Motivational Interviewing and Medication Review in Coronary Heart Disease

Coronary Heart Disease Clinical Trial

— MIMeRiC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102503
• Other study ID #: GLAS-1-2013
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Linneaus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Standard Treatment

• MI and Medication review

Locations

Country	Name	City	State
Sweden	Kalmar County Hospital	Kalmar

Sponsors (2)

Lead Sponsor	Collaborator
Göran Petersson	The Kamprad Family Foundation for Entrepreneurship, Research and Charity

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process measure: Quality of prescribing, for a random sample of 20 % of patients	According to Medication Assessment Tool for secondary prevention of Coronary Heart disease	6 months
Other	Process measure: What was delivered in the Medication review	Number and type of drug-related problems, as categorized by Cipolle and Strand. And documented effects of any actions taken on drug-related problems.	12 months, only intervention group
Other	Process measure: Quality of MI, for a random sample of 20 % of consultations	According to MITI 4.2.1	12 months
Other	Process measure: Beliefs about medicines - percent of patients per category	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.	16 months
Other	Process measure: Intervention experienced by patients	Qualitative interview study of 8-15 patients with negative beliefs about medicines at baseline. Analyzed with content analysis.	12 months
Other	Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD.	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.	16 months, for the last 100 patients to be included.
Other	Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years	Quality adjusted life years estimated by the re-admissions and quality of Life using Euroqol EQ-5D-5L	16 months
Primary	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	Percentage of patients adherent to cholesterol lowering treatment	Self-reported adherence according to Morisky-8-Item Adherence Scale	16 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients with Systolic Blood Pressure <140	As registered in the Electronic Health Record	16 months
Secondary	Changes in Quality of Life	The Heart QoL instrument	16 months
Secondary	Number of Cardiovascular Re-admissions and Emergency Department visits	According to the Health Care register of Kalmar County	16 months