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Implementation and Evaluation of the COTiD Program in the Netherlands

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
3-day post-graduate course
Combined implementation strategy
Sponsored by
ZonMw: The Netherlands Organisation for Health Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring Occupational Therapy, Evidence-Based Practice, Continuing Education, utilization, Guideline, Dementia, Guideline implementation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Because of the clustered design, there are inclusion and exclusion criteria for clusters as well as for clients with dementia and their caregivers.A cluster is a unit that exists of at least one occupational therapist, one physician, and one manager.

Criteria for clusters

Inclusion Criteria:

  • The organization provides outpatient OT.
  • The organization expects that they will be able to include a minimum of 8 clients in the study.
  • There are at least two OTs, one manager, and one physician willing and able to participate in the study.

Exclusion Criteria:

  • The organization does not provide OT or outpatient treatment and is not allowed to refer to OT services in their area that do provide community OT.
  • Less than 8 clients are available per year to refer to the OT.
  • Physicians, managers or OTs are not willing to participate
  • Members of the board of directors responsible for the organization do not agree to participate

Criteria for client with dementia and their informal caregiver

Inclusion Criteria for clients and informal caregivers:

  • Client has mild to moderate dementia (MMSE score 10-24, DSM IV criteria for dementia)
  • Client lives at home
  • Client has an informal caregiver who takes care of the client at least twice a week

Exclusion criteria for clients:

  • Client is in a severe stage of dementia
  • Client has a depression (GDS (version 30) >12)
  • Client has severe behavioral or psychological symptoms in dementia (BPSD)
  • Client has a severe illness at the time of inclusion

Exclusion criteria for informal caregivers:

  • The caregiver is not able to participate in the OT treatment (e.g. due to illness).

Sites / Locations

  • Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

3-day post-graduate course

Combined implementation strategy

Arm Description

3-day post-graduate course on the use of the COTiD program in clinical practice

The combined implementation strategy

Outcomes

Primary Outcome Measures

Adherence of occupational therapists to the COTiD program
Adherence is measured using vignettes. Vignettes are realistic case descriptions about which occupational therapists are asked to answer open ended questions.
Community occupational therapy use according to the COTiD program
Community OT use reflects: How many people with dementia were referred to OT services in total How many people with dementia were referred specifically to OT according to the COTiD program.
Costs of the implementation strategies
The following cost data is collected: Costs of the implementation strategies Costs made by the OTs, managers, and physicians receiving the combined implementation strategy. Costs made by the OTs receiving only the educational strategy. Development and execution costs of the combined implementation strategy. development and execution costs of the educational strategy. Costs made buy the cliënt and caregiver Costs made by client and caregiver (using the RUD Lite instrument)regarding healthcare consumption Time the caregiver spends om informal care

Secondary Outcome Measures

Knowledge of the healthcare professionals about the COTiD program
measured using a multiple choice knowledge test on the most important aspects of the COTiD program.
COTiD program treatment outcome on client and caregiver level
The following outcomes are evaluated: Clients'processing skills (Assessment of Motor and Process Skills) Need for assistance in daily activities (Interview of Deterioration of Daily Activities in Dementia) Caregivers Sense of Competence (Sense of Competense Questionnaire) Client and caregiver quality of life (EQ5D and Dementia Quality of Life Scale) Client and caregiver self-perceived performance and satisfaction (Canadian Occupational Performance Measure)

Full Information

First Posted
May 3, 2010
Last Updated
May 20, 2010
Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
HAN University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01117285
Brief Title
Implementation and Evaluation of the COTiD Program in the Netherlands
Official Title
Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
HAN University of Applied Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this cluster randomized controlled trial is to evaluate the difference in effectiveness between a combined implementation strategy and an educational strategy on the implementation of a community occupational therapy program for clients with dementia and their primary caregivers.
Detailed Description
Dementia is associated with a major decrease in quality of life of clients and their caregivers and a major driver of costs in health care. Recently, evidence was found for the effectiveness and cost-effectiveness of a community-based occupational therapy (OT) intervention for older adults with dementia and their caregivers (COTiD program). This intervention resulted in significant improvements in both clients' and caregivers' daily functioning, quality of life, mood and health status. In addition, caregivers experienced an increased sense of competence. Currently occupational therapists (OTs) are trained in using the program during a 3-day course. In a pilot implementation study it was found that this course was not effective enough as only 20% of the OTs actually used the COTiD program in practice because of a lack of implementation skills, feedback and organisational barriers. In order to increase the use of this program and increase the quality of care a new implementation strategy is developed. This combined implementation strategy provides the OTs with two implementation training days, coaching on the job, regional meetings, discussion platform, web-based registration system and newsletters. In addition physicians and managers are provided with extra information on the COTiD program. The current study is designed primarily to evaluate the following research questions: What is the difference in adherence to the community OT guideline in dementia between OTs receiving the combined implementation strategy and OTs receiving the educational strategy? What is the difference in community OT use(referral rate + actual provision of OT) between clusters provided with the combined implementation strategy and clusters provided with the educational strategy? What is the difference in cost-effectiveness between the combined implementation strategy and the educational strategy with regard to adherence of OTs to the community OT guideline? In addition the effect of the implementation strategies on patient and caregiver outcomes will also be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Occupational Therapy, Evidence-Based Practice, Continuing Education, utilization, Guideline, Dementia, Guideline implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3-day post-graduate course
Arm Type
Active Comparator
Arm Description
3-day post-graduate course on the use of the COTiD program in clinical practice
Arm Title
Combined implementation strategy
Arm Type
Experimental
Arm Description
The combined implementation strategy
Intervention Type
Other
Intervention Name(s)
3-day post-graduate course
Other Intervention Name(s)
educational strategy
Intervention Description
A 3-day course in using the COTiD program in clinical practice. The 3 days are not provided uninterrupted but there are at least two weeks between each day to provide time to practice with the guideline (for discussion on the 2nd day). The course consists of theory on the content of the guideline and its effectiveness, Practice parts of the guideline by rol playing, and discussing each others skills through watching video material.
Intervention Type
Other
Intervention Name(s)
Combined implementation strategy
Other Intervention Name(s)
implementation training
Intervention Description
The combined implementation strategy provides strategies for occupational therapists (OTs), physicians, and managers. OTs receive: 3-day post-graduate course 2 extra training days: Lectures and skills practice focused on using the COTiD program and promoting the use of the program within their organization and network. Coaching on the job: Barriers to using the COTiD program in practice are discussed using motivational interviewing. Discussion platform Web-based registration system: Provides guidance in using the COTiD program for every individual client. Regional meetings: successes and difficulties in using the COTiD are discussed. Managers and physicians receive: Information on the COTiD program through a website and newsletters. Motivational reminders.
Primary Outcome Measure Information:
Title
Adherence of occupational therapists to the COTiD program
Description
Adherence is measured using vignettes. Vignettes are realistic case descriptions about which occupational therapists are asked to answer open ended questions.
Time Frame
one year (baseline, T1, and T2)
Title
Community occupational therapy use according to the COTiD program
Description
Community OT use reflects: How many people with dementia were referred to OT services in total How many people with dementia were referred specifically to OT according to the COTiD program.
Time Frame
one year
Title
Costs of the implementation strategies
Description
The following cost data is collected: Costs of the implementation strategies Costs made by the OTs, managers, and physicians receiving the combined implementation strategy. Costs made by the OTs receiving only the educational strategy. Development and execution costs of the combined implementation strategy. development and execution costs of the educational strategy. Costs made buy the cliënt and caregiver Costs made by client and caregiver (using the RUD Lite instrument)regarding healthcare consumption Time the caregiver spends om informal care
Time Frame
October 2009 - December 2011
Secondary Outcome Measure Information:
Title
Knowledge of the healthcare professionals about the COTiD program
Description
measured using a multiple choice knowledge test on the most important aspects of the COTiD program.
Time Frame
one year (baseline, T1, and T2)
Title
COTiD program treatment outcome on client and caregiver level
Description
The following outcomes are evaluated: Clients'processing skills (Assessment of Motor and Process Skills) Need for assistance in daily activities (Interview of Deterioration of Daily Activities in Dementia) Caregivers Sense of Competence (Sense of Competense Questionnaire) Client and caregiver quality of life (EQ5D and Dementia Quality of Life Scale) Client and caregiver self-perceived performance and satisfaction (Canadian Occupational Performance Measure)
Time Frame
one year (baseline, T1, and T2)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Because of the clustered design, there are inclusion and exclusion criteria for clusters as well as for clients with dementia and their caregivers.A cluster is a unit that exists of at least one occupational therapist, one physician, and one manager. Criteria for clusters Inclusion Criteria: The organization provides outpatient OT. The organization expects that they will be able to include a minimum of 8 clients in the study. There are at least two OTs, one manager, and one physician willing and able to participate in the study. Exclusion Criteria: The organization does not provide OT or outpatient treatment and is not allowed to refer to OT services in their area that do provide community OT. Less than 8 clients are available per year to refer to the OT. Physicians, managers or OTs are not willing to participate Members of the board of directors responsible for the organization do not agree to participate Criteria for client with dementia and their informal caregiver Inclusion Criteria for clients and informal caregivers: Client has mild to moderate dementia (MMSE score 10-24, DSM IV criteria for dementia) Client lives at home Client has an informal caregiver who takes care of the client at least twice a week Exclusion criteria for clients: Client is in a severe stage of dementia Client has a depression (GDS (version 30) >12) Client has severe behavioral or psychological symptoms in dementia (BPSD) Client has a severe illness at the time of inclusion Exclusion criteria for informal caregivers: The caregiver is not able to participate in the OT treatment (e.g. due to illness).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrra Vernooij-Dassen, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maud Graff, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17114212
Citation
Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Rikkert MG. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial. BMJ. 2006 Dec 9;333(7580):1196. doi: 10.1136/bmj.39001.688843.BE. Epub 2006 Nov 17.
Results Reference
background
PubMed Identifier
18171718
Citation
Graff MJ, Adang EM, Vernooij-Dassen MJ, Dekker J, Jonsson L, Thijssen M, Hoefnagels WH, Rikkert MG. Community occupational therapy for older patients with dementia and their care givers: cost effectiveness study. BMJ. 2008 Jan 19;336(7636):134-8. doi: 10.1136/bmj.39408.481898.BE. Epub 2008 Jan 2.
Results Reference
background
PubMed Identifier
19799779
Citation
Voigt-Radloff S, Graff M, Leonhart R, Schornstein K, Vernooij-Dassen M, Olde-Rikkert M, Huell M. WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres. BMC Geriatr. 2009 Oct 2;9:44. doi: 10.1186/1471-2318-9-44.
Results Reference
background
PubMed Identifier
17895439
Citation
Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Olderikkert MG. Effects of community occupational therapy on quality of life, mood, and health status in dementia patients and their caregivers: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2007 Sep;62(9):1002-9. doi: 10.1093/gerona/62.9.1002.
Results Reference
background
PubMed Identifier
25547113
Citation
Dopp CM, Graff MJ, Teerenstra S, Olde Rikkert MG, Nijhuis-van der Sanden MW, Vernooij-Dassen MJ. Effectiveness of a training package for implementing a community-based occupational therapy program in dementia: a cluster randomized controlled trial. Clin Rehabil. 2015 Oct;29(10):974-86. doi: 10.1177/0269215514564699. Epub 2014 Dec 28.
Results Reference
derived
PubMed Identifier
23718565
Citation
Dopp CM, Graff MJ, Teerenstra S, Nijhuis-van der Sanden MW, Olde Rikkert MG, Vernooij-Dassen MJ. Effectiveness of a multifaceted implementation strategy on physicians' referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial. BMC Fam Pract. 2013 May 30;14:70. doi: 10.1186/1471-2296-14-70.
Results Reference
derived
PubMed Identifier
21450063
Citation
Dopp CM, Graff MJ, Teerenstra S, Adang E, Nijhuis-van der Sanden RW, Olderikkert MG, Vernooij-Dassen MJ. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial. BMC Geriatr. 2011 Mar 30;11:13. doi: 10.1186/1471-2318-11-13.
Results Reference
derived

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Implementation and Evaluation of the COTiD Program in the Netherlands

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