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Completed

NCT Number: NCT03655405

Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents

This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents

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Key information

Conditions

Polypharmacy Inappropriate Prescribing

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Pharmacie Communautaire

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

Nursing home residents are often prescribed inappropriate medication, drugs whose negative effects outweigh potential benefits or which are not useful anymore. Inappropriate medication have been linked with worse health outcomes, hospitalisations and death. Deprescribing, the structured process of withdrawing or tapering inappropriate medications, has been studied as a potential solution to this problem.

In this study, nursing home residents living in institution which are already engaged in a deprescribing process will be randomly allocated to receive a medication review or usual care. The medication review will be performed by the nursing home pharmacist an its results will be discussed with the responsible physicians and nurses to create a deprescribing plan specifically tailored to the needs of the resident.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Take 5 or more prescribed drugs daily;
  • Reside in the Nursing Home since at least 4 months.

Exclusion criteria

  • Physician judges that discussing deprescribing with them risks destabilising them.

Treatment and study plan

Individual Deprescribing Intervention

Other

The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.

Primary outcomes

  1. Number of Inappropriate Medication at Follow-up

    Time frame: 4 months

    Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.

Secondary outcomes

  1. Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up

    Time frame: 4 months

    Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.

  2. Number of Chronic Drugs Prescribed to Participants

    Time frame: 4 months

    Number of Chronic Drugs Prescribed to Participants

  3. Number of Chronic DDDs Prescribed to Participants

    Time frame: 4 months

    Number of chronic DDDs prescribed to participants

  4. Number of New Drugs Prescribed as a Result of the Intervention

    Time frame: 4 months

    This outcome was not analysed

  5. Health-related Quality of Life

    Time frame: 4 months

    The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes

    • a visual analog scale, ranging from 0 to 100, 100 indicating "the best health you can imagine" and 0 "the worst health you can imagine". Higher results indicate an higher quality of life.
    • 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life.

  6. Number of Common Drug-related Complaints at Follow-up

    Time frame: 4 months

    Number of common drug-related complaints at follow-up

Other outcomes

  1. Number of Deaths

    Time frame: 4 months

    Number of deaths

  2. Number of Participants Hospitalized

    Time frame: 4 months

    Number of participants hospitalized at any time during the study

  3. Days Spent in Hospital

    Time frame: 4 months

    Average number of days spent in hospital during the study period

  4. Number of Falls Per Participant

    Time frame: 4 months

    Average number of falls during the study period

  5. Number of Participants Who Fell

    Time frame: 4 months

    Number of participants who fell at least once during the study period

  6. Number of Falls in Participants That Fell at Least Once

    Time frame: 4 months

  7. Number of Days Spent With Physical Restraints

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Anne Niquille

Other

Registry information

Official study title

Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.

Acronym: OLD-NH-IDeI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
May 19, 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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