Clinical trial NCT01715506: Continuing Education in Nursing Home Dementia Care
Official title: Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Agitation
Keywords: Dementia
Resident
Nursinghome
Use of restraint
Agitation
Lead sponsor: Bergen University College
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2012-10-29
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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)

Eligibility criteria: Inclusion Criteria:

* Dementia

Exclusion Criteria:

* non-dementia

Primary outcomes:
measure: Restraint change
timeFrame: Assessment in 6-8 months, publication in approximately 18-20 months
Secondary outcomes:
measure: Psychotropic drug change
timeFrame: Assessment in 6-8 months, publication in approximately 18-20 months
Other outcomes:
Locations:
city: Florø
country: Norway
facility: Flora Omsorgssenter
state: Flora
city: Florø
country: Norway
facility: Furuhaugane Omsorgssenter
state: Flora
city: Ålgård
country: Norway
facility: Solas bo- og rehabiliteringssenter
state: Gjesdal
city: Rosendal
country: Norway
facility: Husnestunet
state: Kvinnherad
city: Rosendal
country: Norway
facility: Rosendalstunet
state: Kvinnherad
city: Stavanger
country: Norway
facility: Kvitsoy kombisenter
state: Kvitsoy
city: Sogndal
country: Norway
facility: Luster Sjukeheimsteneste, avd. Gaupne
state: Luster
city: Bergen
country: Norway
facility: Samnangerheimen
state: Samnanger
city: Askoy
country: Norway
facility: Ask bo- og omsorgssenter
city: Bergen
country: Norway
facility: Stiftelsen Nykirkehjemmet
city: Bergen
country: Norway
facility: Landaas Meninghets Eldresenter
city: Bergen
country: Norway
facility: Midtbygda sykehjem
city: Bomlo
country: Norway
facility: Teiglandshagen bufellesskap
city: Eidfjord
country: Norway
facility: Bygdaheimen
city: Gulen
country: Norway
facility: Gulen Sjukeheim
city: Laerdal
country: Norway
facility: Laerdal Alders- og Sjukeheim
city: Odda
country: Norway
facility: Roldal pleie og omsorgstjeneste
city: Sandnes
country: Norway
facility: Byhagen Bo og Aktivitetssenter
city: Sogndal
country: Norway
facility: Sogndal Omsorgssenter
city: Stavanger
country: Norway
facility: Bergåstjern Sykehjem
city: Stavanger
country: Norway
facility: Boganes Bokollektiv
city: Stavanger
country: Norway
facility: Oyane Sykehjem
city: Tysnes
country: Norway
facility: Tysnes Sjukeheim
city: Tysvaer
country: Norway
facility: Tysvaertunet
Study officials:
affiliation: Bergen University College
name: Frode F Jacobsen, PhD
role: STUDY_DIRECTOR
References:
citation: Jacobsen FF, Mekki TE, Forland O, Folkestad B, Kirkevold O, Skar R, Tveit EM, Oye C. A mixed method study of an education intervention to reduce use of restraint and implement person-centered dementia care in nursing homes. BMC Nurs. 2017 Sep 18;16:55. doi: 10.1186/s12912-017-0244-0. eCollection 2017.