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Completed

NCT Number: NCT03736577

Psychotropic Drug Use in the Elderly Living in Nursing Homes and the Influence of a Structured Drug Review

The overall aim of this study is to explore if a structured drug review will change clinical symptoms and the psychotropic drugs prescription rate in the elderly living in nursing homes (participants of the study). The study will examine how training of nursing home physicians on reviewing prescription lists using the Norwegian general practice criteria - Nursing homes (NorGeP-NH) will influence the participants' clinical symptoms such as cognition, depression, anxiety and their quality of life. Secondary, we will analyse how a structured drug review will influence further psychotropic drug prescribing rates in nursing homes.

The hypothesis for this study are:

1. Training of nursing home physicians on doing a systematic drug review will decrease the participants' clinical symptoms and improve their Quality of Life. 2. A systematic drug review will decrease the psychotropic drug prescription rates compared to before the drug review.

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Key information

Conditions

Cognitive Symptom Activity of Daily Living Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Drug Use Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuropsychiatric Syndrome Pathological Conditions, Signs and Symptoms Physical Health Quality of Life Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust - Dept. of mental health

Grålum, 1714, Norway

About this study

Norwegian national guidelines recommend a very cautious use of psychotropic drugs in the elderly, especially for treating dementia-related symptoms. These drugs should be used at a very low dosage and for as short a time as possible. Despite these strict guidelines, patients with and without dementia living in nursing homes still receive a high amount of psychotropic drugs. Thus, there should be a higher focus on lowering the use of psychotropic medications in nursing homes. A reduction of prescription of potential harmful and inappropriate drugs for the elderly may improve the clinical symptoms of the patients, reduce the interaction between drugs and the side-effects, and thereby improving the quality of life of the patients.

In 2018 the Norwegian Institute of Public Health updated a report about the general health in the Norwegian elderly population. This report shows that prescription rates for the majority of drugs in the population above 65 years of age have increased in the past 11 years. Unfortunately, Norway does not have a prescription registry for patients living in nursing homes and according to the same report the drug use and the increase of prescription rates in nursing homes is underestimated. During the last years Norwegian authorities, media and user organizations have shown a particular interest in this subject, showing how clinical practice still differs from national and international guidelines, and focusing on the severity of polypharmacy in the elderly living in institutions, particularly concerning patients with dementia receiving psychotropic drugs.

As a result of missing data concerning the real use and increase of drug prescriptions in nursing homes, our study will keep exploring the psychotropic drug use in the elderly population living in Norwegian nursing homes, and it will increase the knowledge about risk factors associated to higher prescription rates. The effect of structured reviews with NorGeP is understudied, and the proposed randomized controlled trial could therefore add valuable knowledge to the field, by exploring how specific training for health personnel working in nursing homes will affect drug prescription in the future.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The participant is living in a participating nursing home
  • Expected stay for more than 12 weeks

Exclusion criteria

  • Severe somatic or psychiatric disease where the participant is too debilitated or not able to cooperate, or where the examination or assessment would cause a too big psychological and physical burden (i.e. severe psychotic state)

Treatment and study plan

Drug reviews with NorGeP-NH

Other

Physicians in the intervention group will attend a 1-2 hours lecture about psychopharmacology and drug review. They will learn how to do drug reviews with the Norwegian general practice criteria - Nursing homes (NorGeP-NH). The nursing home physicians will do the drug review on the participants' drug charts

Primary outcomes

  1. Change in Quality of Life: QUALID

    Time frame: 12 weeks

    Quality of Life in Late-Stage Dementia (QUALID) - Reporting the QoL of the patients on a scale from 11-55 where lower score indicates better QoL

Secondary outcomes

  1. Number of drugs prescribed

    Time frame: 8 weeks

    Registration with Anatomical Therapeutic Chemical (ATC) code and daily dosage

  2. Number of drugs prescribed

    Time frame: 12 weeks

    Registration with ATC code and daily dosage

  3. Depression

    Time frame: 8 weeks

    Cornell Scale for depression in dementia (CDSS). Score range 0-38. A score totaling six (6) or less indicates no depression. A score totaling between seven (7) and eleven (11) indicates possible depression. A score totaling twelve (12) or more indicates major depression.

  4. Depression

    Time frame: 12 weeks

    Cornell Scale for depression in dementia (CDSS). Score range 0-38. A score totaling six (6) or less indicates no depression. A score totaling between seven (7) and eleven (11) indicates possible depression. A score totaling twelve (12) or more indicates major depression.

  5. Depression

    Time frame: 8 weeks

    Montgomery and Åsberg Depression Rating Scale (MADRS). Score range 0-60. A score totaling six (6) or less indicate no depression. A score totaling between seven (7) and nineteen (19) indicates mild depression. A score totaling between twenty (20) and thirty-four (34) indicates moderate depression. A score totaling thirty-five (35) or more indicates severe depression.

  6. Depression

    Time frame: 12 weeks

    Montgomery and Åsberg Depression Rating Scale (MADRS). Score range 0-60. A score totaling six (6) or less indicate no depression. A score totaling between seven (7) and nineteen (19) indicates mild depression. A score totaling between twenty (20) and thirty-four (34) indicates moderate depression. A score totaling thirty-five (35) or more indicates severe depression.

  7. Neuropsychiatric symptoms - agitation

    Time frame: 8 weeks

    Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms

  8. Neuropsychiatric symptoms - agitation

    Time frame: 12 weeks

    Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms

  9. Neuropsychiatric symptoms - affective symptoms

    Time frame: 8 weeks

    Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms

  10. Neuropsychiatric symptoms - affective symptoms

    Time frame: 12 weeks

    Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms

  11. Cognition

    Time frame: 8 weeks

    Montreal Cognitive Assessment. Score range 0-30. A score totaling twenty-six (26) or more indicates no cognitive impairment. A score totaling twenty-five (25) or less indicates cognitive impairment.

  12. Cognition

    Time frame: 12 weeks

    Montreal Cognitive Assessment. Score range 0-30. A score totaling twenty-six (26) or more indicates no cognitive impairment. A score totaling twenty-five (25) or less indicates cognitive impairment.

  13. Cognition

    Time frame: 8 weeks

    Clinical Dementia Rating Scale. The total score is calculated through a particular scoring algorithm. The final score can result in the following values: 0 = normal; 0,5 = very mild dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia

  14. Cognition

    Time frame: 12 weeks

    Clinical Dementia Rating Scale. The total score is calculated through a particular scoring algorithm. The final score can result in the following values: 0 = normal; 0,5 = very mild dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia

  15. Anxiety

    Time frame: 8 weeks

    Geriatric Anxiety Inventory - a 20-items instrument to evaluate the severity of anxiety. Score range 0 - 20. A higher score indicates a higher severity of anxiety.

  16. Anxiety

    Time frame: 12 weeks

    Geriatric Anxiety Inventory - a 20-items instrument to evaluate the severity of anxiety. Score range 0 - 20. A higher score indicates a higher severity of anxiety.

  17. Activity of daily living

    Time frame: 8 weeks

    Physical Self-Maintenance Scale. A 6-items instrument to describe a person's highest level of functioning. Each item can be scored from 1 to 5. A lower score indicates better functioning.

  18. Activity of daily living

    Time frame: 12 weeks

    Physical Self-Maintenance Scale. A 6-items instrument to describe a person's highest level of functioning. Each item can be scored from 1 to 5. A lower score indicates better functioning.

  19. Physical health

    Time frame: Participants will be assessed at baseline, after 8 weeks and 12 weeks

    General Medical Health Rating

  20. Physical health

    Time frame: Participants will be assessed at baseline, after 8 weeks and 12 weeks

    Charlson Comorbidity Index

  21. Physical health

    Time frame: Participants will be assessed at baseline, after 8 weeks and 12 weeks

    The timed "up and go" test

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Norwegian Health Association
  • Sykehuset Innlandet HF
  • The Dam Foundation

Registry information

Official study title

Psychotropic Drug Use in the Elderly Living in Nursing Homes - Associations With Clinical Symptoms and the Influence of a Structured Drug Review

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2018
Registry last updated
Feb 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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