Evaluation of Dutch Integrated Stroke Service Experiments

ISRCTN	ISRCTN67636203
DOI	https://doi.org/10.1186/ISRCTN67636203
Protocol serial number	N/A
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw)

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

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

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

Study information

Primary study design	Interventional
Study design	Prospective, non-randomized controlled trial.
Secondary study design	Non randomised controlled trial
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(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
Key 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.
Completion date	31/05/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	411
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes