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

Sponsor

University of Bergen (Other)

Overall Status

Completed

CT.gov ID

NCT02238652

Collaborator

The Research Council of Norway (Other), Rebekka Ege Hegemanns legat (Other), Helse Stavanger HF (Other), University of Oslo (Other), King's College London (Other), Karolinska Institutet (Other)

560

Enrollment

Locations

Arms

Duration (Months)

17.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

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	N/A

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

560 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

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 :

Aug 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Implementation indicators [9 months]
Assessment of the quality of the implementation on each intervention by monthly visits and phone calls and review of the manuals.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Solvik	Baerum	Akershus	Norway	1304
2	Donski Bo og behandlingssenter	Baerum	Akershus	Norway	1346
3	Mariehaven Bo og behandlingssenter	Baerum	Akershus	Norway	1346
4	Berger Bo og Behandlingssenter	Baerum	Akershus	Norway	1349
5	Kolaashjemmet Bo og Behandlingssenter	Baerum	Akershus	Norway	1352
6	Gullhaug Bo og behandlingssenter	Baerum	Akershus	Norway	1354
7	Osteraas Bo og behandlingssenter	Baerum	Akershus	Norway	1361
8	Solbakken Bo og Behandlingssenter	Baerum	Akershus	Norway	1361
9	Lønnås Bo og Rehabsenter	Baerum	Akershus	Norway	1362
10	Nordraaksvei bo og behandlingssenter	Baerum	Akershus	Norway	1369
11	Stabaekktunet Bo og behandlingssenter	Baerum	Akershus	Norway	1369
12	Stabekk Bo og Behandlingssenter	Baerum	Akershus	Norway	1369
13	Ask bo og omsorgssenter	Askøy		Norway
14	Arna helseheim	Bergen		Norway
15	Frieda Fasmers minne	Bergen		Norway
16	Gullstøltunet Sykehjem	Bergen		Norway
17	Hospitalet Betanien	Bergen		Norway
18	Lyngbøtunet Bo og servicesenter	Bergen		Norway
19	Slettebakken menighets eldresenter	Bergen		Norway
20	University of Bergen	Bergen		Norway
21	Strandebarmheimen	Kvam		Norway
22	Toloheimen	Kvam		Norway
23	Øysteseheimen	Kvam		Norway
24	Borgen sykehjem	Sarpsborg		Norway
25	Eplehagen bofellesskap	Sarpsborg		Norway
26	Haugvoll sykehjem	Sarpsborg		Norway
27	Helsehuset	Sarpsborg		Norway
28	Kurland	Sarpsborg		Norway
29	Tingvoll sykehjem	Sarpsborg		Norway
30	Valaskjold omsorgssenter	Sarpsborg		Norway
31	Sundheimen	Sund		Norway
32	Tednebakkane omsorgssenter	Øygarden		Norway