Motivational Interviewing and Medication Review in Coronary Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Standard Treatment
* Behavioral: MI and Medication review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI and Medication review<br>The 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. | Behavioral: Standard Treatment<br> <br> Behavioral: MI and Medication review<br> <br> |
| Active Comparator: Standard treatment<br>Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months. | Behavioral: Standard Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C) | According to Swedish guidelines the goal is < 1,8mmol/L or at least 50% reduction from baseline. | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients adherent to cholesterol lowering treatment | Self-reported adherence according to Morisky-8-Item Adherence Scale | 16 months | 
| Percentage of patients adherent to cholesterol lowering treatment | Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence. | 16 months | 
| Percentage of patients adherent to cholesterol lowering treatment | 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. | 16 months | 
| Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) | Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence. | 16 months | 
| Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA) | Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence. | 16 months | 
| Percentage of patients adherent to preventive medication: P2Y12-antagonist | Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence. | 16 months | 
| Percentage of patients adherent to preventive medication: Beta-blocker | Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence. | 16 months | 
| Percentage of patients with Systolic Blood Pressure <140 | As registered in the Electronic Health Record | 16 months | 
| Changes in Quality of Life | The Heart QoL instrument | 16 months | 
| Number of Cardiovascular Re-admissions and Emergency Department visits | According to the Health Care register of Kalmar County | 16 months |