positive influence in achieving therapy goals for e.g. blood pressure, lipids and blood sugar.

The investigators hypothesis is that follow-up by a clinical pharmacist after hospital discharge will increase adherence to clinical guideline recommendations and increase achievement of specific therapy goals for blood pressure, lipids and glucose in patients with established CHD. The investigators plan to include patients with established CHD, discharged from hospital after admission to the cardiology department.

Patients included (18-80 years) will be randomized to an intervention and a control group. In addition to ordinary health care, the intervention group receives follow-up from a clinical pharmacist during one year with three meeting points, at discharge, after three months and after one year. The control group receives only ordinary health care, but are called in after one year for data collection. Patients living in nursing homes, patients already receiving pharmaceutical follow-up elsewhere and cancer patients are excluded from the study. Only patients living in the area of Tromsoe and nearby is included, as they need to physically see the pharmacist.

The follow-up include medication review and subsequently solving of drug related problems in addition to drug information and monitoring of clinical therapy goals relevant for secondary prevention of CHD.

The main outcome measures is adherence to specified review criteria defined in a medication assessment tool (MAT-CHDsp) based on recommendations from the European Society of Cardiology. Other outcome measures include 1)number of drug related problems identified and solved, 2) hospital admissions, 3)deaths.


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Other: Pharmacist follow-up Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : February 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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.
No Intervention: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115608


Locations
Norway
Hospital Pharmacy of North Norway Trust
Tromsø, Norway, 9020
Sponsors and Collaborators
Hospital Pharmacy of North Norway Trust
University of Tromso
Investigators
Study Chair: Trude Giverhaug, Dr.Scient. Hospital Pharmacy of North Norway Trust

Additional Information:
Responsible Party: Trude Giverhaug, Hospital Pharmacy of North Norway Trust
ClinicalTrials.gov Identifier: NCT01115608     History of Changes
Other Study ID Numbers: SHAN-001
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: April 2011

Keywords provided by Hospital Pharmacy of North Norway Trust:
Preventive Health Services

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases