Implementation and Evaluation of the COTiD Program in the Netherlands

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
HAN University of Applied Sciences
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01117285
First received: May 3, 2010
Last updated: May 20, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Dementia
Other: 3-day post-graduate course
Other: Combined implementation strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Adherence of occupational therapists to the COTiD program [ Time Frame: one year (baseline, T1, and T2) ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]

    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 [ Time Frame: October 2009 - December 2011 ] [ Designated as safety issue: No ]

    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 [ Time Frame: one year (baseline, T1, and T2) ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year (baseline, T1, and T2) ] [ Designated as safety issue: No ]

    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)


Estimated Enrollment: 180
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3-day post-graduate course
3-day post-graduate course on the use of the COTiD program in clinical practice
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.

Other Name: educational strategy
Experimental: Combined implementation strategy
The combined implementation strategy
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.
Other Name: implementation training

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117285

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
HAN University of Applied Sciences
Investigators
Study Chair: Myrra Vernooij-Dassen, PhD Radboud University
Principal Investigator: Maud Graff, PhD Radboud University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. M.J.L. Graff / Senior research fellow, lecturer, Scientific Institute for Quality of Healthcare (IQ healthcare), Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT01117285     History of Changes
Other Study ID Numbers: 80-82315-98-090010
Study First Received: May 3, 2010
Last Updated: May 20, 2010
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Keywords provided by Radboud University:
Occupational Therapy
Evidence-Based Practice
Continuing Education
utilization
Guideline
Dementia
Guideline implementation

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014