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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hospital Pharmacy of North Norway Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Tromso
Information provided by:
Hospital Pharmacy of North Norway Trust
ClinicalTrials.gov Identifier:
NCT01115608
First received: April 29, 2010
Last updated: May 3, 2011
Last verified: April 2011
  Purpose

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 Intervention
Coronary Heart Disease
Other: Pharmacist follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Hospital Pharmacy of North Norway Trust:

Primary Outcome Measures:
  • Adherence to MAT-CHDsp (medication assessment tool based on guideline recommendations) [ Time Frame: At baseline (both arms) ] [ Designated as safety issue: No ]
    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) [ Time Frame: After one year (both arms) ] [ Designated as safety issue: No ]
    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 [ Time Frame: At inclusion, after three months and after one year. ] [ Designated as safety issue: No ]
    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 [ Time Frame: After one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Trude Giverhaug, Hospital Pharmacy of North Norway Trust
ClinicalTrials.gov Identifier: NCT01115608     History of Changes
Other Study ID Numbers: SHAN-001
Study First Received: April 29, 2010
Last Updated: May 3, 2011
Health Authority: Norway: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 01, 2014