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Quality of LifeKOSMOSNCT02238652

Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy

A study testing Communication, Systematic Pain Assessment and Treatment and Medication Review in people with Quality of Life, run by University of Bergen at 32 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Improving quality of life (QoL) in residents of nursing homes: A cluster randomized clinical trial of efficacy - The KOSMOS study. COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Quality of Life
What is being tested?
Communication, Systematic Pain Assessment and Treatment and Medication Review
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
32 sitesNorway
Study dates
Aug 2014to Nov 2015
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Resident in long time care ward in Bergen, Bærum, Sarpsborg, Kvam, Fjell, Sund, Askøy and Øygarden

Who cannot join

  • Dying patients with reduced consciousness at baseline
  • Active Schizophrenia

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Norway32 sites

  • Ask bo og omsorgssenter

    Askøy

  • Solvik

    Baerum, Akershus, 1304

  • Donski Bo og behandlingssenter

    Baerum, Akershus, 1346

  • Mariehaven Bo og behandlingssenter

    Baerum, Akershus, 1346

  • Berger Bo og Behandlingssenter

    Baerum, Akershus, 1349

  • Kolaashjemmet Bo og Behandlingssenter

    Baerum, Akershus, 1352

  • Gullhaug Bo og behandlingssenter

    Baerum, Akershus, 1354

  • Osteraas Bo og behandlingssenter

    Baerum, Akershus, 1361

  • Solbakken Bo og Behandlingssenter

    Baerum, Akershus, 1361

  • Lønnås Bo og Rehabsenter

    Baerum, Akershus, 1362

  • Nordraaksvei bo og behandlingssenter

    Baerum, Akershus, 1369

  • Stabaekktunet Bo og behandlingssenter

    Baerum, Akershus, 1369

  • Stabekk Bo og Behandlingssenter

    Baerum, Akershus, 1369

  • Arna helseheim

    Bergen

  • Frieda Fasmers minne

    Bergen

  • Gullstøltunet Sykehjem

    Bergen

  • Hospitalet Betanien

    Bergen

  • Lyngbøtunet Bo og servicesenter

    Bergen

  • Slettebakken menighets eldresenter

    Bergen

  • University of Bergen

    Bergen

  • Strandebarmheimen

    Kvam

  • Toloheimen

    Kvam

  • Øysteseheimen

    Kvam

  • Tednebakkane omsorgssenter

    Øygarden

  • Borgen sykehjem

    Sarpsborg

  • Eplehagen bofellesskap

    Sarpsborg

  • Haugvoll sykehjem

    Sarpsborg

  • Helsehuset

    Sarpsborg

  • Kurland

    Sarpsborg

  • Tingvoll sykehjem

    Sarpsborg

  • Valaskjold omsorgssenter

    Sarpsborg

  • Sundheimen

    Sund

Other trials in Norway

About this study

Official title: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)

Improving quality of life (QoL) in residents of nursing homes:

A cluster randomized clinical trial of efficacy - The KOSMOS study.

COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.

Read the detailed description

Background: Nursing home (NH) patients have complex mental health problems, disabilities and social needs, compounded by widespread prescription of psychotropic drugs. To preserve their dignity and quality of life is an important goal of our society. This can only be achieved within NHs that offer high competent conditions of treatment and care.

Research questions and hypotheses:

  1. Will the implementation of a communication and end-of-life decision making process have impact on interactions between patients, staff and family? We hypothesize that ACP will improve the interactions between patients, staff and family, and satisfaction in relatives and thereby improve the quality of life NH patients.
  2. Is the KOSMOS capable to affect agitation and aggression and reduce medication e.g. psychotropics in NH patient? We hypothesize that KOSMOS will significantly reduce agitation and aggression, the total amount of medication, and psychotropic drug use.
  3. What combination of interventions will give the broadest benefit, and could be delivered as a routine intervention as part of NH practice? We hypothesize that the comprehensive KOSMOS approach improves QoL and makes positive changes in NH practice.
  4. What other types of advantages are expected? We hypothesize that KOSMOS is a cost-effective approach, with potential to increase the safety and reduce mortality in NH patients.

Method: The KOSMOS intervention combines the most effective research results to improve staff competence, and patients' mental health, safety, QoL, and to reduce psychotropic drug use and costs. The efficacy testing of KOSMOS includes systematic literature review, a pilot study, a 9-month randomized control trial (RCT), and a dissemination plan. Data collection will take place at baseline, months 4, and 9. The intervention entails provision of staff training, study guidelines and manuals. NHs will be randomized to either KOSMOS or current best practice. We will include 38 NH long-term-care (LTC) wards (normally just one ward per NH) in Bergen, Stavanger, Oslo/Bærum, Sarpsborg and Sogn and Fjordane. In total 310 patients ≥65 years will be recruited from these wards

Primary and secondary outcome measures: Quality of life in late stage dementia (QUALID), QUALIDEM, EQ-5-D; Neuropsychiatric Inventory - NH edition (NPI-NH); Activities of Daily Living (ADL); Cornell; Mobilization - Observation - Behaviour - Intensity - Dementia 2 (MOBID-2); drug use; drug-related problems, START; STOP; cost-utility analysis (RUD-FOCA); hospital admission; and mortality, ActiWatch; Log registration of NH activities; Relatives satisfaction with conducted KOSMOS elements

Statistical analyses: include characteristics between 2 groups (Chi square, Mann-Whitney U), ANCOVA, ICC and p-values for each time-point and outcomes.

National and international collaboration: National collaboration between researchers at the Universities of Bergen, Oslo, and Stavanger is established. Internationally, colleagues from the EU COST-Action TD1005, Karolinska University, Stockholm and Kings College, London are engaged in this RCT.

Funding: The employment of two PhD-candidates (100%) and one post-doctoral fellow (50%) received funding by the Norwegian Research Council (Sponsor's Protocol Code: 222113) in 2012.

Conditions
Quality of Life
Being tested
Communication, Systematic Pain Assessment and Treatment, Medication Review, Occupational therapy, Safety
Keywords
Nursing homes, Dementia, Quality of Life, Geriatrics, Aged, Activities of Daily Living, Pain, Pain management, Advance Care Planning, Patient Safety, Costs and Cost Analysis, Medication Errors, Medical Order Entry Systems, Medication Reconciliation, Medication Therapy Management, Depression, Psychotropic Drugs, Informed Consent, Presumed Consent, Anxiety
Medical subject headings
Dementia, Pain, Agnosia, Depression, Anxiety Disorders, Lethargy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CommunicationBehavioural

    Also called advance care planning

    A preparation process before the patient become incapable of participating in life prolonging decisions

  • Systematic Pain Assessment and TreatmentBehavioural

    Also called MOBID-2

    Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.

  • Medication ReviewBehavioural

    An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.

  • Occupational therapyBehavioural

    Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.

  • SafetyBehavioural

    Also called patient safety

    Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.

Study groups in NCT02238652
Study groupRoleWhat they receive
ControlNo interventionNot described
InterventionActive comparatorCommunication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety
Receives: Behavioral: Communication; Behavioral: Systematic Pain Assessment and Treatment; Behavioral: Medication Review; Behavioral: Occupational therapy; Behavioral: Safety

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychiatric symptoms

    Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).

    Measured: 9 months

  2. Quality of life

    Assessing quality of life by Qualidem, QUALID and EQ-5D.

    Measured: 9 months

Secondary outcomes (11)

  1. Activities of daily living

    Assessed by ADL index (range 0-18).

    Measured: 9 months

  2. Mood or depression

    Assessed by Cornell Depression Scale (range 0-38)

    Measured: 9 months

  3. Pain

    Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)

    Measured: 9 months

  4. Medication review

    Use of medication in number of people and dose, especially use of psychotropic drugs

    Measured: 9 months

  5. Drug-related problems

    number of drug-drug-interactions using interactions database, number of drugs prescribed, number of anticholinergics prescribed, number of patients prescribed pain-medication with no pain on the MOBID-2 pain scale, number of patients with anti depressants with a low cornell depression rating scale in dementia.

    Measured: 9 months

  6. Admission to hospital and mortality

    Questionnaire asking nurses wether the patient has been admitted to the hospital at month 4 and month 9.

    Measured: 9 months

  7. Cost-effectiveness

    Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)

    Measured: 9 months

  8. Cost of medication

    Cost-utility analysis will be performed

    Measured: 9 months

  9. Measure of activity

    ActiWatch to register sleep and activity

    Measured: 9 months

  10. Nursing home activity

    Log registration of NH activities

    Measured: 9 months

  11. Relatives satisfaction with conducted KOSMOS elements

    Relatives satisfaction with conducted KOSMOS elements with questionary

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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
Masking
Single blind
Who is masked
Investigator
Enrolment
560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02238652
Sponsor's protocol ID
222113
Acronym
KOSMOS
Status last verified
Sep 2014
First submitted
7 Jul 2014
Last updated
15 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Husebo BS, Flo E, Aarsland D, Selbaek G, Testad I, Gulla C, Aasmul I, Ballard C. COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial. Implement Sci. 2015 Sep 15;10:131. doi: 10.1186/s13012-015-0310-5.

    PubMed 26374231

  • Vislapuu M, Berge LI, Angeles RC, Kjerstad E, Mannseth J, Achterberg WP, Husebo BS. Factors associated with formal and informal resource utilization in nursing home patients with and without dementia: cross-sectional analyses from the COSMOS trial. BMC Health Serv Res. 2022 Nov 2;22(1):1306. doi: 10.1186/s12913-022-08675-y.

    PubMed 36324159

  • Flo-Groeneboom E, Elvegaard T, Gulla C, Husebo BS. The longitudinal association between the use of antihypertensive medications and 24-hour sleep in nursing homes: results from the randomized controlled COSMOS trial. BMC Geriatr. 2021 Jul 18;21(1):430. doi: 10.1186/s12877-021-02317-4.

    PubMed 34275457

  • Gedde MH, Husebo BS, Mannseth J, Kjome RLS, Naik M, Berge LI. Less Is More: The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients. Results From the Cluster-Randomized Controlled COSMOS Trial. Am J Geriatr Psychiatry. 2021 Mar;29(3):304-315. doi: 10.1016/j.jagp.2020.07.004. Epub 2020 Jul 11.

    PubMed 32753339

  • de Jong-Schmit BEM, Poortvliet RKE, Bohringer S, Bogaerts JMK, Achterberg WP, Husebo BS. Blood pressure, antihypertensive medication and neuropsychiatric symptoms in older people with dementia: The COSMOS study. Int J Geriatr Psychiatry. 2021 Jan;36(1):46-53. doi: 10.1002/gps.5388. Epub 2020 Oct 8.

    PubMed 32748494

  • Gulla C, Flo E, Kjome RLS, Husebo BS. Implementing a novel strategy for interprofessional medication review using collegial mentoring and systematic clinical evaluation in nursing homes (COSMOS). BMC Geriatr. 2019 May 7;19(1):130. doi: 10.1186/s12877-019-1139-6.

    PubMed 31064365

  • Habiger TF, Achterberg WP, Flo E, Husebo BS. Psychosis symptoms in nursing home residents with and without dementia-Cross-sectional analyses from the COSMOS study. Int J Geriatr Psychiatry. 2019 May;34(5):683-691. doi: 10.1002/gps.5067. Epub 2019 Mar 4.

    PubMed 30706561

  • Aasmul I, Husebo BS, Sampson EL, Flo E. Advance Care Planning in Nursing Homes - Improving the Communication Among Patient, Family, and Staff: Results From a Cluster Randomized Controlled Trial (COSMOS). Front Psychol. 2018 Dec 4;9:2284. doi: 10.3389/fpsyg.2018.02284. eCollection 2018.

    PubMed 30564163

  • Aasmul I, Husebo BS, Flo E. Description of an advance care planning intervention in nursing homes: outcomes of the process evaluation. BMC Geriatr. 2018 Jan 25;18(1):26. doi: 10.1186/s12877-018-0713-7.

    PubMed 29370766

  • Blytt KM, Bjorvatn B, Husebo B, Flo E. Clinically significant discrepancies between sleep problems assessed by standard clinical tools and actigraphy. BMC Geriatr. 2017 Oct 27;17(1):253. doi: 10.1186/s12877-017-0653-7.

    PubMed 29078755

Questions about this trial

What is this clinical trial studying?

A study testing Communication, Systematic Pain Assessment and Treatment and Medication Review in people with Quality of Life, run by University of Bergen at 32 sites 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 1 inclusion and 2 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites 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?

Neuropsychiatric symptoms (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT02238652, which also lists 10 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 15 Apr 2016.

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