Clinical trial NCT03911934: Polypharmacy Outpatient Clinic
Official title: Polypharmacy Outpatient Clinic as a Randomized Intervention: Effect on Quality of Life, Admissions and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Keywords: Polypharmacy
Medication review
Randomized
Deprescribing
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 408
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: EQ5D-5L index, 4 months, including death
timeFrame: EQ5D-5L index values at baseline (inclusion) and at 4 months followup
Secondary outcomes:
measure: EQ5D-5L index, 13 months, including death
timeFrame: EQ5D-5L index values at baseline (inclusion) and at 13 months follow-up
measure: Mortality
timeFrame: Baseline to 13 months follow-up.
measure: Admissions (number)
timeFrame: From baseline to 4 month follow-up and from 4 month follow-up to 13 month-followup comparison between the control and intervention group.
measure: Admissions (days)
timeFrame: From baseline to 4 month follow-up and from 4 month follow-up to 13 month-followup comparison between the control and intervention group.
measure: Number of drugs
timeFrame: At 4 month follow-up and 13 month follow-up.
measure: Falls
timeFrame: Comparison between groups at 4 month follow-up and 13 month follow-up.
measure: EQ5D-5L index, 4 months, excluding death
timeFrame: EQ5D-5L index values at baseline (inclusion) and at 4 months followup
measure: EQ5D-5L index, 13 months, excluding death
timeFrame: EQ5D-5L index values at baseline (inclusion) and at 13 months followup
measure: EQ5D-5L VAS, 13 months, including death
timeFrame: EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup
measure: EQ5D-5L VAS, 4 months, including death
timeFrame: EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup
measure: EQ5D-5L VAS, 13 months, excluding death
timeFrame: EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup
measure: EQ5D-5L VAS, 4 months, excluding death
timeFrame: EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Geriatric Outpatient Clinic, Frederiksberg Hospital
Study officials:
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Mikkel B Christensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: