Clinical trial NCT02102503: Motivational Interviewing and Medication Review in Coronary Heart Disease
Official title: Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: The Kamprad Family Foundation for Entrepreneurship, Research & Charity
First posted: 2014-04-03
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)
timeFrame: 16 months
Secondary outcomes:
measure: Percentage of patients adherent to cholesterol lowering treatment
timeFrame: 16 months
measure: Percentage of patients adherent to cholesterol lowering treatment
timeFrame: 16 months
measure: Percentage of patients adherent to cholesterol lowering treatment
timeFrame: 16 months
measure: Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)
timeFrame: 16 months
measure: Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)
timeFrame: 16 months
measure: Percentage of patients adherent to preventive medication: P2Y12-antagonist
timeFrame: 16 months
measure: Percentage of patients adherent to preventive medication: Beta-blocker
timeFrame: 16 months
measure: Percentage of patients with Systolic Blood Pressure <140
timeFrame: 16 months
measure: Changes in Quality of Life
timeFrame: 16 months
measure: Number of Cardiovascular Re-admissions and Emergency Department visits
timeFrame: 16 months
Other outcomes:
measure: Process measure: Quality of prescribing, for a random sample of 20 % of patients
timeFrame: 6 months
measure: Process measure: What was delivered in the Medication review
timeFrame: 12 months, only intervention group
measure: Process measure: Quality of MI, for a random sample of 20 % of consultations
timeFrame: 12 months
measure: Process measure: Beliefs about medicines - percent of patients per category
timeFrame: 16 months
measure: Process measure: Intervention experienced by patients
timeFrame: 12 months
measure: Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD.
timeFrame: 16 months, for the last 100 patients to be included.
measure: Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years
timeFrame: 16 months
Locations:
city: Kalmar
country: Sweden
facility: Kalmar County Hospital
Study officials:
affiliation: Linnaeus University
name: Göran Petersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.