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

Study website

Contact information

Prof Robbert Huijsman
Scientific

Inst Health Policy & Managment
Erasmus Unversity Rotterdam
Burgemeester Oudlaan 50
Rotterdam
3000DR
Netherlands

Phone +31 10 4088555
Email r.huijsman@erasmusmc.nl

Study information

Study designProspective, non-randomized controlled trial.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymEDISSE
Study objectivesStroke 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) studiedIschemic stroke
InterventionThe “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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/09/1999
Completion date31/05/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participantsA minimum of 75 and a maximum of 100 patients per cluster; 411 patients were registered.
Key inclusion criteriaAll 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 criteriaDead on arrival.
Date of first enrolment01/09/1999
Date of final enrolment31/05/2000

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Inst Health Policy & Managment
Rotterdam
3000DR
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw)
Research organisation

Laan van Nieuw Oost Indië 334
Postbox 93 245
The Hague
2509 AE
Netherlands

Website http://www.zonmw.nl/en/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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