Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Robbert Huijsman


Contact details

Inst Health Policy & Managment
Erasmus Unversity Rotterdam
Burgemeester Oudlaan 50
+31 10 4088555

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

Stroke services lead to better and more effective, efficient and patient-directed care for stroke patients compared to usual care.

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.

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Ischemic stroke


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



Not Specified

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant 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.

Participant type


Age group

Not Specified



Target number of participants

A minimum of 75 and a maximum of 100 patients per cluster; 411 patients were registered.

Participant exclusion criteria

Dead on arrival.

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Inst Health Policy & Managment

Sponsor information


The Netherlands Organisation for Health Research and Development (ZonMw)

Sponsor details

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

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Results:
2. Results:
3. Results:
4. Results:
5. Results:
6. Results:

Publication citations

  1. Results

    van Exel NJ, Koopmanschap MA, Scholte op Reimer W, Niessen LW, Huijsman R, Cost-effectiveness of integrated stroke services., QJM, 2005, 98, 6, 415-425, doi: 10.1093/qjmed/hci065.

  2. Results

    van Exel NJ, Koopmanschap MA, van den Berg B, Brouwer WB, van den Bos GA, Burden of informal caregiving for stroke patients. Identification of caregivers at risk of adverse health effects., Cerebrovasc. Dis., 2005, 19, 1, 11-17, doi: 10.1159/000081906.

  3. Results

    van Exel NJ, Brouwer WB, van den Berg B, Koopmanschap MA, van den Bos GA, What really matters: an inquiry into the relative importance of dimensions of informal caregiver burden., Clin Rehabil, 2004, 18, 6, 683-693.

  4. Results

    van Exel NJ, Scholte op Reimer WJ, Koopmanschap MA, Assessment of post-stroke quality of life in cost-effectiveness studies: the usefulness of the Barthel Index and the EuroQoL-5D., Qual Life Res, 2004, 13, 2, 427-433.

  5. Results

    van Exel NJ, Scholte op Reimer WJ, Brouwer WB, van den Berg B, Koopmanschap MA, van den Bos GA, Instruments for assessing the burden of informal caregiving for stroke patients in clinical practice: a comparison of CSI, CRA, SCQ and self-rated burden., Clin Rehabil, 2004, 18, 2, 203-214.

  6. Results

    Van Exel J, Koopmanschap MA, Van Wijngaarden JD, Scholte Op Reimer WJ, Costs of stroke and stroke services: Determinants of patient costs and a comparison of costs of regular care and care organised in stroke services., Cost Eff Resour Alloc, 2003, 1, 1, 2.

Additional files

Editorial Notes