Evaluation of Dutch Integrated Stroke Service Experiments
| ISRCTN | ISRCTN67636203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67636203 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/06/2007
- Registration date
- 26/07/2007
- Last edited
- 30/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robbert Huijsman
Scientific
Scientific
Inst Health Policy & Managment
Erasmus Unversity Rotterdam
Burgemeester Oudlaan 50
Rotterdam
3000DR
Netherlands
| Phone | +31 10 4088555 |
|---|---|
| r.huijsman@erasmusmc.nl |
Study information
| Study design | Prospective, non-randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | EDISSE |
| Study objectives | Stroke services lead to better and more effective, efficient and patient-directed care for stroke patients compared to usual care. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | Ischemic stroke |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/09/1999 |
| Completion date | 31/05/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | A minimum of 75 and a maximum of 100 patients per cluster; 411 patients were registered. |
| Key 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. |
| Key exclusion criteria | Dead on arrival. |
| Date of first enrolment | 01/09/1999 |
| Date of final enrolment | 31/05/2000 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Inst Health Policy & Managment
Rotterdam
3000DR
Netherlands
3000DR
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
Postbox 93 245
The Hague
2509 AE
Netherlands
| Website | http://www.zonmw.nl/en/ |
|---|---|
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results: | 26/02/2003 | Yes | No | |
| Results article | Results: | 01/03/2004 | Yes | No | |
| Results article | Results: | 01/03/2004 | Yes | No | |
| Results article | Results: | 01/09/2004 | Yes | No | |
| Results article | Results: | 03/11/2004 | Yes | No | |
| Results article | Results: | 01/06/2005 | Yes | No |
