Implementation and Evaluation of the COTiD Program in the Netherlands

NCT ID: NCT01117285

Last Updated: 2010-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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3-day post-graduate course

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

Group Type ACTIVE_COMPARATOR

3-day post-graduate course

Intervention Type OTHER

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.

Combined implementation strategy

The combined implementation strategy

Group Type EXPERIMENTAL

Combined implementation strategy

Intervention Type OTHER

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.

Interventions

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3-day post-graduate course

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

Combined implementation strategy

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.

Intervention Type OTHER

Other Intervention Names

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educational strategy implementation training

Eligibility Criteria

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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.


* 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

Criteria for clusters


* 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


* 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


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

ALL

Accepts Healthy Volunteers

No

Sponsors

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HAN University of Applied Sciences

OTHER

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Scientific Institute for Quality of Healthcare (IQ healthcare), Radboud University Nijmegen Medical Centre

Principal Investigators

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Myrra Vernooij-Dassen, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Maud Graff, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 17114212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18171718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19799779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17895439 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25547113 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23718565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21450063 (View on PubMed)

Other Identifiers

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80-82315-98-090010

Identifier Type: -

Identifier Source: org_study_id

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