Clinical trial NCT02238652: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy
Official title: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
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
Apathy
Hospitalization
Mortality
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Rebekka Ege Hegemanns legat
name: Helse Stavanger HF
name: University of Oslo
name: King's College London
name: Karolinska Institutet
First posted: 2014-09-12
Enrollment: 560
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Dying patients with reduced consciousness at baseline
* Active Schizophrenia

Primary outcomes:
measure: Neuropsychiatric symptoms
timeFrame: 9 months
measure: Quality of life
timeFrame: 9 months
Secondary outcomes:
measure: Activities of daily living
timeFrame: 9 months
measure: Mood or depression
timeFrame: 9 months
measure: Pain
timeFrame: 9 months
measure: Medication review
timeFrame: 9 months
measure: Drug-related problems
timeFrame: 9 months
measure: Admission to hospital and mortality
timeFrame: 9 months
measure: Cost-effectiveness
timeFrame: 9 months
measure: Cost of medication
timeFrame: 9 months
measure: Measure of activity
timeFrame: 9 months
measure: Nursing home activity
timeFrame: 9 months
measure: Relatives satisfaction with conducted KOSMOS elements
timeFrame: 9 months
Other outcomes:
measure: Implementation indicators
timeFrame: 9 months
Locations:
city: Baerum
country: Norway
facility: Solvik
state: Akershus
city: Baerum
country: Norway
facility: Donski Bo og behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Mariehaven Bo og behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Berger Bo og Behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Kolaashjemmet Bo og Behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Gullhaug Bo og behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Osteraas Bo og behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Solbakken Bo og Behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Lønnås Bo og Rehabsenter
state: Akershus
city: Baerum
country: Norway
facility: Nordraaksvei bo og behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Stabaekktunet Bo og behandlingssenter
state: Akershus
city: Baerum
country: Norway
facility: Stabekk Bo og Behandlingssenter
state: Akershus
city: Askøy
country: Norway
facility: Ask bo og omsorgssenter
city: Bergen
country: Norway
facility: Arna helseheim
city: Bergen
country: Norway
facility: Frieda Fasmers minne
city: Bergen
country: Norway
facility: Gullstøltunet Sykehjem
city: Bergen
country: Norway
facility: Hospitalet Betanien
city: Bergen
country: Norway
facility: Lyngbøtunet Bo og servicesenter
city: Bergen
country: Norway
facility: Slettebakken menighets eldresenter
city: Bergen
country: Norway
facility: University of Bergen
city: Kvam
country: Norway
facility: Strandebarmheimen
city: Kvam
country: Norway
facility: Toloheimen
city: Kvam
country: Norway
facility: Øysteseheimen
city: Sarpsborg
country: Norway
facility: Borgen sykehjem
city: Sarpsborg
country: Norway
facility: Eplehagen bofellesskap
city: Sarpsborg
country: Norway
facility: Haugvoll sykehjem
city: Sarpsborg
country: Norway
facility: Helsehuset
city: Sarpsborg
country: Norway
facility: Kurland
city: Sarpsborg
country: Norway
facility: Tingvoll sykehjem
city: Sarpsborg
country: Norway
facility: Valaskjold omsorgssenter
city: Sund
country: Norway
facility: Sundheimen
city: Øygarden
country: Norway
facility: Tednebakkane omsorgssenter
Study officials:
affiliation: University of Bergen
name: Bettina S. Husebø, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Bergen
name: Elisabeth Flo, PysD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bergen
name: Irene Aasmul, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bergen
name: Christine Gulla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bergen
name: Torstein Habiger
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bergen
name: Tony Elvegaard
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.