Clinical trial NCT03736577: Psychotropic Drug Use in the Elderly Living in Nursing Homes and the Influence of a Structured Drug Review
Official title: Psychotropic Drug Use in the Elderly Living in Nursing Homes - Associations With Clinical Symptoms and the Influence of a Structured Drug Review
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Symptom
Depression
Anxiety
Neuropsychiatric Syndrome
Quality of Life
Activity of Daily Living
Physical Health
Drug Use
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
name: The Dam Foundation
name: Norwegian Health Association
First posted: 2018-11-09
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in Quality of Life: QUALID
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of drugs prescribed
timeFrame: 8 weeks
measure: Number of drugs prescribed
timeFrame: 12 weeks
measure: Depression
timeFrame: 8 weeks
measure: Depression
timeFrame: 12 weeks
measure: Depression
timeFrame: 8 weeks
measure: Depression
timeFrame: 12 weeks
measure: Neuropsychiatric symptoms - agitation
timeFrame: 8 weeks
measure: Neuropsychiatric symptoms - agitation
timeFrame: 12 weeks
measure: Neuropsychiatric symptoms - affective symptoms
timeFrame: 8 weeks
measure: Neuropsychiatric symptoms - affective symptoms
timeFrame: 12 weeks
measure: Cognition
timeFrame: 8 weeks
measure: Cognition
timeFrame: 12 weeks
measure: Cognition
timeFrame: 8 weeks
measure: Cognition
timeFrame: 12 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 12 weeks
measure: Activity of daily living
timeFrame: 8 weeks
measure: Activity of daily living
timeFrame: 12 weeks
measure: Physical health
timeFrame: Participants will be assessed at baseline, after 8 weeks and 12 weeks
measure: Physical health
timeFrame: Participants will be assessed at baseline, after 8 weeks and 12 weeks
measure: Physical health
timeFrame: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Grålum
country: Norway
facility: Østfold Hospital Trust - Dept. of mental health
Study officials:
affiliation: Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway
name: Sverre Bergh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.