Clinical trial NCT01117285: Implementation and Evaluation of the COTiD Program in the Netherlands
Official title: Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Occupational Therapy
Evidence-Based Practice
Continuing Education
utilization
Guideline
Dementia
Guideline implementation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: HAN University of Applied Sciences
First posted: 2010-05-05
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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).

Primary outcomes:
measure: Adherence of occupational therapists to the COTiD program
timeFrame: one year (baseline, T1, and T2)
measure: Community occupational therapy use according to the COTiD program
timeFrame: one year
measure: Costs of the implementation strategies
timeFrame: October 2009 - December 2011
Secondary outcomes:
measure: Knowledge of the healthcare professionals about the COTiD program
timeFrame: one year (baseline, T1, and T2)
measure: COTiD program treatment outcome on client and caregiver level
timeFrame: one year (baseline, T1, and T2)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Myrra Vernooij-Dassen, PhD
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: Maud Graff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/bmj.39001.688843.BE. Epub 2006 Nov 17.
citation: 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.
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.
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. doi: 10.1093/gerona/62.9.1002.
citation: 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.
citation: 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.
citation: 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.