Implementation and Evaluation of the COTiD Program in the Netherlands

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

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.

Study Overview

• Status: Unknown
• Conditions: Dementia
• Intervention / Treatment: Other: 3-day post-graduate course; Other: Combined implementation strategy

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: implementation training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development
• Collaborators: HAN University of Applied Sciences
• Investigators: Study Chair: Myrra Vernooij-Dassen, PhD, Radboud University Medical Center; Principal Investigator: Maud Graff, PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Estimate): May 21, 2010
• Last Update Submitted That Met QC Criteria: May 20, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Dementia; Occupational Therapy; Guideline; Evidence-Based Practice; utilization; Continuing Education; Guideline implementation
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 80-82315-98-090010