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

Psychotropic Drug Use in the Elderly Living in Nursing Homes - Associations With Clinical Symptoms 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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Anxiety; Cognitive Symptom; Drug Use; Physical Health; Activity of Daily Living; Neuropsychiatric Syndrome
• Intervention / Treatment: Other: Drug reviews with NorGeP-NH

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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Grålum, Norway, 1714
    • Østfold Hospital Trust - Dept. of mental health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of drugs prescribed	Registration with Anatomical Therapeutic Chemical (ATC) code and daily dosage	8 weeks
Number of drugs prescribed	Registration with ATC code and daily dosage	12 weeks
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
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
Depression	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.	8 weeks
Depression	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.	12 weeks
Neuropsychiatric symptoms - agitation	Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	8 weeks
Neuropsychiatric symptoms - agitation	Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	12 weeks
Neuropsychiatric symptoms - affective symptoms	Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	8 weeks
Neuropsychiatric symptoms - affective symptoms	Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms	12 weeks
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
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
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
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
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
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
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
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
Physical health	General Medical Health Rating	Participants will be assessed at baseline, after 8 weeks and 12 weeks
Physical health	Charlson Comorbidity Index	Participants will be assessed at baseline, after 8 weeks and 12 weeks
Physical health	The timed "up and go" test	Participants will be assessed at baseline, after 8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: The Dam Foundation; Sykehuset Innlandet HF; Norwegian Health Association
• Investigators: Principal Investigator: Sverre Bergh, MD, PhD, Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway

Publications and helpful links

General Publications

• 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.
• Nyborg G, Brekke M, Straand J, Gjelstad S, Romoren 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2018
• Primary Completion (ACTUAL): June 7, 2019
• Study Completion (ACTUAL): June 7, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (ACTUAL): November 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations
• Other Study ID Numbers: Drug_review_nursing_homes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, and after approval by the Regional committee for medical and health research ethics, IPD that underlie results in a publication might be shared.
• IPD Sharing Time Frame: Starting 6 months after results publication.
• IPD Sharing Access Criteria: Because of the sensitive nature of the data, any access request will have to be submitted to the Central Contact Person and / or Central Contact Backup. After a preliminary review, the request will be forwarded to Regional committee for medical and health research ethics for approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No