Cognitive SymptomNCT03736577
Psychotropic Drug Use in the Elderly Living in Nursing Homes and the Influence of a Structured Drug Review
A study testing Drug reviews with NorGeP-NH in people with Cognitive Symptom and Depression, run by Ostfold Hospital Trust at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Symptom, Depression, Anxiety
- What is being tested?
- Drug reviews with NorGeP-NH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteNorway
- Study dates
- 12 Nov 2018to 7 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The participant is living in a participating nursing home
- Expected stay for more than 12 weeks
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Training of nursing home physicians on doing a systematic drug review will decrease the participants' clinical symptoms and improve their Quality of Life.
- A systematic drug review will decrease the psychotropic drug prescription rates compared to before the drug review.
Read the 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.
- Conditions
- Cognitive Symptom, Depression, Anxiety, Neuropsychiatric Syndrome, Quality of Life, Activity of Daily Living
- Being tested
- Drug reviews with NorGeP-NH
- Medical subject headings
- Neurobehavioral Manifestations, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug reviews with NorGeP-NHOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (21)
Number of drugs prescribed
Registration with Anatomical Therapeutic Chemical (ATC) code and daily dosage
Measured: 8 weeks
Number of drugs prescribed
Registration with ATC code and daily dosage
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Neuropsychiatric symptoms - agitation
Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
Measured: 8 weeks
Neuropsychiatric symptoms - agitation
Neuropsychiatric Inventory - agitation subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
Measured: 12 weeks
Neuropsychiatric symptoms - affective symptoms
Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
Measured: 8 weeks
Neuropsychiatric symptoms - affective symptoms
Neuropsychiatric Inventory - affective subsyndrome. Instrument used to evaluate the presence and severity of neuropsychiatric symptoms
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Physical health
General Medical Health Rating
Measured: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Physical health
Charlson Comorbidity Index
Measured: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Physical health
The timed "up and go" test
Measured: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start12 Nov 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, The Dam Foundation, Norwegian Health Association
- Responsible party
- Sponsor
- Investigators
- Sverre Bergh, MD, PhD, Principal investigator, Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736577
- Sponsor's protocol ID
- Drug_review_nursing_homes
- Status last verified
- Sep 2020
- First submitted
- 6 Nov 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 26100966Nyborg 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.
PubMed 28927372
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotropic Drug Use in the Elderly Living in Nursing Homes - Associations With Clinical Symptoms and the Influence of a Structured Drug Review
- ClinicalTrials.gov ID
- NCT03736577
- Acronym / sponsor ID
- Drug_review_nursing_homes
- Conditions
- Cognitive Symptom, Depression, Anxiety, Neuropsychiatric Syndrome, Quality of Life, Activity of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, The Dam Foundation, Norwegian Health Association
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Training of nursing home physicians on doing a systematic drug review will decrease the participants' clinical symptoms and improve their Quality of Life.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NorGeP-NH | Experimental | Other: Drug reviews with NorGeP-NHInitially, 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. |
| 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". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The participant is living in a participating nursing home
- Expected stay for more than 12 weeks
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug reviews with NorGeP-NHPhysicians 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 | Other | NorGeP-NH |
Primary outcome
Change in Quality of Life: QUALID
Time frame: 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
21 secondary outcomes
Number of drugs prescribed
Time frame: 8 weeks
Number of drugs prescribed
Time frame: 12 weeks
Depression
Time frame: 8 weeks
Depression
Time frame: 12 weeks
Depression
Time frame: 8 weeks
Depression
Time frame: 12 weeks
Neuropsychiatric symptoms - agitation
Time frame: 8 weeks
Neuropsychiatric symptoms - agitation
Time frame: 12 weeks
Neuropsychiatric symptoms - affective symptoms
Time frame: 8 weeks
Neuropsychiatric symptoms - affective symptoms
Time frame: 12 weeks
Cognition
Time frame: 8 weeks
Cognition
Time frame: 12 weeks
Cognition
Time frame: 8 weeks
Cognition
Time frame: 12 weeks
Anxiety
Time frame: 8 weeks
Anxiety
Time frame: 12 weeks
Activity of daily living
Time frame: 8 weeks
Activity of daily living
Time frame: 12 weeks
Physical health
Time frame: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Physical health
Time frame: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Physical health
Time frame: Participants will be assessed at baseline, after 8 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 26100966Nyborg 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.
- Background: PubMed 28927372Nyborg 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.
- Report from the Norwegian Institute of Public HealthLink provided by the sponsor.
- Norwegian national guidelines on dementiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sverre Bergh, MD, PhD principal investigator
Innlandet Hospital Trust, Postboks 104, 2381 Brumunddal, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug reviews with NorGeP-NH in people with Cognitive Symptom and Depression, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life: QUALID (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736577, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.