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Completed

NCT Number: NCT03911934

Polypharmacy Outpatient Clinic

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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Key information

Conditions

Polypharmacy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Outpatient Clinic, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Medication review

Usual Care

Other

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

Other names: Geriatric assessment

Primary outcomes

  1. EQ5D-5L index, 4 months, including death

    Time frame: EQ5D-5L index values at baseline (inclusion) and at 4 months followup

    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.

Secondary outcomes

  1. EQ5D-5L index, 13 months, including death

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

    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.

  2. Mortality

    Time frame: Baseline to 13 months follow-up.

    Comparison of time to death during the 13 month follow-up between the control and intervention group.

  3. Admissions (number)

    Time frame: 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 admissions (any cause)

  4. Admissions (days)

    Time frame: 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 admission days (any cause)

  5. Number of drugs

    Time frame: At 4 month follow-up and 13 month follow-up.

    Number of prescription drugs. Comparison between the control and intervention group.

  6. Falls

    Time frame: Comparison between groups at 4 month follow-up and 13 month follow-up.

    Binary: Any falls the last 3 months?

  7. EQ5D-5L index, 4 months, excluding death

    Time frame: EQ5D-5L index values at baseline (inclusion) and at 4 months followup

    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.

  8. EQ5D-5L index, 13 months, excluding death

    Time frame: EQ5D-5L index values at baseline (inclusion) and at 13 months followup

    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.

  9. EQ5D-5L VAS, 13 months, including death

    Time frame: EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup

    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.

  10. EQ5D-5L VAS, 4 months, including death

    Time frame: EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup

    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.

  11. EQ5D-5L VAS, 13 months, excluding death

    Time frame: EQ5D-5L VAS values at baseline (inclusion) and at 13 months followup

    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.

  12. EQ5D-5L VAS, 4 months, excluding death

    Time frame: EQ5D-5L VAS values at baseline (inclusion) and at 4 months followup

    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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 11, 2019
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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