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NCT Number: NCT02102503

Motivational Interviewing and Medication Review in Coronary Heart Disease

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kalmar County Hospital

Kalmar, 39182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard treatment

Behavioral

MI and Medication review

Behavioral

Primary outcomes

  1. Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)

    Time frame: 16 months

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

Secondary outcomes

  1. Percentage of patients adherent to cholesterol lowering treatment

    Time frame: 16 months

    Self-reported adherence according to Morisky-8-Item Adherence Scale

  2. Percentage of patients adherent to cholesterol lowering treatment

    Time frame: 16 months

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

  3. Percentage of patients adherent to cholesterol lowering treatment

    Time frame: 16 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.

  4. Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)

    Time frame: 16 months

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

  5. Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)

    Time frame: 16 months

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

  6. Percentage of patients adherent to preventive medication: P2Y12-antagonist

    Time frame: 16 months

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

  7. Percentage of patients adherent to preventive medication: Beta-blocker

    Time frame: 16 months

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

  8. Percentage of patients with Systolic Blood Pressure <140

    Time frame: 16 months

    As registered in the Electronic Health Record

  9. Changes in Quality of Life

    Time frame: 16 months

    The Heart QoL instrument

  10. Number of Cardiovascular Re-admissions and Emergency Department visits

    Time frame: 16 months

    According to the Health Care register of Kalmar County

Other outcomes

  1. Process measure: Quality of prescribing, for a random sample of 20 % of patients

    Time frame: 6 months

    According to Medication Assessment Tool for secondary prevention of Coronary Heart disease

  2. Process measure: What was delivered in the Medication review

    Time frame: 12 months, only intervention group

    Number and type of drug-related problems, as categorized by Cipolle and Strand. And documented effects of any actions taken on drug-related problems.

  3. Process measure: Quality of MI, for a random sample of 20 % of consultations

    Time frame: 12 months

    According to MITI 4.2.1

  4. Process measure: Beliefs about medicines - percent of patients per category

    Time frame: 16 months

    Beliefs about medicines questionnaire (BMQ-S10), categories: accepting, ambivalent, neutral, skeptical. Also temporal cahnges in both Groups and Changes in each item of the subscales.

  5. Process measure: Intervention experienced by patients

    Time frame: 12 months

    Qualitative interview study of 8-15 patients with negative beliefs about medicines at baseline. Analyzed with content analysis.

  6. Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD.

    Time frame: 16 months, for the last 100 patients to be included.

    Open question: What is you opinion of the follow-up care after your heart disease?" Analysed with qualitative content analysis separetly for Control and intervention group patients.

  7. Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years

    Time frame: 16 months

    Quality adjusted life years estimated by the re-admissions and quality of Life using Euroqol EQ-5D-5L

Sponsors and collaborators

Lead sponsor

Göran Petersson

Other

Collaborators

  • The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Registry information

Official study title

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

Acronym: MIMeRiC

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2014
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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