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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: Communication; Behavioral: Systematic Pain Assessment and Treatment; Behavioral: Medication Review; Behavioral: Occupational therapy; Behavioral: Safety

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.

• Study Type: Interventional
• Enrollment (Actual): 560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Askøy, Norway
    • Ask bo og omsorgssenter
  • Bergen, Norway
    • Arna helseheim
  • Bergen, Norway
    • Frieda Fasmers minne
  • Bergen, Norway
    • Gullstøltunet Sykehjem
  • Bergen, Norway
    • Hospitalet Betanien
  • Bergen, Norway
    • Lyngbøtunet Bo og servicesenter
  • Bergen, Norway
    • Slettebakken menighets eldresenter
  • Bergen, Norway
    • University of Bergen
  • Kvam, Norway
    • Strandebarmheimen
  • Kvam, Norway
    • Toloheimen
  • Kvam, Norway
    • Øysteseheimen
  • Sarpsborg, Norway
    • Borgen sykehjem
  • Sarpsborg, Norway
    • Eplehagen bofellesskap
  • Sarpsborg, Norway
    • Haugvoll sykehjem
  • Sarpsborg, Norway
    • Helsehuset
  • Sarpsborg, Norway
    • Kurland
  • Sarpsborg, Norway
    • Tingvoll sykehjem
  • Sarpsborg, Norway
    • Valaskjold omsorgssenter
  • Sund, Norway
    • Sundheimen
  • Øygarden, Norway
    • Tednebakkane omsorgssenter
  • Akershus
    • Baerum, Akershus, Norway, 1304
      • Solvik
    • Baerum, Akershus, Norway, 1346
      • Donski Bo og behandlingssenter
    • Baerum, Akershus, Norway, 1346
      • Mariehaven Bo og behandlingssenter
    • Baerum, Akershus, Norway, 1349
      • Berger Bo og Behandlingssenter
    • Baerum, Akershus, Norway, 1352
      • Kolaashjemmet Bo og Behandlingssenter
    • Baerum, Akershus, Norway, 1354
      • Gullhaug Bo og behandlingssenter
    • Baerum, Akershus, Norway, 1361
      • Osteraas Bo og behandlingssenter
    • Baerum, Akershus, Norway, 1361
      • Solbakken Bo og Behandlingssenter
    • Baerum, Akershus, Norway, 1362
      • Lønnås Bo og Rehabsenter
    • Baerum, Akershus, Norway, 1369
      • Nordraaksvei bo og behandlingssenter
    • Baerum, Akershus, Norway, 1369
      • Stabaekktunet Bo og behandlingssenter
    • Baerum, Akershus, Norway, 1369
      • Stabekk Bo og Behandlingssenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Intervention; Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety	Behavioral: Communication; A preparation process before the patient become incapable of participating in life prolonging decisions; Other Names: advance care planning; Behavioral: Systematic Pain Assessment and Treatment; Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.; Other Names: MOBID-2; Behavioral: Medication Review; An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.; Behavioral: Occupational therapy; Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.; Behavioral: 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.; Other Names: patient safety

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatric symptoms	Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).	9 months
Quality of life	Assessing quality of life by Qualidem, QUALID and EQ-5D.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of daily living	Assessed by ADL index (range 0-18).	9 months
Mood or depression	Assessed by Cornell Depression Scale (range 0-38)	9 months
Pain	Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)	9 months
Medication review	Use of medication in number of people and dose, especially use of psychotropic drugs	9 months
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.	9 months
Admission to hospital and mortality	Questionnaire asking nurses wether the patient has been admitted to the hospital at month 4 and month 9.	9 months
Cost-effectiveness	Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)	9 months
Cost of medication	Cost-utility analysis will be performed	9 months
Measure of activity	ActiWatch to register sleep and activity	9 months
Nursing home activity	Log registration of NH activities	9 months
Relatives satisfaction with conducted KOSMOS elements	Relatives satisfaction with conducted KOSMOS elements with questionary	9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation indicators	Assessment of the quality of the implementation on each intervention by monthly visits and phone calls and review of the manuals.	9 months

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: King's College London; University of Oslo; Karolinska Institutet; The Research Council of Norway; Helse Stavanger HF; Rebekka Ege Hegemanns legat
• Investigators: Study Director: Bettina S. Husebø, MD, PhD, University of Bergen; Principal Investigator: Elisabeth Flo, PysD, PhD, University of Bergen; Principal Investigator: Irene Aasmul, Master, University of Bergen; Principal Investigator: Christine Gulla, MD, University of Bergen; Principal Investigator: Torstein Habiger, University of Bergen; Principal Investigator: Tony Elvegaard, University of Bergen

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• de Jong-Schmit BEM, Poortvliet RKE, Böhringer 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Centre for Elderly and Nursing Home Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Pain; Anxiety; Dementia; Pain management; Patient Safety; Costs and Cost Analysis; Mortality; Activities of Daily Living; Medication Therapy Management; Geriatrics; Informed Consent; Aged; Nursing homes; Hospitalization; Psychotropic Drugs; Advance Care Planning; Apathy; Medication Reconciliation; Medication Errors; Medical Order Entry Systems; Presumed Consent
• Other Study ID Numbers: 222113