Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy
- Conditions
- Quality of Life
- Interventions
- Behavioral: CommunicationBehavioral: Systematic Pain Assessment and TreatmentBehavioral: Medication ReviewBehavioral: Occupational therapyBehavioral: Safety
- Registration Number
- NCT02238652
- Lead Sponsor
- University of Bergen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Communication Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety Intervention Medication Review Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety Intervention Systematic Pain Assessment and Treatment Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety Intervention Safety Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety Intervention Occupational therapy Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety
- Primary Outcome Measures
Name Time Method Quality of life 9 months Assessing quality of life by Qualidem, QUALID and EQ-5D.
Neuropsychiatric symptoms 9 months Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).
- Secondary Outcome Measures
Name Time Method Activities of daily living 9 months Assessed by ADL index (range 0-18).
Mood or depression 9 months Assessed by Cornell Depression Scale (range 0-38)
Pain 9 months Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)
Medication review 9 months Use of medication in number of people and dose, especially use of psychotropic drugs
Drug-related problems 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 9 months Questionnaire asking nurses wether the patient has been admitted to the hospital at month 4 and month 9.
Cost-effectiveness 9 months Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)
Cost of medication 9 months Cost-utility analysis will be performed
Measure of activity 9 months ActiWatch to register sleep and activity
Nursing home activity 9 months Log registration of NH activities
Relatives satisfaction with conducted KOSMOS elements 9 months Relatives satisfaction with conducted KOSMOS elements with questionary
Trial Locations
- Locations (32)
Donski Bo og behandlingssenter
🇳🇴Baerum, Akershus, Norway
Solbakken Bo og Behandlingssenter
🇳🇴Baerum, Akershus, Norway
Eplehagen bofellesskap
🇳🇴Sarpsborg, Norway
Kolaashjemmet Bo og Behandlingssenter
🇳🇴Baerum, Akershus, Norway
Osteraas Bo og behandlingssenter
🇳🇴Baerum, Akershus, Norway
Strandebarmheimen
🇳🇴Kvam, Norway
Mariehaven Bo og behandlingssenter
🇳🇴Baerum, Akershus, Norway
Berger Bo og Behandlingssenter
🇳🇴Baerum, Akershus, Norway
Arna helseheim
🇳🇴Bergen, Norway
Stabekk Bo og Behandlingssenter
🇳🇴Baerum, Akershus, Norway
Solvik
🇳🇴Baerum, Akershus, Norway
Gullhaug Bo og behandlingssenter
🇳🇴Baerum, Akershus, Norway
Gullstøltunet Sykehjem
🇳🇴Bergen, Norway
Hospitalet Betanien
🇳🇴Bergen, Norway
Lønnås Bo og Rehabsenter
🇳🇴Baerum, Akershus, Norway
Nordraaksvei bo og behandlingssenter
🇳🇴Baerum, Akershus, Norway
Øysteseheimen
🇳🇴Kvam, Norway
Frieda Fasmers minne
🇳🇴Bergen, Norway
Stabaekktunet Bo og behandlingssenter
🇳🇴Baerum, Akershus, Norway
Ask bo og omsorgssenter
🇳🇴Askøy, Norway
Lyngbøtunet Bo og servicesenter
🇳🇴Bergen, Norway
Toloheimen
🇳🇴Kvam, Norway
Slettebakken menighets eldresenter
🇳🇴Bergen, Norway
University of Bergen
🇳🇴Bergen, Norway
Borgen sykehjem
🇳🇴Sarpsborg, Norway
Tingvoll sykehjem
🇳🇴Sarpsborg, Norway
Haugvoll sykehjem
🇳🇴Sarpsborg, Norway
Helsehuset
🇳🇴Sarpsborg, Norway
Kurland
🇳🇴Sarpsborg, Norway
Valaskjold omsorgssenter
🇳🇴Sarpsborg, Norway
Sundheimen
🇳🇴Sund, Norway
Tednebakkane omsorgssenter
🇳🇴Øygarden, Norway