Randomized Controlled Trial of Pharmacist-led Medication Review With Follow-up on Cardiovascular Older Adult Patients in Primary Care. POLARIS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Patients with controlled hypertension, type-2 diabetes or dyslipidemia
Study Overview
Brief Summary
Hypothesis: Medication Review with follow-up can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a cluster randomized controlled trial will be held in primary care centres of the public health system of Chile. Patients of the cardiovascular disease prevention program, older than 65 years and with poly pharmacy (more than 5 drugs) will be recruited. Control group will receive usual care and the intervention arm will have medication review consultations by a pharmacist every 4 months for one year. Clinical interventions will be made with physician authorisation. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy in the elderly, interview skills and educational techniques. A practice change facilitator will assist the pharmacist in any matters regarding the methodology and will asses barriers and facilitators to the implementation of the medication review with follow-up service. A personalised plan will be developed for every pharmacist. Clinical outcomes (blood pressure, HbA1c, LDL cholesterol, overall cardiovascular risk, among others), number of medications, adherence rate and health-related quality of life will be evaluated. A cost-utility analysis will be made through the health ministry of Chile perspective.
Detailed Description
This study was approved by the ethics committee from the Metropolitan Southeastern health service and the University of Technology Sydney (UTS)'s Human Research Ethics Committee (HREC). All patients are compelled to sign an informed consent document before the first interview, explaining that they can leave the study whenever they want without punishment or justification. All data will be coded and stored without any personal information, to comply with the Chilean law 19,628 for protection of personal data and 20,584 for rights and duties of the patients.
Sample size and losses
Sample size was calculated with data from the pilot study conducted between March and July of 2017. The effect size was determined by the reduction of CHD risk (0.324). Cluster size was of 24, clustering effect of 1.57, control-intervention relationship of 1:1, with an 80% of statistical power and type I error of 5%. A 20% attrition rate was assumed. With this data the calculated sample size was 576, with 288 patients and 11-12 clusters in each study group.
In addition, primary care centers will recruit participants following the proportion of older adults (OA) in the Cardiovascular disease care program (PSCV in spanish) of each one . If a center gathers more than 10% of the total population, that center must recruit 10% of the sample in that group.
Study structure
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
Each participant will sign an informed consent, without knowing that there is another group of patients.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 65 or older.
- •Polypharmacy, defined as five or more chronic prescribed medications.
- •Independent or independent at risk, classified by the chilean scale of autonomy for older adults (EFAM in spanish).
- •Included in the Cardiovascular Primary Care Program.
Exclusion Criteria
- •Low Cardiovascular Disease Risk (CVDR).
- •Participants of the pilot study.
- •Risk of dependency or dependent by the EFAM.
Arms & Interventions
Intervention group
Medication review with follow-up every 2 months, conducted by a trained pharmacist.
Intervention: Medication review with follow-up (Other)
Control group
Usual care by physicians, nurses and dietitians.
Outcomes
Primary Outcomes
Patients with controlled hypertension, type-2 diabetes or dyslipidemia
Time Frame: 12 months
Proportion of patients with controlled diseases by the chilean government treatment goals. Results will be presented for each disease as Odds ratio for achieving goals in control and intervention group.
Incremental Cost-Effectiveness ratio (ICEr)
Time Frame: 12 months
Calculated by the difference in costs between groups, divided by the difference in effects.
Quality of Life (QoL) by visual analog scale (VAS)
Time Frame: 12 months.
Measured by the EuroQol-5D-3L VAS test, where 0 is the worst and 100 is the best possible health status by personal perception.
Quality of Life (QoL) by 5 dimensions.
Time Frame: 12 months
Measured by the EuroQol-5D-3L five dimension test. Each dimension will be presented individually.
Secondary Outcomes
- Fasting glycemia (FG)(12 months)
- Glycated hemoglobin (HbA1c)(12 months)
- Serum electrolytes(12 months)
- Glomerular filtration rate (GFR)(12 months)
- ACR (albumin-creatinine ratio)(12 months)
- Blood pressure (SBP and DBP).(12 months)
- Lipid profile(12 months)
- Costs of the interventions(12 months)
Investigators
Cristián Plaza
Director
Pontificia Universidad Catolica de Chile