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

Quality of Life Clinical Trial

— KOSMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238652
• Other study ID #: 222113
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: April 14, 2016
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2014
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• Communication
A preparation process before the patient become incapable of participating in life prolonging decisions
• Systematic Pain Assessment and Treatment
Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
• Medication Review
An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.
• Occupational therapy
Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.
• 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.

Locations

Country	Name	City	State
Norway	Ask bo og omsorgssenter	Askøy
Norway	Berger Bo og Behandlingssenter	Baerum	Akershus
Norway	Donski Bo og behandlingssenter	Baerum	Akershus
Norway	Gullhaug Bo og behandlingssenter	Baerum	Akershus
Norway	Kolaashjemmet Bo og Behandlingssenter	Baerum	Akershus
Norway	Lønnås Bo og Rehabsenter	Baerum	Akershus
Norway	Mariehaven Bo og behandlingssenter	Baerum	Akershus
Norway	Nordraaksvei bo og behandlingssenter	Baerum	Akershus
Norway	Osteraas Bo og behandlingssenter	Baerum	Akershus
Norway	Solbakken Bo og Behandlingssenter	Baerum	Akershus
Norway	Solvik	Baerum	Akershus
Norway	Stabaekktunet Bo og behandlingssenter	Baerum	Akershus
Norway	Stabekk Bo og Behandlingssenter	Baerum	Akershus
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	Bergen
Norway	Øysteseheimen	Kvam
Norway	Strandebarmheimen	Kvam
Norway	Toloheimen	Kvam
Norway	Tednebakkane omsorgssenter	Øygarden
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	Sarpsborg
Norway	Sundheimen	Sund

Sponsors (7)

Lead Sponsor	Collaborator
University of Bergen	Helse Stavanger HF, Karolinska Institutet, King's College London, Rebekka Ege Hegemanns legat, The Research Council of Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Neuropsychiatric symptoms	Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).	9 months	No
Primary	Quality of life	Assessing quality of life by Qualidem, QUALID and EQ-5D.	9 months	No
Secondary	Activities of daily living	Assessed by ADL index (range 0-18).	9 months	No
Secondary	Mood or depression	Assessed by Cornell Depression Scale (range 0-38)	9 months	No
Secondary	Pain	Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10)	9 months	No
Secondary	Medication review	Use of medication in number of people and dose, especially use of psychotropic drugs	9 months	No
Secondary	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	No
Secondary	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	No
Secondary	Cost-effectiveness	Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA)	9 months	No
Secondary	Cost of medication	Cost-utility analysis will be performed	9 months	No
Secondary	Measure of activity	ActiWatch to register sleep and activity	9 months	No
Secondary	Nursing home activity	Log registration of NH activities	9 months	No
Secondary	Relatives satisfaction with conducted KOSMOS elements	Relatives satisfaction with conducted KOSMOS elements with questionary	9 months	No

External Links

•   Centre for Elderly and Nursing Home Medicine