NCT03911934

Polypharmacy Outpatient Clinic

Polypharmacy Outpatient Clinic as a Randomized Intervention: Effect on Quality of Life, Admissions and Mortality

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Polypharmacy

Interventions

Type	Name	Description
OTHER	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.
OTHER	Usual care	Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician

Timeline

• Start date: 2017-06-20
• Primary completion: 2020-05-12
• Completion: 2021-02-08
• First posted: 2019-04-11
• Last updated: 2021-08-16

Locations

1 site across 1 country: Denmark