Pharmacist-led Medication Review With Follow-up on Primary Care Cardiovascular Older Adult Patients.

NCT03502109 | Completed

• 1 other identifier: PUCUTS1
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Medication Adherence; Drug Use; Hypertension; Type 2 Diabetes Mellitus; Dyslipidemias

Keywords

Medication review; Pharmacist; Medication therapy management; Cardiovascular diseases; Economics; Elderly; Primary Care

Outcome Measures

Primary Outcomes (4)

• Patients with controlled hypertension, type-2 diabetes or dyslipidemia

  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.

  12 months

• Quality of Life (QoL) by 5 dimensions.

  Measured by the EuroQol-5D-3L five dimension test. Each dimension will be presented individually.

  12 months

• Incremental Cost-Effectiveness ratio (ICEr)

  Calculated by the difference in costs between groups, divided by the difference in effects.

  12 months

• Quality of Life (QoL) by visual analog scale (VAS)

  Measured by the EuroQol-5D-3L VAS test, where 0 is the worst and 100 is the best possible health status by personal perception.

  12 months.

Secondary Outcomes (8)

• Blood pressure (SBP and DBP).

  12 months

• Fasting glycemia (FG)

  12 months

• Glycated hemoglobin (HbA1c)

  12 months

• Lipid profile

  12 months

• Serum electrolytes

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Medication review with follow-up every 2 months, conducted by a trained pharmacist.

Other: Medication review with follow-up

Control group

NO INTERVENTION

Usual care by physicians, nurses and dietitians.

Interventions

Medication review with follow-up OTHER

Medication review with follow-up: trained pharmacists will conduct consecutive medication reviews by detecting and resolving drug related problems, educational interventions and applying pharmacotherapy changes made in collaboration with physicians.

Also known as: Pharmaceutical care, Pharmacotherapy follow-up

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Low Cardiovascular Disease Risk (CVDR).
• Participants of the pilot study.
• Risk of dependency or dependent by the EFAM.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• University of Technology, Sydney: collaborator

Study Sites (1)

Pontificia Universidad Católica de Chile, Facultad de Química.

Santiago, 7820436, Chile

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Medication Adherence; Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

Medication Review; Pharmaceutical Services

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each participant will sign an informed consent, without knowing that there is another group of patients.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 18, 2018
• Study Start: January 5, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

CL (1)