Coronary Heart Disease
Conditions
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.
Interventions
BEHAVIORALStandard Treatment
BEHAVIORALMI and Medication review
Sponsors
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Göran Petersson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C) | 16 months | According to Swedish guidelines the goal is \< 1,8mmol/L or at least 50% reduction from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) | 16 months | 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 | 16 months | Self-reported adherence according to Morisky-8-Item Adherence Scale |
| Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA) | 16 months | 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 | 16 months | 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 | 16 months | 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 | 16 months | As registered in the Electronic Health Record |
| Changes in Quality of Life | 16 months | The Heart QoL instrument |
| Number of Cardiovascular Re-admissions and Emergency Department visits | 16 months | According to the Health Care register of Kalmar County |
Other
| Measure | Time frame | Description |
|---|---|---|
| Process measure: What was delivered in the Medication review | 12 months, only intervention group | Number and type of drug-related problems, as categorized by Cipolle and Strand. And documented effects of any actions taken on drug-related problems. |
| Process measure: Quality of MI, for a random sample of 20 % of consultations | 12 months | According to MITI 4.2.1 |
| Process measure: Beliefs about medicines - percent of patients per category | 16 months | 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. |
| Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD. | 16 months, for the last 100 patients to be included. | 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. |
| Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years | 16 months | Quality adjusted life years estimated by the re-admissions and quality of Life using Euroqol EQ-5D-5L |
| Process measure: Quality of prescribing, for a random sample of 20 % of patients | 6 months | According to Medication Assessment Tool for secondary prevention of Coronary Heart disease |
| Process measure: Intervention experienced by patients | 12 months | Qualitative interview study of 8-15 patients with negative beliefs about medicines at baseline. Analyzed with content analysis. |
Countries
Sweden
Outcome results
None listed