<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02238652</url>
  </required_header>
  <id_info>
    <org_study_id>222113</org_study_id>
    <nct_id>NCT02238652</nct_id>
  </id_info>
  <brief_title>Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy</brief_title>
  <acronym>KOSMOS</acronym>
  <official_title>Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rebekka Ege Hegemanns legat</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bergen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improving quality of life (QoL) in residents of nursing homes:&#xD;
&#xD;
      A cluster randomized clinical trial of efficacy - The KOSMOS study.&#xD;
&#xD;
      COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and&#xD;
      treatment, Medication review, Occupational therapy, and Safety) is a practical intervention&#xD;
      aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention&#xD;
      combines the most effective research results to improve staff competence and patients' mental&#xD;
      health, safety, QoL. We also aim to reduce psychotropic drug use and costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Nursing home (NH) patients have complex mental health problems, disabilities and&#xD;
      social needs, compounded by widespread prescription of psychotropic drugs. To preserve their&#xD;
      dignity and quality of life is an important goal of our society. This can only be achieved&#xD;
      within NHs that offer high competent conditions of treatment and care.&#xD;
&#xD;
      Research questions and hypotheses:&#xD;
&#xD;
        1. Will the implementation of a communication and end-of-life decision making process have&#xD;
           impact on interactions between patients, staff and family? We hypothesize that ACP will&#xD;
           improve the interactions between patients, staff and family, and satisfaction in&#xD;
           relatives and thereby improve the quality of life NH patients.&#xD;
&#xD;
        2. Is the KOSMOS capable to affect agitation and aggression and reduce medication e.g.&#xD;
           psychotropics in NH patient? We hypothesize that KOSMOS will significantly reduce&#xD;
           agitation and aggression, the total amount of medication, and psychotropic drug use.&#xD;
&#xD;
        3. What combination of interventions will give the broadest benefit, and could be delivered&#xD;
           as a routine intervention as part of NH practice? We hypothesize that the comprehensive&#xD;
           KOSMOS approach improves QoL and makes positive changes in NH practice.&#xD;
&#xD;
        4. What other types of advantages are expected? We hypothesize that KOSMOS is a&#xD;
           cost-effective approach, with potential to increase the safety and reduce mortality in&#xD;
           NH patients.&#xD;
&#xD;
      Method: The KOSMOS intervention combines the most effective research results to improve staff&#xD;
      competence, and patients' mental health, safety, QoL, and to reduce psychotropic drug use and&#xD;
      costs. The efficacy testing of KOSMOS includes systematic literature review, a pilot study, a&#xD;
      9-month randomized control trial (RCT), and a dissemination plan. Data collection will take&#xD;
      place at baseline, months 4, and 9. The intervention entails provision of staff training,&#xD;
      study guidelines and manuals. NHs will be randomized to either KOSMOS or current best&#xD;
      practice. We will include 38 NH long-term-care (LTC) wards (normally just one ward per NH) in&#xD;
      Bergen, Stavanger, Oslo/Bærum, Sarpsborg and Sogn and Fjordane. In total 310 patients ≥65&#xD;
      years will be recruited from these wards&#xD;
&#xD;
      Primary and secondary outcome measures: Quality of life in late stage dementia (QUALID),&#xD;
      QUALIDEM, EQ-5-D; Neuropsychiatric Inventory - NH edition (NPI-NH); Activities of Daily&#xD;
      Living (ADL); Cornell; Mobilization - Observation - Behaviour - Intensity - Dementia 2&#xD;
      (MOBID-2); drug use; drug-related problems, START; STOP; cost-utility analysis (RUD-FOCA);&#xD;
      hospital admission; and mortality, ActiWatch; Log registration of NH activities; Relatives&#xD;
      satisfaction with conducted KOSMOS elements&#xD;
&#xD;
      Statistical analyses: include characteristics between 2 groups (Chi square, Mann-Whitney U),&#xD;
      ANCOVA, ICC and p-values for each time-point and outcomes.&#xD;
&#xD;
      National and international collaboration: National collaboration between researchers at the&#xD;
      Universities of Bergen, Oslo, and Stavanger is established. Internationally, colleagues from&#xD;
      the EU COST-Action TD1005, Karolinska University, Stockholm and Kings College, London are&#xD;
      engaged in this RCT.&#xD;
&#xD;
      Funding: The employment of two PhD-candidates (100%) and one post-doctoral fellow (50%)&#xD;
      received funding by the Norwegian Research Council (Sponsor's Protocol Code: 222113) in 2012.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychiatric symptoms</measure>
    <time_frame>9 months</time_frame>
    <description>Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>9 months</time_frame>
    <description>Assessing quality of life by Qualidem, QUALID and EQ-5D.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living</measure>
    <time_frame>9 months</time_frame>
    <description>Assessed by ADL index (range 0-18).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood or depression</measure>
    <time_frame>9 months</time_frame>
    <description>Assessed by Cornell Depression Scale (range 0-38)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>9 months</time_frame>
    <description>Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication review</measure>
    <time_frame>9 months</time_frame>
    <description>Use of medication in number of people and dose, especially use of psychotropic drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug-related problems</measure>
    <time_frame>9 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to hospital and mortality</measure>
    <time_frame>9 months</time_frame>
    <description>Questionnaire asking nurses wether the patient has been admitted to the hospital at month 4 and month 9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>9 months</time_frame>
    <description>Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of medication</measure>
    <time_frame>9 months</time_frame>
    <description>Cost-utility analysis will be performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of activity</measure>
    <time_frame>9 months</time_frame>
    <description>ActiWatch to register sleep and activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nursing home activity</measure>
    <time_frame>9 months</time_frame>
    <description>Log registration of NH activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relatives satisfaction with conducted KOSMOS elements</measure>
    <time_frame>9 months</time_frame>
    <description>Relatives satisfaction with conducted KOSMOS elements with questionary</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Implementation indicators</measure>
    <time_frame>9 months</time_frame>
    <description>Assessment of the quality of the implementation on each intervention by monthly visits and phone calls and review of the manuals.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">560</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Communication</intervention_name>
    <description>A preparation process before the patient become incapable of participating in life prolonging decisions</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>advance care planning</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Systematic Pain Assessment and Treatment</intervention_name>
    <description>Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>MOBID-2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medication Review</intervention_name>
    <description>An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Occupational therapy</intervention_name>
    <description>Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safety</intervention_name>
    <description>Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>patient safety</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident in long time care ward in Bergen, Bærum, Sarpsborg, Kvam, Fjell, Sund, Askøy&#xD;
             and Øygarden&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dying patients with reduced consciousness at baseline&#xD;
&#xD;
          -  Active Schizophrenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bettina S. Husebø, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elisabeth Flo, PysD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Irene Aasmul, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christine Gulla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Torstein Habiger</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tony Elvegaard</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Solvik</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1304</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donski Bo og behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1346</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mariehaven Bo og behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1346</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berger Bo og Behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1349</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolaashjemmet Bo og Behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1352</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gullhaug Bo og behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1354</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osteraas Bo og behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1361</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solbakken Bo og Behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1361</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lønnås Bo og Rehabsenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1362</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordraaksvei bo og behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1369</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stabaekktunet Bo og behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1369</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stabekk Bo og Behandlingssenter</name>
      <address>
        <city>Baerum</city>
        <state>Akershus</state>
        <zip>1369</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ask bo og omsorgssenter</name>
      <address>
        <city>Askøy</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arna helseheim</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frieda Fasmers minne</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gullstøltunet Sykehjem</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospitalet Betanien</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyngbøtunet Bo og servicesenter</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slettebakken menighets eldresenter</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bergen</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strandebarmheimen</name>
      <address>
        <city>Kvam</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toloheimen</name>
      <address>
        <city>Kvam</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Øysteseheimen</name>
      <address>
        <city>Kvam</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borgen sykehjem</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eplehagen bofellesskap</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haugvoll sykehjem</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsehuset</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurland</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tingvoll sykehjem</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valaskjold omsorgssenter</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundheimen</name>
      <address>
        <city>Sund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tednebakkane omsorgssenter</name>
      <address>
        <city>Øygarden</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.uib.no/sefas</url>
    <description>Centre for Elderly and Nursing Home Medicine</description>
  </link>
  <reference>
    <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>
    <PMID>26374231</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>April 14, 2016</last_update_submitted>
  <last_update_submitted_qc>April 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Bettina Husebo</investigator_full_name>
    <investigator_title>MD, assoc prof.</investigator_title>
  </responsible_party>
  <keyword>Nursing homes</keyword>
  <keyword>Dementia</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Geriatrics</keyword>
  <keyword>Aged</keyword>
  <keyword>Activities of Daily Living</keyword>
  <keyword>Pain</keyword>
  <keyword>Pain management</keyword>
  <keyword>Advance Care Planning</keyword>
  <keyword>Patient Safety</keyword>
  <keyword>Costs and Cost Analysis</keyword>
  <keyword>Medication Errors</keyword>
  <keyword>Medical Order Entry Systems</keyword>
  <keyword>Medication Reconciliation</keyword>
  <keyword>Medication Therapy Management</keyword>
  <keyword>Depression</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <keyword>Informed Consent</keyword>
  <keyword>Presumed Consent</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Apathy</keyword>
  <keyword>Hospitalization</keyword>
  <keyword>Mortality</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238652
org study id: 222113
nct id: NCT02238652
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Neuropsychiatric symptoms
time frame: 9 months
description: Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).
measure: Quality of life
time frame: 9 months
description: Assessing quality of life by Qualidem, QUALID and EQ-5D.
measure: Activities of daily living
time frame: 9 months
description: Assessed by ADL index (range 0-18).
measure: Mood or depression
time frame: 9 months
description: Assessed by Cornell Depression Scale (range 0-38)
measure: Pain
time frame: 9 months
description: Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)
measure: Medication review
time frame: 9 months
description: Use of medication in number of people and dose, especially use of psychotropic drugs
measure: Drug-related problems
time frame: 9 months
description: 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.
measure: Admission to hospital and mortality
time frame: 9 months
description: Questionnaire asking nurses wether the patient has been admitted to the hospital at month 4 and month 9.
measure: Cost-effectiveness
time frame: 9 months
description: Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)
measure: Cost of medication
time frame: 9 months
description: Cost-utility analysis will be performed
measure: Measure of activity
time frame: 9 months
description: ActiWatch to register sleep and activity
measure: Nursing home activity
time frame: 9 months
description: Log registration of NH activities
measure: Relatives satisfaction with conducted KOSMOS elements
time frame: 9 months
description: Relatives satisfaction with conducted KOSMOS elements with questionary
measure: Implementation indicators
time frame: 9 months
description: Assessment of the quality of the implementation on each intervention by monthly visits and phone calls and review of the manuals.
arm group label: Control
arm group type: No Intervention
arm group label: Intervention
arm group type: Active Comparator
description: Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety
intervention type: Behavioral
intervention name: Communication
description: A preparation process before the patient become incapable of participating in life prolonging decisions
arm group label: Intervention
other name: advance care planning
intervention type: Behavioral
intervention name: Systematic Pain Assessment and Treatment
description: Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
arm group label: Intervention
other name: MOBID-2
intervention type: Behavioral
intervention name: Medication Review
description: An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.
arm group label: Intervention
intervention type: Behavioral
intervention name: Occupational therapy
description: Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.
arm group label: Intervention
intervention type: Behavioral
intervention name: Safety
description: Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.
arm group label: Intervention
other name: patient safety
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Bettina S. Husebø, MD, PhD
role: Study Director
affiliation: University of Bergen
last name: Elisabeth Flo, PysD, PhD
role: Principal Investigator
affiliation: University of Bergen
last name: Irene Aasmul, Master
role: Principal Investigator
affiliation: University of Bergen
last name: Christine Gulla, MD
role: Principal Investigator
affiliation: University of Bergen
last name: Torstein Habiger
role: Principal Investigator
affiliation: University of Bergen
last name: Tony Elvegaard
role: Principal Investigator
affiliation: University of Bergen
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country: Norway
url: http://www.uib.no/sefas
description: Centre for Elderly and Nursing Home Medicine
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.
PMID: 26374231
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Bettina Husebo
investigator title: MD, assoc prof.