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| Name | Class |
|---|---|
| The Kamprad Family Foundation for Entrepreneurship, Research & Charity | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI and Medication review | Experimental | 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. |
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| Standard treatment | Active Comparator | Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Treatment | Behavioral |
| ||
| MI and Medication review |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Process measure: What was delivered in the Medication review |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Göran Petersson, MD, PhD | Linnaeus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kalmar County Hospital | Kalmar | 39182 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34334142 | Derived | 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. | |
| 29463490 | Derived | 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. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000090143 | Medication Review |
| ID | Term |
|---|---|
| D008509 | Medication Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010346 | Patient Care Management |
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| Behavioral |
|
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 |
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 |
| Process measure: Quality of MI, for a random sample of 20 % of consultations | According to MITI 4.2.1 | 12 months |
| 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 |
| 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 |
| 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. |
| 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 |