Continuing Education in Nursing Home Dementia Care (MEDCED)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dementia Agitation |
Behavioral: Educational intervention Other: Educational intervention |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care |
- Restraint change [ Time Frame: Assessment in 6-8 months, publication in approximately 18-20 months ] [ Designated as safety issue: No ]Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.
- Psychotropic drug change [ Time Frame: Assessment in 6-8 months, publication in approximately 18-20 months ] [ Designated as safety issue: No ]Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.
| Estimated Enrollment: | 220 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other: Educational intervention
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Dementia
Exclusion Criteria:
- non-dementia
Contacts and Locations| Contact: Frode F Jacobsen, PhD | 55587500 | ffj@hib.no |
| Norway | |
| Furuhaugane Omsorgssenter | Recruiting |
| Florø, Flora, Norway, 6900 | |
| Contact: Ann K Hovland +47 75 69 00 ann.kristin.hovland@flora.kommune.no | |
| Flora Omsorgssenter | Recruiting |
| Florø, Flora, Norway, 6900 | |
| Contact: Ann K Hovland +47 57 75 67 70 ann.kristine.hovland@flora.kommune.no | |
| Solas bo- og rehabiliteringssenter | Recruiting |
| Ålgård, Gjesdal, Norway, 4330 | |
| Contact: Oddny Bjorland +47 51 61 13 70 oddny.bjorland@gjesdal.kommune.no | |
| Rosendalstunet | Recruiting |
| Rosendal, Kvinnherad, Norway, 5470 | |
| Contact: Aslaug Hellesoy +47 53 48 31 00 aslaug.hellesoy@kvinnherad.kommune.no | |
| Husnestunet | Recruiting |
| Rosendal, Kvinnherad, Norway, 5470 | |
| Contact: Siv Handeland +47 53 54 17 00 siv.handeland@kvinnherad.kommune.no | |
| Kvitsoy kombisenter | Recruiting |
| Stavanger, Kvitsoy, Norway, 4180 | |
| Contact: Malene Soyland +47 51 73 63 50 malene.soyland@kvitsoy.kommune.no | |
| Luster Sjukeheimsteneste, avd. Gaupne | Recruiting |
| Sogndal, Luster, Norway, 6868 | |
| Contact: Tone Thomassen +47 57 68 57 00 tone.kristin.thomassen@luster.kommune.no | |
| Samnangerheimen | Recruiting |
| Bergen, Samnanger, Norway, 5650 | |
| Contact: Reidun Abotnes +47 56 58 98 50 reidun.abotnes@samnanger.kommune.no | |
| Ask bo- og omsorgssenter | Recruiting |
| Askoy, Norway, 5307 | |
| Contact: Linda Lystrup +47 56 15 76 00 linda.lystrup@ask-omsorgssenter.no | |
| Midtbygda sykehjem | Recruiting |
| Bergen, Norway, 5873 | |
| Contact: Kari Hovland +47 55 53 72 00 kari.hovland@bergen.kommune.no | |
| Stiftelsen Nykirkehjemmet | Recruiting |
| Bergen, Norway, 5005 | |
| Contact: Bjarte Aarland +47 55 54 49 30 bjarte.aarland@nykirkehjemmet.no | |
| Landaas Meninghets Eldresenter | Recruiting |
| Bergen, Norway, 5097 | |
| Contact: Bjorg S Nguyen +47 55 27 72 00 bsn@lme.no | |
| Teiglandshagen bufellesskap | Recruiting |
| Bomlo, Norway, 5440 | |
| Contact: Maj-Tove Meling +47 53 42 37 90 maj.tove.meling@bomlo.kommune.no | |
| Bygdaheimen | Recruiting |
| Eidfjord, Norway, 5783 | |
| Contact: Margunn Laegreid +47 53 67 35 60 margunn.laegreid@eidfjord.kommune.no | |
| Gulen Sjukeheim | Recruiting |
| Gulen, Norway, 5966 | |
| Contact: Nina Haveland +47 57 78 16 00 nina.haveland@gulen.kommmune.no | |
| Laerdal Alders- og Sjukeheim | Recruiting |
| Laerdal, Norway, 6887 | |
| Contact: Liv Overland +47 57 64 12 00 liv.overland@laerdal.kommune.no | |
| Roldal pleie og omsorgstjeneste | Recruiting |
| Odda, Norway, 5760 | |
| Contact: Grete Gronnestad +47 53 65 48 43 grete.gronnestad@odda.kommune.no | |
| Byhagen Bo og Aktivitetssenter | Recruiting |
| Sandnes, Norway, 4307 | |
| Contact: Sissel B Amundsen +47 51 97 21 00 sissel.b.amundsen@sandnes.kommune.no | |
| Sogndal Omsorgssenter | Recruiting |
| Sogndal, Norway, 6856 | |
| Contact: Lillian Dalaker +47 57 62 96 00 lillian.dalaker@sogndal.kommune.no | |
| Bergåstjern Sykehjem | Recruiting |
| Stavanger, Norway, 4016 | |
| Contact: Kari Aamodt +47 51 90 69 50 kari.l.aamodt@stavanger.kommune.no | |
| Boganes Bokollektiv | Recruiting |
| Stavanger, Norway, 4032 | |
| Contact: Elin Borge +47 51 91 22 29 elin.borge@stavanger.kommune.no | |
| Oyane Sykehjem | Recruiting |
| Stavanger, Norway, 4085 | |
| Contact: Anne I Osmundsen +47 51 85 69 20 anne.irene.osmundsen@stavanger.kommune.no | |
| Tysnes Sjukeheim | Recruiting |
| Tysnes, Norway, 5685 | |
| Contact: Helga N Boland +47 53 43 08 00 helga.n.boland@tysnes.kommune.no | |
| Tysvaertunet | Recruiting |
| Tysvaer, Norway, 5575 | |
| Contact: Anne M Larsen +47 52 75 87 05 amlarsen@tysver.kommune.no | |
| Study Director: | Frode F Jacobsen, PhD | Bergen University College |
More Information
No publications provided
| Responsible Party: | Frode F. Jacobsen, Professor, Director, Bergen University College |
| ClinicalTrials.gov Identifier: | NCT01715506 History of Changes |
| Other Study ID Numbers: | 2012/304 |
| Study First Received: | October 25, 2012 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Bergen University College:
|
Dementia Resident Nursinghome Use of restraint Agitation |
Additional relevant MeSH terms:
|
Dementia Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013