Continuing Education in Nursing Home Dementia Care

Dementia Clinical Trial

— MEDCED  

Official title:

Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715506
• Other study ID #: 2012/304
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: July 22, 2016
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Bergen University College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

This is a single-blinded controlled cluster-randomized intervention trial recruiting staff from 24 NHs in three counties in the region of Western Norway, randomly selected from the total NH population in the region. A cluster is defined as a working ward of a larger NH, without shared facilities or staff. The 24 NHs are randomized into two groups, for intervention (12) and control (12). One department in each is selected for intervention and data collection will take place also in one department in each of the NHs in the control group. Hence the analyzed units (clusters) are NH departments. The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. A seven-month educational intervention will be performed, and due to ethical issues the control group will receive the same intervention after the second follow-up. Effects will be measured on resident and care staff level at baseline before randomization, after the intervention (7 months) and at follow-up (7 months later) of the intervention group.

Description:

Purpose:

Dementia is a major challenge for our society. In Norway, around 40 % of persons suffering from dementia live in nursing homes (NH), and the majority experiences severe functional impairments and complex needs including associated behavioral changes. International studies indicate that NH residents with cognitive impairment and high dependency are most likely to be restrained physically. There is evidence of various adverse effects such as injuries, reduced psychological well-being or decreased mobility related to the use of physical restraint. Moreover, in addition to ethical and professional arguments, there is evidence supporting that user-involvement and shared decision-making have positive effects for both residents and staff. The aim of the present study (MEDCED) is to carry out an educational intervention in care staff to test its potential effect on use of restraint in NH residents with dementia and increase job-satisfaction in care staff.

Description:

This is a single-blinded controlled cluster-randomized intervention trial recruiting staff from 24 NHs in three counties in the region of Western Norway, randomly selected from the total NH population in the region. A cluster is defined as a working ward of a larger NH, without shared facilities or staff. The 24 NHs are randomized into two groups, for intervention (12) and control (12). One department in each is selected for intervention and data collection will take place also in one department in each of the NHs in the control group. Hence the analyzed units (clusters) are NH departments. The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. A seven-month educational intervention will be performed, and due to ethical issues the control group will receive the same intervention after the second follow-up. Effects will be measured on resident and care staff level at baseline before randomization, after the intervention (7 months) and at follow-up (7 months later) of the intervention group.

An analysis of how many units needs to be included are based on 12+12 clusters. Two calculations have been performed. The first calculation is based on how big is the reduction in use of restraints. We assume in our model that there will be a 60 % reduction in use of restraints in the intervention group and 33 % reduction in the control group (Hawthorne effect). For this reason we need to include averagely 13 patients in each department/unit in order to achieve a statistical power of 0,8.

Measures on resident will be collected by a skilled research nurse blind to the study. Care staff measures will be collected through a questionnaire distributed directly to the care staff, provided with a stamped envelope to return the questionnaire directly to the research group. In addition, department characteristics (like type of department, staff coverage, architecture) will be registered.

A research team will lead the EI, and four facilitator teams each consisting of one nurse and one assistant professor from a nursing schools will be responsible for the EI of the decision-making model in the NHs. The Educational intervention will be carried out in two steps, firstly from researchers to the educators (EI 1) and secondly from the educators to the NH staff (EI 2)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria:

• Dementia

Exclusion Criteria:

• non-dementia

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Agitation
• Dementia
• Psychomotor Agitation

Intervention

Behavioral:
• Educational intervention
The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. Course material, a book particularly designed for this intervention and dealing with person centered care and use of restraint, is distributed ahead of the course part of the intervention to all participants.

Locations

Country	Name	City	State
Norway	Solas bo- og rehabiliteringssenter	Ålgård	Gjesdal
Norway	Ask bo- og omsorgssenter	Askoy
Norway	Landaas Meninghets Eldresenter	Bergen
Norway	Midtbygda sykehjem	Bergen
Norway	Samnangerheimen	Bergen	Samnanger
Norway	Stiftelsen Nykirkehjemmet	Bergen
Norway	Teiglandshagen bufellesskap	Bomlo
Norway	Bygdaheimen	Eidfjord
Norway	Flora Omsorgssenter	Florø	Flora
Norway	Furuhaugane Omsorgssenter	Florø	Flora
Norway	Gulen Sjukeheim	Gulen
Norway	Laerdal Alders- og Sjukeheim	Laerdal
Norway	Roldal pleie og omsorgstjeneste	Odda
Norway	Husnestunet	Rosendal	Kvinnherad
Norway	Rosendalstunet	Rosendal	Kvinnherad
Norway	Byhagen Bo og Aktivitetssenter	Sandnes
Norway	Luster Sjukeheimsteneste, avd. Gaupne	Sogndal	Luster
Norway	Sogndal Omsorgssenter	Sogndal
Norway	Bergåstjern Sykehjem	Stavanger
Norway	Boganes Bokollektiv	Stavanger
Norway	Kvitsoy kombisenter	Stavanger	Kvitsoy
Norway	Oyane Sykehjem	Stavanger
Norway	Tysnes Sjukeheim	Tysnes
Norway	Tysvaertunet	Tysvaer

Sponsors (2)

Lead Sponsor	Collaborator
Bergen University College	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restraint change	Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.	Assessment in 6-8 months, publication in approximately 18-20 months	No
Secondary	Psychotropic drug change	Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.	Assessment in 6-8 months, publication in approximately 18-20 months	No