Polypharmacy Outpatient Clinic

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

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

Study Overview

• Status: Completed
• Conditions: Polypharmacy
• Intervention / Treatment: Other: Usual care; Other: Polypharmacy intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • Geriatric Outpatient Clinic, Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual care; Usual care in the geriatric outpatient clinic.	Other: Usual care; Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician; Other Names: Geriatric assessment
EXPERIMENTAL: 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.	Other: Usual care; Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician; Other Names: Geriatric assessment; 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 Names: Medication review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-5L index, 4 months, including death	Comparison of changes in EQ5D-5L index from baseline to 4 months follow-up between the control and intervention group (including death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents consitute a health state that is translated into an index value using the Danish EQ-5D-5L Value Set from 2021 (see Jensen et al. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Appl Health Econ Health Policy. 2021 Feb 2. doi: 10.1007/s40258-021-00639-3. PMID: 33527304). The index value is anchored at 0 = death and 1 = full health and the range in the Danish population ranges from -0.758 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.	EQ5D-5L index values at baseline (inclusion) and at 4 months followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-5L index, 13 months, including death	Comparison of changes in EQ5D-5L index from baseline to 13 months follow-up between the control and intervention group (including death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents consitute a health state that is translated into an index value using the Danish EQ-5D-5L Value Set from 2021 (see Jensen et al. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Appl Health Econ Health Policy. 2021 Feb 2. doi: 10.1007/s40258-021-00639-3. PMID: 33527304). The index value is anchored at 0 = death and 1 = full health and the range in the Danish population ranges from -0.758 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.	EQ5D-5L index values at baseline (inclusion) and at 13 months follow-up
Mortality	Comparison of time to death during the 13 month follow-up between the control and intervention group.	Baseline to 13 months follow-up.
Admissions (number)	Number of admissions (any cause)	From baseline to 4 month follow-up and from 4 month follow-up to 13 month-followup comparison between the control and intervention group.
Admissions (days)	Number of admission days (any cause)	From baseline to 4 month follow-up and from 4 month follow-up to 13 month-followup comparison between the control and intervention group.
Number of drugs	Number of prescription drugs. Comparison between the control and intervention group.	At 4 month follow-up and 13 month follow-up.
Falls	Binary: Any falls the last 3 months?	Comparison between groups at 4 month follow-up and 13 month follow-up.
EQ5D-5L index, 4 months, excluding death	Comparison of changes in EQ5D-5L index from baseline to 4 months follow-up between the control and intervention group (excluding death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents consitute a health state that is translated into an index value using the Danish EQ-5D-5L Value Set from 2021 (see Jensen et al. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Appl Health Econ Health Policy. 2021 Feb 2. doi: 10.1007/s40258-021-00639-3. PMID: 33527304). The index value is anchored at 0 = death and 1 = full health and the range in the Danish population ranges from -0.758 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.	EQ5D-5L index values at baseline (inclusion) and at 4 months followup
EQ5D-5L index, 13 months, excluding death	Comparison of changes in EQ5D-5L index from baseline to 13 months follow-up between the control and intervention group (excluding death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents consitute a health state that is translated into an index value using the Danish EQ-5D-5L Value Set from 2021 (see Jensen et al. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Appl Health Econ Health Policy. 2021 Feb 2. doi: 10.1007/s40258-021-00639-3. PMID: 33527304). The index value is anchored at 0 = death and 1 = full health and the range in the Danish population ranges from -0.758 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.	EQ5D-5L index values at baseline (inclusion) and at 13 months followup
EQ5D-5L VAS, 13 months, including death	Comparison of changes in EQ5D-5L VAS from baseline to 13 months follow-up between the control and intervention group (including death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The visual analog scale's (VAS) range is from 0 (worst health imaginable) to 100 (best health imaginable) and the participants score their own health. Higher values / increases in EQ-5D VAS is better compared with lower values / decreases in EQ-5D VAS.	EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup
EQ5D-5L VAS, 4 months, including death	Comparison of changes in EQ5D-5L VAS from baseline to 4 months follow-up between the control and intervention group (including death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The visual analog scale's (VAS) range is from 0 (worst health imaginable) to 100 (best health imaginable) and the participants score their own health. Higher values / increases in EQ-5D VAS is better compared with lower values / decreases in EQ-5D VAS.	EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup
EQ5D-5L VAS, 13 months, excluding death	Comparison of changes in EQ5D-5L VAS from baseline to 13 months follow-up between the control and intervention group (excluding death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The visual analog scale's (VAS) range is from 0 (worst health imaginable) to 100 (best health imaginable) and the participants score their own health. Higher values / increases in EQ-5D VAS is better compared with lower values / decreases in EQ-5D VAS.	EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup
EQ5D-5L VAS, 4 months, excluding death	Comparison of changes in EQ5D-5L VAS from baseline to 4 months follow-up between the control and intervention group (excluding death). EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The visual analog scale's (VAS) range is from 0 (worst health imaginable) to 100 (best health imaginable) and the participants score their own health. Higher values / increases in EQ-5D VAS is better compared with lower values / decreases in EQ-5D VAS.	EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Mikkel B Christensen, MD, PhD, University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2017
• Primary Completion (ACTUAL): May 12, 2020
• Study Completion (ACTUAL): February 8, 2021

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (ACTUAL): April 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Polypharmacy; Randomized; Deprescribing; Medication review
• Other Study ID Numbers: Polyamb-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No