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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Standard Treatment
MI and Medication review
Sponsored by
Göran Petersson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kalmar County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MI and Medication review

Standard treatment

Arm Description

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.

Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of patients adherent to cholesterol lowering treatment
Self-reported adherence according to Morisky-8-Item Adherence Scale
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.
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.
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.
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.
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.
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.
Percentage of patients with Systolic Blood Pressure <140
As registered in the Electronic Health Record
Changes in Quality of Life
The Heart QoL instrument
Number of Cardiovascular Re-admissions and Emergency Department visits
According to the Health Care register of Kalmar County

Full Information

First Posted
March 31, 2014
Last Updated
August 8, 2018
Sponsor
Göran Petersson
Collaborators
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
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1. Study Identification

Unique Protocol Identification Number
NCT02102503
Brief Title
Motivational Interviewing and Medication Review in Coronary Heart Disease
Acronym
MIMeRiC
Official Title
Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Göran Petersson
Collaborators
The Kamprad Family Foundation for Entrepreneurship, Research & Charity

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI and Medication review
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment
Intervention Type
Behavioral
Intervention Name(s)
MI and Medication review
Primary Outcome Measure Information:
Title
Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)
Description
According to Swedish guidelines the goal is < 1,8mmol/L or at least 50% reduction from baseline.
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Percentage of patients adherent to cholesterol lowering treatment
Description
Self-reported adherence according to Morisky-8-Item Adherence Scale
Time Frame
16 months
Title
Percentage of patients adherent to cholesterol lowering treatment
Description
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Time Frame
16 months
Title
Percentage of patients adherent to cholesterol lowering treatment
Description
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.
Time Frame
16 months
Title
Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)
Description
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Time Frame
16 months
Title
Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)
Description
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Time Frame
16 months
Title
Percentage of patients adherent to preventive medication: P2Y12-antagonist
Description
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Time Frame
16 months
Title
Percentage of patients adherent to preventive medication: Beta-blocker
Description
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Time Frame
16 months
Title
Percentage of patients with Systolic Blood Pressure <140
Description
As registered in the Electronic Health Record
Time Frame
16 months
Title
Changes in Quality of Life
Description
The Heart QoL instrument
Time Frame
16 months
Title
Number of Cardiovascular Re-admissions and Emergency Department visits
Description
According to the Health Care register of Kalmar County
Time Frame
16 months
Other Pre-specified Outcome Measures:
Title
Process measure: Quality of prescribing, for a random sample of 20 % of patients
Description
According to Medication Assessment Tool for secondary prevention of Coronary Heart disease
Time Frame
6 months
Title
Process measure: What was delivered in the Medication review
Description
Number and type of drug-related problems, as categorized by Cipolle and Strand. And documented effects of any actions taken on drug-related problems.
Time Frame
12 months, only intervention group
Title
Process measure: Quality of MI, for a random sample of 20 % of consultations
Description
According to MITI 4.2.1
Time Frame
12 months
Title
Process measure: Beliefs about medicines - percent of patients per category
Description
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.
Time Frame
16 months
Title
Process measure: Intervention experienced by patients
Description
Qualitative interview study of 8-15 patients with negative beliefs about medicines at baseline. Analyzed with content analysis.
Time Frame
12 months
Title
Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD.
Description
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.
Time Frame
16 months, for the last 100 patients to be included.
Title
Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years
Description
Quality adjusted life years estimated by the re-admissions and quality of Life using Euroqol EQ-5D-5L
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Göran Petersson, MD, PhD
Organizational Affiliation
Linnaeus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalmar County Hospital
City
Kalmar
ZIP/Postal Code
39182
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34334142
Citation
Ostbring MJ, Eriksson T, Petersson G, Hellstrom L. Effects of a pharmaceutical care intervention on clinical outcomes and patient adherence in coronary heart disease: the MIMeRiC randomized controlled trial. BMC Cardiovasc Disord. 2021 Aug 1;21(1):367. doi: 10.1186/s12872-021-02178-0.
Results Reference
derived
PubMed Identifier
29463490
Citation
Ostbring MJ, Eriksson T, Petersson G, Hellstrom L. Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life. JMIR Res Protoc. 2018 Feb 20;7(2):e57. doi: 10.2196/resprot.8659.
Results Reference
derived

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Motivational Interviewing and Medication Review in Coronary Heart Disease

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