An interventional study of Standard Treatment and MI and Medication review in Coronary Heart Disease, sponsored by Göran Petersson. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-09.
Sponsored by Göran Petersson · Not applicable, Interventional, and Supportive care
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.
2,866 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's enrollment of 417 is above the median of 124 across 1,601 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →This is the only study on the registry with Göran Petersson as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: Standard Treatment · Behavioral: MI and Medication review
Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.
Behavioral: Standard Treatment
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.
Time frame: 16 months
Percentage of patients adherent to cholesterol lowering treatment
Self-reported adherence according to Morisky-8-Item Adherence Scale
Time frame: 16 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 months
Percentage of patients with Systolic Blood Pressure <140
As registered in the Electronic Health Record
Time frame: 16 months
Changes in Quality of Life
The Heart QoL instrument
Time frame: 16 months
Number of Cardiovascular Re-admissions and Emergency Department visits
According to the Health Care register of Kalmar County
Time frame: 16 months
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
Time frame: 6 months
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.
Time frame: 12 months, only intervention group
Process measure: Quality of MI, for a random sample of 20 % of consultations
According to MITI 4.2.1
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 16 months
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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