Implementation and Evaluation of the COTiD Program in the Netherlands

ZonMw: The Netherlands Organisation for Health Research and Development

Status: Unknown

Conditions: Dementia

Treatments: Other: 3-day post-graduate course; Other: Combined implementation strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01117285

80-82315-98-090010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

3-day post-graduate course

Active Comparator group

Description:

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

Treatment:

Other: 3-day post-graduate course

Combined implementation strategy

Experimental group

Description:

The combined implementation strategy

Treatment:

Other: Combined implementation strategy