Polypharmacy Outpatient Clinic

NCT03911934 | Completed DMC

• 1 other identifier: Polyamb-01
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy

Keywords

Polypharmacy; Medication review; Randomized; Deprescribing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• EQ5D-5L index, 13 months, including death

  EQ5D-5L index values at baseline (inclusion) and at 13 months follow-up

• Mortality

  Baseline to 13 months follow-up.

• Admissions (number)

  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)

  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

  At 4 month follow-up and 13 month follow-up.

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care in the geriatric outpatient clinic.

Other: Usual care

Usual care plus polypharmacy intervention

EXPERIMENTAL

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: Polypharmacy intervention; Other: Usual care

Interventions

Polypharmacy intervention 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.

Also known as: Medication review

Usual care plus polypharmacy intervention

Usual care OTHER

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

Also known as: Geriatric assessment

Usual care; Usual care plus polypharmacy intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Geriatric Outpatient Clinic, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Kornholt J, Feizi ST, Hansen AS, Laursen JT, Johansson KS, Reuther LO, Petersen TS, Pressel E, Christensen MB. Medication changes implemented during medication reviews and factors related to deprescribing: Posthoc analyses of a randomized clinical trial in geriatric outpatients with polypharmacy. Br J Clin Pharmacol. 2023 Nov;89(11):3291-3301. doi: 10.1111/bcp.15805. Epub 2023 Jul 6.

  PMID: 37254818 DERIVED

MeSH Terms

Interventions

Medication Review; Geriatric Assessment

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Mikkel B Christensen, MD, PhD

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor of the 13 months follow-up EQ5D data is blinded to participant allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, clinical assistent

Model Details: 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).

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: April 11, 2019
• Study Start: June 20, 2017
• Primary Completion: May 12, 2020
• Study Completion: February 8, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)