Polypharmacy Outpatient Clinic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2021-02-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Polypharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel clinical trial with two arms. The participants are randomized to usual care or usual care plus polypharmacy intervention when they are referred to the geriatric outpatient clinic before the first visit. They stay in the assigned group until end of trial (after 13 months follow-up). Randomization is performed by the medical secretaries in the outpatient clinic in REDCap's randomization module and randomization is stratified on gender, age group (65-70 years, 71-80 years, \>80 years) and number of drugs (9-11 drugs, 12-16 drugs, \>16 drugs).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor of the 13 months follow-up EQ5D data is blinded to participant allocation.

Study Groups

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Usual care

Usual care in the geriatric outpatient clinic.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician

Usual care plus polypharmacy intervention

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.

Group Type EXPERIMENTAL

Polypharmacy intervention

Intervention Type OTHER

A physician from the Department of Clinical Pharmacology prepares a critial medication review before the first visit in the outpatient clinic through critical review of the patient's medical journal and communication with the patient's GP. During the visit in the outpatient clinic, medications are changed based on the medication review with consent from the patient. After the visit the GP is notified of the changes. It is possible to see the patient more than one time in the outpatient clinic (might be needed if tapering or lots of changes) and possible to follow-up on medication changes by telephone with the patient.

Usual care

Intervention Type OTHER

Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician

Interventions

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Polypharmacy intervention

A physician from the Department of Clinical Pharmacology prepares a critial medication review before the first visit in the outpatient clinic through critical review of the patient's medical journal and communication with the patient's GP. During the visit in the outpatient clinic, medications are changed based on the medication review with consent from the patient. After the visit the GP is notified of the changes. It is possible to see the patient more than one time in the outpatient clinic (might be needed if tapering or lots of changes) and possible to follow-up on medication changes by telephone with the patient.

Intervention Type OTHER

Usual care

Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician

Intervention Type OTHER

Other Intervention Names

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Medication review Geriatric assessment

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No