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| [ ...Back to search results ] | [ Print-friendly version ] |
| Evaluation of Dutch Integrated Stroke Service Experiments |
| ISRCTN | ISRCTN67636203 |
| ClinicalTrials.gov identifier | |
| Public title | Evaluation of Dutch Integrated Stroke Service Experiments |
| Scientific title | |
| Acronym | EDISSE |
| Serial number at source | N/A |
| Study hypothesis | Stroke services lead to better and more effective, efficient and patient-directed care for stroke patients compared to usual care. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Approvals received from Local Medical Ethics Committees for all six regional services at all hospitals involved between May and September 1999.
Case regions: 1. Heemstede, Spaarne Hospital: Medical Ethics Committee of Spaarne Hospital 2. Delft, Hospital Reinier de Graaf Groep: Medical Ethics Committee for South West Holland 3. Nijmegen, Canisius Wilhelmina Hospital: Ethics Committee of Canisius Control regions: 1. Amsterdam, Saint Lucas Andreas Hospital: Medical Ethics Committee of Saint Lucas Andreas Hospital 2. Hilversum, Hilversum Hospital: Medical Ethics Committee of Hilversum Hospital 3. Leiderdorp, Rijnland Hospital: Medical Ethics Committee of Rijnland Hospital Central registration: 1. Central Committee for Patient-Related Research: annual reports and overviews of decisions by local MECs 2. The Central Committee on Research Involving Human Subjects (CCMO) |
| Study design | Prospective, non-randomized controlled trial. |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Ischemic stroke |
| Participants - inclusion criteria |
All patients in these experimental settings were compared to similar concurrent patients from general hospitals in three other Dutch regions. The latter were selected from a group of 23 hospitals participating in a previous national study. Based on the data collected in this already completed study, three hospitals were selected as representing the average Dutch patient, receiving the average current level of Dutch stroke care. The criteria for this selection were:
1. The average age of patients 2. Duration of hospital stay 3. Case-fatality 4. Barthel Index at discharge 5. Destination after discharge All consecutive hospital patients admitted in a region with an acute first or recurrent ischemic stroke or Transient Ischemic Attack (TIA) were included. |
| Participants - exclusion criteria | Dead on arrival. |
| Anticipated start date | 01/09/1999 |
| Anticipated end date | 31/05/2000 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | A minimum of 75 and a maximum of 100 patients per cluster; 411 patients were registered. |
| Interventions |
The “experimental” stroke service settings were those that provided “Integrated Stroke unit and Stroke services care” as defined by an expert consensus committee. Methodologically, the assessment of integrated stroke services is the evaluation of a complex mixture of interventions at the organizational, professional and patient levels. It needs careful definition, or at least a full description to allow for a transparent (cost-) effectiveness analysis. Formally, Dutch stroke services are defined as a network of service providers working together in an organized way to proved adequate services in all stages of the follow-up of stroke patients. It includes a hospital stroke unit. An expert group made this broad definition more explicit, defining a core set and an optimal set of criteria. It emphasizes a setting integrating all relevant institutions: hospitals, nursing homes, rehabilitation centers, general practitioners and home care providers working together to provide multidisciplinary, coordinated care through organized patient transfers and protocols. This definition is in accordance with international views.
We compared all consecutively hospitalized stroke patients in three experimental stroke service settings (Delft, Haarlem and Nijmegen, 411 patients in total) with concurrent patients receiving conventional stroke care (187 patients) over 6 months follow-up. |
| Primary outcome measure(s) |
1. Health-related quality-of-life (QALIES) at two and six months
2. Cumulative total societal costs at three months (direct and indirect costs) 3. "Length-of-stay" as the most important cost driver |
| Secondary outcome measure(s) |
1. Other neurological health outcomes (Glasgow Coma Scale, 30 item version of the Sickness Impact Profile [SA-SIP30], Cambridge Cognitive Examination, modified Rankin Scale [mRS], The Barthel Index [BI])
2. Care satisfaction 3. Indirect medical costs 4. Residence 5. Quality of care A qualitative study also observed the characteristics of the regional services. |
| Sources of funding | The Netherlands Organisation for Health Research and Development (ZonMw) |
| Trial website | http://www.zonmw.nl |
| Publications |
1. Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15879443
2. Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15528879 3. Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15473120 4. Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15085915 5. Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15053130 6. Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12773219 |
| Contact name | Prof Robbert Huijsman |
| Address |
Inst Health Policy & Managment
Erasmus Unversity Rotterdam Burgemeester Oudlaan 50 |
| City/town | Rotterdam |
| Zip/Postcode | 3000DR |
| Country | Netherlands |
| Tel | +31 10 4088555 |
| Fax | +31 10 4089093 |
| r.huijsman@erasmusmc.nl | |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) |
| Address |
Laan van Nieuw Oost Indië 334
Postbox 93 245 |
| City/town | The Hague |
| Zip/Postcode | 2509 AE |
| Country | Netherlands |
| Sponsor website: | http://www.zonmw.nl/en/ |
| Date applied | 26/06/2007 |
| Last edited | 30/08/2011 |
| Date ISRCTN assigned | 26/07/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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