Person- Centred Care Among Nursing Home Patients With Dementia

Dementia Clinical Trial

Official title:

Person-centred Care and Dementia Care Mapping Among Nursing Home Patients - a 10 Months Randomised Controlled Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280890
• Other study ID #: PCCNor
• Secondary ID: 196326/V50
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: June 11, 2012
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Norwegian Centre for Ageing and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Dementia is a common and devastating disease in the elderly. No cure exist and there is an increasing need for care. To improve knowledge on how to provide better care for the patients with dementia in nursing homes, the investigators will carry out a controlled trial using two forms of education and developmental interventions towards the nursing home care staff: a structured framework (VIPS) and dementia care mapping (DCM)to develop person-centred care in a 10 months randomised controlled study. In accordance with the knowledge found in the literature the investigators hypothesize that both VIPS framework and DCM will be more effective than a traditional educational program about dementia provided to the staff in nursing homes. The positive effects will be seen as reduced agitation in patients, less use of psychotropic drugs and improved quality of life. Using VIPS framework and DCM will also have a better effect on staffs' well-being than traditional education in dementia. The aim of the study is to confirm or reject these hypotheses.

Description:

This is a controlled intervention trial with three groups of staff recruited from 15 nursing homes in the city of Oslo. The intervention will be carried out over 10 months. Randomization will be done at institutional level. Before randomization all patients in the participating nursing homes should be screened for dementia. This will be done by interviewing the registered nurses in the nursing homes using the Clinical dementia rating scale (CDR), Neuropsychiatric inventory (NPI-Q), Cornell scale for depression in dementia (CSDD). In addition information from the records will be used. Diagnosis of dementia will be made according to ICD-10 criteria, using a diagnostic algorithm that is evaluated in an ongoing nursing home study.

The nursing homes will be randomized in tree groups. Group A - Applying the VIPS- framework to develop Person Centred Care (PCC) and milieu therapy. The staff will be introduced to the model for applying the VIPS-framework to promote PCC in the daily care. A manual including films with information and examples will be distributed to all staff. Two auxiliary nurses are appointed as resource persons (RP) from each ward and one registered nurse (RN) from each nursing home will be trained as coach. The RPs and the leading registered nurse (RN) will plan and lead weekly consensus meetings with the staff in the ward using the VIPS-framework in discussions of concrete care situations. The researches will receive monthly written standard reports on attendance and contents of the consensus meetings from the RPs and can be contacted for support when necessary.

Group B - using Dementia Care Mapping (DCM) developing Person Centred Care and milieu therapy All staff and leaders in the nursing home will be introduced to the DCM- process in a presentation of the method and person centred care as a value base for DCM. A group of 3-5 staff members from each nursing home will be trained as DCM basic users. Dementia Care Mappings (4-6 hours) will be made in each unit in the nursing homes and feed-back (1, 5 hours) will be given to the staff within a week after the mapping. Based on the findings and the reflections in the feed-back session, action plans on how to develop care to selected patients and/or to the group of patients, will be created in the units. The project leader will be responsible for the introduction, mapping and feed-back sessions and give the necessary supervision to create action plans. The leaders and staff in the nursing home units will be responsible for the implementation of the changes to develop practice.The DCM-process will be repeated after 6-8 months

Group C (control group) - traditional education Lectures made as 5 DVD films lasting for 30 minutes, will be given to the nursing home staff on three themes: types of dementia, legal aspects of use of restraints and challenging behavior

The staff in group A and B will receive the same lectures as the staff in the control group.

Effect will be measured on patient and staff level, and measurements will be done at baseline and after 10 months of intervention. Data will be collected by research assistants, who will not take part in the three different intervention programs and not be employed by the nursing homes that are included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Persons with dementia living in nursing homes

• A score of 1,2 or 3 on the Clinical Dementia Rating Scale (CDR)

• The nursing staff in the wards where the patients are

Exclusion Criteria:

• Result from the inclusion criteria

Study Design

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

Related Conditions & MeSH terms

• Agitation
• Dementia

Intervention

Behavioral:
• Staff training using VIPS
Staff training using the VIPS framework
• Staff training using DCM
The staff will be supervised using Dementia Care Mapping
• Control group
Filmed traditional Lectures will be given to care staff

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Centre for Ageing and Health	The Research Council of Norway

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in agitation at 10 months from baseline using Brief Agitation Rating Scale	Brief Agitation Rating Scale (BARS)will be used to measure change in agitation from basline to end of intervention after 10 months	After 10 months	No
Secondary	Neuropsychiatric Inventory (NPI-Q)		After 10 months	No
Secondary	Cornell scale for depression in dementia		After 10 months	No
Secondary	Quality of life in Alzheimer's Disease (QUALID)		After 10 months	No
Secondary	Use of psychotropic drugs	collected from the patients' records	After 10 months	No
Secondary	Clinical Dementia Rating Scale (CDR)		After 10 months	No
Secondary	Lawton maintenance scale	Measures function in activities of daily living	After 10 months	No
Secondary	Person-centred Care Assessment Tool (P-CAT)		after 10 months	No
Secondary	QPSNordic	A scale developed to measure psychological and social factors in working life	After 10 months	No
Secondary	Stress of Conscience Questionaire (SCQ)	Assessing stressful situations experienced by staff and the degree to which they trouble the conscience	After10 months	No