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Motivational Interviewing and Medication Review in Coronary Heart Disease

Not Applicable
Completed
Conditions
Coronary Heart Disease
Interventions
Behavioral: Standard Treatment
Behavioral: MI and Medication review
Registration Number
NCT02102503
Lead Sponsor
Göran Petersson
Brief Summary

Low medication adherence in patients with coronary heart disease increases mortality.

This study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.

Detailed Description

The study will investigate the effects of medication review and Motivational Interviewing (MI) on patients with Coronary Heart Disease (CHD). Clinical pharmacists competent in MI and cardiology will conduct medication interviews and medication reviews at the outpatient clinic. The intervention will continue during 9 months, with interviews and reviews as needed.

Follow-up of results will take place 16 months after inclusion (corresponding to 4 months after the end of intervention).

The MI-Component will be quality assured by MITI 4.2-coding (Motivational Interviewing Treatment Integrity). The study will investigate effects on clinical outcomes, medication adherence, patients´ beliefs about medicines and quality of life.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
417
Inclusion Criteria
  • Admitted for angiography
  • Verified Coronary Artery Disease (ICD-10 I20-I21)
  • Planned for follow up at the out-patient clinic (standard treatment)
  • Swedish speaking
Exclusion Criteria
  • Cognitive impairment or any othe condition making interview or phone calls impossible.
  • Non-participation in the standard follow-up
  • Prior participation in this study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MI and Medication reviewStandard TreatmentThe intervention starts three months post-discharge after the standard treatment at the out-patients clinic. A medication review focused on cardiovascular drugs, and a counselling session with a clinical pharmacist using Motivational Interviewing (MI)-approach, and a follow-up phone call two weeks later. For patients with negative beliefs about medicines, three additional MI-sessions in clinic or by phone are planned together with the patient. Irrespective of beliefs the intervention ends with a second medication review and counselling session, which is coordinated with the 12-months post-discharge follow-up in primary care.
Standard treatmentStandard TreatmentStandard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.
MI and Medication reviewMI and Medication reviewThe intervention starts three months post-discharge after the standard treatment at the out-patients clinic. A medication review focused on cardiovascular drugs, and a counselling session with a clinical pharmacist using Motivational Interviewing (MI)-approach, and a follow-up phone call two weeks later. For patients with negative beliefs about medicines, three additional MI-sessions in clinic or by phone are planned together with the patient. Irrespective of beliefs the intervention ends with a second medication review and counselling session, which is coordinated with the 12-months post-discharge follow-up in primary care.
Primary Outcome Measures
NameTimeMethod
Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)16 months

According to Swedish guidelines the goal is \< 1,8mmol/L or at least 50% reduction from baseline.

Secondary Outcome Measures
NameTimeMethod
Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)16 months

Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.

Percentage of patients adherent to preventive medication: P2Y12-antagonist16 months

Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.

Percentage of patients with Systolic Blood Pressure <14016 months

As registered in the Electronic Health Record

Changes in Quality of Life16 months

The Heart QoL instrument

Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)16 months

Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.

Percentage of patients adherent to cholesterol lowering treatment16 months

Prescription refill according to the Swedish Prescribed Drug Register, Percent Day Covered (PDC) during follow-up period, 80% is set as the cut-off for adherence.

Percentage of patients adherent to preventive medication: Beta-blocker16 months

Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.

Number of Cardiovascular Re-admissions and Emergency Department visits16 months

According to the Health Care register of Kalmar County

Trial Locations

Locations (1)

Kalmar County Hospital

🇸🇪

Kalmar, Sweden

Kalmar County Hospital
🇸🇪Kalmar, Sweden
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