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

NCT03736577 | Completed

• 1 other identifier: Drug_review_nursing_homes
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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. 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. 2.A systematic drug review will decrease the psychotropic drug prescription rates compared to before the drug review.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Number of drugs prescribed

  8 weeks

• Number of drugs prescribed

  12 weeks

• Depression

  8 weeks

• Depression

  12 weeks

• Depression

  8 weeks

Study Arms (2)

NorGeP-NH

EXPERIMENTAL

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

Control nursing home

NO INTERVENTION

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".

Interventions

Drug reviews with NorGeP-NH OTHER

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

NorGeP-NH

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is living in a participating nursing home
• Expected stay for more than 12 weeks

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Sykehuset Innlandet HF: collaborator
• The Dam Foundation: collaborator
• Norwegian Health Association: collaborator

Study Sites (1)

Østfold Hospital Trust - Dept. of mental health

Grålum, 1714, Norway

Location

Related Publications (2)

• 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.

  PMID: 26100966 BACKGROUND

• 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.

  PMID: 28927372 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Neurobehavioral Manifestations; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Sverre Bergh, MD, PhD

  Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: November 12, 2018
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: February 16, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting 6 months after results publication.
• 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.

Locations

NO (1)