Continuing Education in Nursing Home Dementia Care (MEDCED)

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Agitation
• Intervention / Treatment: Behavioral: Educational intervention

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)

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Askoy, Norway, 5307
    • Ask bo- og omsorgssenter
  • Bergen, Norway, 5005
    • Stiftelsen Nykirkehjemmet
  • Bergen, Norway, 5097
    • Landaas Meninghets Eldresenter
  • Bergen, Norway, 5873
    • Midtbygda sykehjem
  • Bomlo, Norway, 5440
    • Teiglandshagen bufellesskap
  • Eidfjord, Norway, 5783
    • Bygdaheimen
  • Gulen, Norway, 5966
    • Gulen Sjukeheim
  • Laerdal, Norway, 6887
    • Laerdal Alders- og Sjukeheim
  • Odda, Norway, 5760
    • Roldal pleie og omsorgstjeneste
  • Sandnes, Norway, 4307
    • Byhagen Bo og Aktivitetssenter
  • Sogndal, Norway, 6856
    • Sogndal Omsorgssenter
  • Stavanger, Norway, 4016
    • Bergåstjern Sykehjem
  • Stavanger, Norway, 4032
    • Boganes Bokollektiv
  • Stavanger, Norway, 4085
    • Oyane Sykehjem
  • Tysnes, Norway, 5685
    • Tysnes Sjukeheim
  • Tysvaer, Norway, 5575
    • Tysvaertunet
  • Flora
    • Florø, Flora, Norway, 6900
      • Flora Omsorgssenter
    • Florø, Flora, Norway, 6900
      • Furuhaugane Omsorgssenter
  • Gjesdal
    • Ålgård, Gjesdal, Norway, 4330
      • Solas bo- og rehabiliteringssenter
  • Kvinnherad
    • Rosendal, Kvinnherad, Norway, 5470
      • Husnestunet
    • Rosendal, Kvinnherad, Norway, 5470
      • Rosendalstunet
  • Kvitsoy
    • Stavanger, Kvitsoy, Norway, 4180
      • Kvitsoy kombisenter
  • Luster
    • Sogndal, Luster, Norway, 6868
      • Luster Sjukeheimsteneste, avd. Gaupne
  • Samnanger
    • Bergen, Samnanger, Norway, 5650
      • Samnangerheimen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Dementia

Exclusion Criteria:

• non-dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention; Educational intervention with two days of lecture/course for the whole staff in the selected department in each nursing home and six monthly sessions of counselling in smaller groups	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bergen University College
• Collaborators: The Research Council of Norway
• Investigators: Study Director: Frode F Jacobsen, PhD, Bergen University College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Dementia; Agitation; Resident; Nursinghome; Use of restraint
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Dementia
• Other Study ID Numbers: 2012/304