Psychotropic Drug Use in the Elderly Living in Nursing Homes and the Influence of a Structured Drug Review
Study Details
Study Description
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:
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Training of nursing home physicians on doing a systematic drug review will decrease the participants' clinical symptoms and improve their Quality of Life.
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A systematic drug review will decrease the psychotropic drug prescription rates compared to before the drug review.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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". |
Outcome Measures
Primary Outcome Measures
- Change in Quality of Life: QUALID [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
- Number of drugs prescribed [8 weeks]
Registration with Anatomical Therapeutic Chemical (ATC) code and daily dosage
- Number of drugs prescribed [12 weeks]
Registration with ATC code and daily dosage
- Depression [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.
- Depression [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.
- Depression [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.
- Depression [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.
- Neuropsychiatric symptoms - agitation [8 weeks]
Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
- Neuropsychiatric symptoms - agitation [12 weeks]
Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
- Neuropsychiatric symptoms - affective symptoms [8 weeks]
Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
- Neuropsychiatric symptoms - affective symptoms [12 weeks]
Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
- Cognition [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.
- Cognition [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.
- Cognition [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
- Cognition [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
- Anxiety [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.
- Anxiety [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.
- Activity of daily living [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.
- Activity of daily living [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.
- Physical health [Participants will be assessed at baseline, after 8 weeks and 12 weeks]
General Medical Health Rating
- Physical health [Participants will be assessed at baseline, after 8 weeks and 12 weeks]
Charlson Comorbidity Index
- Physical health [Participants will be assessed at baseline, after 8 weeks and 12 weeks]
The timed "up and go" test
Eligibility Criteria
Criteria
Inclusion Criteria:
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The participant is living in a participating nursing home
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Østfold Hospital Trust - Dept. of mental health | Grålum | Norway | 1714 |
Sponsors and Collaborators
- Ostfold Hospital Trust
- Sykehuset Innlandet HF
- The Dam Foundation
- Norwegian Health Association
Investigators
- Principal Investigator: Sverre Bergh, MD, PhD, Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Nyborg G, Brekke M, Straand J, Gjelstad S, Romøren M. Potentially inappropriate medication use in nursing homes: an observational study using the NORGEP-NH criteria. BMC Geriatr. 2017 Sep 19;17(1):220. doi: 10.1186/s12877-017-0608-z.
- Nyborg G, Straand J, Klovning A, Brekke M. The Norwegian General Practice--Nursing Home criteria (NORGEP-NH) for potentially inappropriate medication use: A web-based Delphi study. Scand J Prim Health Care. 2015 Jun;33(2):134-41. doi: 10.3109/02813432.2015.1041833. Epub 2015 Jun 23.
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