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

Study Overview
=================
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: 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.

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

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Communication
* Behavioral: Systematic Pain Assessment and Treatment
* Behavioral: Medication Review
* Behavioral: Occupational therapy
* Behavioral: Safety


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Intervention<br>Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety | Behavioral: Communication<br>* A preparation process before the patient become incapable of participating in life prolonging decisions<br>* Other names: advance care planning;Behavioral: Systematic Pain Assessment and Treatment<br>* Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.<br>* Other names: MOBID-2;Behavioral: Medication Review<br>* An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.<br>Behavioral: Occupational therapy<br>* Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.<br>Behavioral: Safety<br>* Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.<br>* Other names: patient safety;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living | Assessed by ADL index (range 0-18). | 9 months | 
| Mood or depression | Assessed by Cornell Depression Scale (range 0-38) | 9 months | 
| Pain | Assessed by Mobilisation-Observation-Behaviour-Intensity-Dementia (MOBID-2) Pain Scale (range 0-10) | 9 months | 
| Medication review | Use of medication in number of people and dose, especially use of psychotropic drugs | 9 months | 
| 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 | 
| 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 | 
| Cost-effectiveness | Resource use will be registered by Resource use in dementia - formal care (RUD-FOCA) | 9 months | 
| Cost of medication | Cost-utility analysis will be performed | 9 months | 
| Measure of activity | ActiWatch to register sleep and activity | 9 months | 
| Nursing home activity | Log registration of NH activities | 9 months | 
| Relatives satisfaction with conducted KOSMOS elements | Relatives satisfaction with conducted KOSMOS elements with questionary | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nursing homes, Dementia, Quality of Life, Geriatrics, Aged, Activities of Daily Living, Pain, Pain management, Advance Care Planning, Patient Safety, Costs and Cost Analysis, Medication Errors, Medical Order Entry Systems, Medication Reconciliation, Medication Therapy Management, Depression, Psychotropic Drugs, Informed Consent, Presumed Consent, Anxiety, Apathy, Hospitalization, Mortality