Polypharmacy Outpatient Clinic

Bispebjerg Hospital

Status: Completed

Conditions: Polypharmacy

Treatments: Other: Usual care; Other: Polypharmacy intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03911934

Polyamb-01

Details and patient eligibility

About

To investigate the effect of physician-initiated, medication reviews in geriatric patients on self-reported health-related quality of life, admissions, mortality and falls.

Full description

Aim: To investigate the effect of physician-initiated, medication reviews in geriatric patients on self-reported health-related quality of life, admissions and mortality.

Trial design: Randomized trial with polypharmacy intervention in addition to standard geriatric care. After referral to the geriatric outpatient clinic (but before the first visit), a medical secretary screens the patient's medication on the electronic medication list. If the patient is taking more than 8 different drugs, the patient is randomized to either standard geriatric care or standard geriatric care plus polypharmacy intervention. During the first visit, the patient is informed of the project and asked for written, informed consent. If given, we collect data regarding the patient's medication and any medication changes during the intervention, demographics, frailty (FRAIL Scale), Charlson Comorbidity Index, self-reported history of falls, recent admissions, self-reported, health-related quality of life (EQ-5D-5L) and death. Data is collected at baseline, 4 months follow-up and 13 months follow-up.

Participants: All randomized, polymedicated (>8 drugs) patients referred to the geriatric outpatient clinic.

Outcomes: The primary outcome is the between-group difference in the EQ-5D-5L difference (self-reported, health-related quality of life) between baseline and 13 month follow-up.

The secondary outcomes are number of medications, number of successful medication discontinuations, number of admissions and visits to the emergency department, self-reported low-energy falls, and death.

Enrollment: 408 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• New referral to the geriatric outpatient clinic
• More than > 8 different substances in drugs on the electronic medication list before the first visit. Regular and PRN drugs count. Excluding topical treatment (eye drops, ear drops, creams etc) but including inhalation, excluding antibiotics with limited duration, excluding multivitamins, and excluding protein drinks.

Exclusion criteria

• Inability (or refuses) to give informed consent (e.g. because of lack of interest, inability to understand the intervention or language barriers).
• Inability to understand the consent form and/or the intervention.
• Patients referred to the dementia diagnostics unit.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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408 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Usual care in the geriatric outpatient clinic.

Treatment:

Other: Usual care

Usual care plus polypharmacy intervention

Experimental group

Description:

Usual care in the geriatric outpatient clinic plus polypharmacy intervention. Polypharmacy intervention consists of a medication review by a physician from the Department of Clinical Pharmacology plus additional communication with patients' GPs before and after the visit in the outpatient clinic.

Treatment:

Other: Polypharmacy intervention

Other: Usual care