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

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ClinicalTrials.gov Identifier: NCT03736577
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Ostfold Hospital Trust

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cognitive Symptom Depression Anxiety Neuropsychiatric Syndrome Quality of Life Activity of Daily Living Physical Health Drug Use Other: Drug reviews with NorGeP-NH Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-armed cluster randomized trial. As the intervention is to introduce a new way to do drug chart reviews, to prevent contamination bias within the nursing home the whole nursing home will have to be treated as a cluster. The recruited nursing homes will be randomized by a statistician to either intervention or control. Before randomization, both physicians working in the recruited facilities and selected personnel, i.e. specialized nurses, will attend a three hours lecture on dementia, depression and anxiety and psychosis on the elderly.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychotropic Drug Use in the Elderly Living in Nursing Homes - Associations With Clinical Symptoms and the Influence of a Structured Drug Review
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NorGeP-NH

Initially, a three hours lecture on dementia, depression, anxiety and psychosis on the elderly will be held. Both physicians working in the facilities and selected personnel, i.e. specialized nurses, will attend.

Intervention: Drug reviews with NorGeP-NH 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) and they will do a structured drug review on the participants` drug charts.

Other: Drug reviews with NorGeP-NH
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

No Intervention: Control nursing home
Initially, a three hours lecture on dementia, depression, anxiety and psychosis on the elderly will be held. Both physicians working in the facilities and selected personnel, i.e. specialized nurses, will attend. Physicians will not attend any lecture about drug reviews and they will keep treating participants "as usual".



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736577


Contacts
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Contact: Enrico Callegari, MD +4746782717 enrcal@so-hf.no
Contact: Sverre Bergh, MD, PhD +4745679393 Sverre.Bergh@sykehuset-innlandet.no

Locations
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Norway
Østfold Hospital Trust - Dept. of mental health Recruiting
Grålum, Norway, 1714
Contact: Enrico Callegari, MD    +4746782717    enrcal@so-hf.no   
Contact: Hege Karine Jacobsen    +4769860000    Hege.Karine.Jacobsen@so-hf.no   
Sponsors and Collaborators
Ostfold Hospital Trust
Sykehuset Innlandet HF
Investigators
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Principal Investigator: Sverre Bergh, MD, PhD Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway

Additional Information:
Publications:
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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03736577     History of Changes
Other Study ID Numbers: Drug_review_nursing_homes
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It has to be discussed in detail

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychotropic Drugs