Implementation and Evaluation of the COTiD Program in the Netherlands

Not Applicable

• Conditions: Dementia
• Interventions: Other: 3-day post-graduate course; Other: Combined implementation strategy

• Registration Number: NCT01117285
• Lead Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development

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.

Study Timeline

• Study Start: 2009-10
• Status Verified: 2010-03
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Last Update Submitted: 2010-05-20
• Last Update Posted: 2010-05-21
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-day post-graduate course	3-day post-graduate course	3-day post-graduate course on the use of the COTiD program in clinical practice
Combined implementation strategy	Combined implementation strategy	The combined implementation strategy

Primary Outcome Measures

Name	Time	Method
Adherence of occupational therapists to the COTiD program	one year (baseline, T1, and T2)	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	one year	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	October 2009 - December 2011	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

Name	Time	Method
Knowledge of the healthcare professionals about the COTiD program	one year (baseline, T1, and T2)	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	one year (baseline, T1, and T2)	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)

Trial Locations

Locations (1)

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