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| Name | Class |
|---|---|
| HAN University of Applied Sciences | OTHER |
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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.
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:
In addition the effect of the implementation strategies on patient and caregiver outcomes will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-day post-graduate course | Active Comparator | 3-day post-graduate course on the use of the COTiD program in clinical practice |
|
| Combined implementation strategy | Experimental | The combined implementation strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-day post-graduate course | Other | 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. |
| 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:
| one year |
| Costs of the implementation strategies | The following cost data is collected: Costs of the implementation strategies
Costs made buy the cliënt and caregiver
| October 2009 - December 2011 |
| 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 |
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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:
Exclusion Criteria:
Criteria for client with dementia and their informal caregiver
Inclusion Criteria for clients and informal caregivers:
Exclusion criteria for clients:
Exclusion criteria for informal caregivers:
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| Name | Affiliation | Role |
|---|---|---|
| Myrra Vernooij-Dassen, PhD | Radboud University Medical Center | Study Chair |
| Maud Graff, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation) | Nijmegen | Gelderland | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17114212 | Background | 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. | |
| 18171718 | Background | 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. |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
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| Combined implementation strategy | Other | The combined implementation strategy provides strategies for occupational therapists (OTs), physicians, and managers. OTs receive:
Managers and physicians receive:
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The following outcomes are evaluated:
|
| one year (baseline, T1, and T2) |
| 19799779 | Background | 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. |
| 17895439 | Background | 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. |
| 25547113 | Derived | 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. |
| 23718565 | Derived | 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. |
| 21450063 | Derived | 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. |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |