Implementation and Evaluation of the COTiD Program in the Netherlands

Dementia Clinical Trial

Official title:

Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01117285
• Other study ID #: 80-82315-98-090010
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 3, 2010
• Last updated: May 20, 2010
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development	HAN University of Applied Sciences

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Graff MJ, Adang EM, Vernooij-Dassen MJ, Dekker J, Jönsson 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. — View 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. — View 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. Epub 2006 Nov 17. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year (baseline, T1, and T2)	No
Primary	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.	one year	No
Primary	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	October 2009 - December 2011	No
Secondary	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.	one year (baseline, T1, and T2)	No
Secondary	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)	one year (baseline, T1, and T2)	No