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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736577
• Other study ID #: Drug_review_nursing_homes
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: September 2020
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Activity of Daily Living
• Anxiety
• Cognitive Symptom
• Depression
• Drug Use
• Neurobehavioral Manifestations
• Neuropsychiatric Syndrome
• Physical Health
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Norway	Østfold Hospital Trust - Dept. of mental health	Grålum

Sponsors (4)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Dam Foundation, Norwegian Health Association, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life: QUALID	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	12 weeks
Secondary	Number of drugs prescribed	Registration with Anatomical Therapeutic Chemical (ATC) code and daily dosage	8 weeks
Secondary	Number of drugs prescribed	Registration with ATC code and daily dosage	12 weeks
Secondary	Depression	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.	8 weeks
Secondary	Depression	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.	12 weeks
Secondary	Depression	Montgomery and A°sberg 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.	8 weeks
Secondary	Depression	Montgomery and A°sberg 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.	12 weeks
Secondary	Neuropsychiatric symptoms - agitation	Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	8 weeks
Secondary	Neuropsychiatric symptoms - agitation	Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	12 weeks
Secondary	Neuropsychiatric symptoms - affective symptoms	Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	8 weeks
Secondary	Neuropsychiatric symptoms - affective symptoms	Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	12 weeks
Secondary	Cognition	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.	8 weeks
Secondary	Cognition	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 weeks
Secondary	Cognition	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	8 weeks
Secondary	Cognition	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	12 weeks
Secondary	Anxiety	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.	8 weeks
Secondary	Anxiety	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.	12 weeks
Secondary	Activity of daily living	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.	8 weeks
Secondary	Activity of daily living	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.	12 weeks
Secondary	Physical health	General Medical Health Rating	Participants will be assessed at baseline, after 8 weeks and 12 weeks
Secondary	Physical health	Charlson Comorbidity Index	Participants will be assessed at baseline, after 8 weeks and 12 weeks
Secondary	Physical health	The timed "up and go" test	Participants will be assessed at baseline, after 8 weeks and 12 weeks

External Links

•   Norwegian national guidelines on dementia
•   Report from the Norwegian Institute of Public Health