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

NCT01115608 | Completed

• 1 other identifier: SHAN-001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Preventive Health Services

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline (both arms)

• 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.

  After one year (both arms)

Secondary Outcomes (2)

• Drug related problems

  At inclusion, after three months and after one year.

• Hospitalisation

  After one year

Study Arms (2)

Pharmacist follow-up

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Pharmacist follow-up

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Pharmacy of North Norway Trust: lead
• University of Tromso: collaborator

Study Sites (1)

Hospital Pharmacy of North Norway Trust

Tromsø, 9020, Norway

Location

Related Links

• Published Article

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Trude Giverhaug, Dr.Scient.

  Hospital Pharmacy of North Norway Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 4, 2010
• Study Start: February 1, 2009
• Primary Completion: June 30, 2011
• Study Completion: June 30, 2011
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)