Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (KOSMOS)
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|ClinicalTrials.gov Identifier: NCT02238652|
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : April 15, 2016
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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.
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Behavioral: Communication Behavioral: Systematic Pain Assessment and Treatment Behavioral: Medication Review Behavioral: Occupational therapy Behavioral: Safety||Not Applicable|
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:
- 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.
- 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.
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
|No Intervention: Control|
Active Comparator: Intervention
Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety
A preparation process before the patient become incapable of participating in life prolonging decisions
Other Name: advance care planning
Behavioral: Systematic Pain Assessment and Treatment
Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
Other Name: 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.
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 Name: patient safety
- Neuropsychiatric symptoms [ Time Frame: 9 months ]Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).
- Quality of life [ Time Frame: 9 months ]Assessing quality of life by Qualidem, QUALID and EQ-5D.
- Activities of daily living [ Time Frame: 9 months ]Assessed by ADL index (range 0-18).
- Mood or depression [ Time Frame: 9 months ]Assessed by Cornell Depression Scale (range 0-38)
- Pain [ Time Frame: 9 months ]Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)
- Medication review [ Time Frame: 9 months ]Use of medication in number of people and dose, especially use of psychotropic drugs
- Drug-related problems [ Time Frame: 9 months ]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.
- Admission to hospital and mortality [ Time Frame: 9 months ]Questionnaire asking nurses wether the patient has been admitted to the hospital at month 4 and month 9.
- Cost-effectiveness [ Time Frame: 9 months ]Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)
- Cost of medication [ Time Frame: 9 months ]Cost-utility analysis will be performed
- Measure of activity [ Time Frame: 9 months ]ActiWatch to register sleep and activity
- Nursing home activity [ Time Frame: 9 months ]Log registration of NH activities
- Relatives satisfaction with conducted KOSMOS elements [ Time Frame: 9 months ]Relatives satisfaction with conducted KOSMOS elements with questionary
- Implementation indicators [ Time Frame: 9 months ]Assessment of the quality of the implementation on each intervention by monthly visits and phone calls and review of the manuals.
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|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Resident in long time care ward in Bergen, Bærum, Sarpsborg, Kvam, Fjell, Sund, Askøy and Øygarden
- Dying patients with reduced consciousness at baseline
- Active Schizophrenia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238652
|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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Bettina Husebo, MD, assoc prof., University of Bergen|
|Other Study ID Numbers:||
|First Posted:||September 12, 2014 Key Record Dates|
|Last Update Posted:||April 15, 2016|
|Last Verified:||September 2014|
Quality of Life
Activities of Daily Living
Advance Care Planning
Costs and Cost Analysis
Medical Order Entry Systems
Medication Therapy Management