Contact information
Type
Scientific
Primary contact
Prof Robbert Huijsman
ORCID ID
Contact details
Inst Health Policy & Managment
Erasmus Unversity Rotterdam
Burgemeester Oudlaan 50
Rotterdam
3000DR
Netherlands
+31 10 4088555
r.huijsman@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EDISSE
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
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
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
01/09/1999
Overall trial end date
31/05/2000
Reason abandoned
Eligibility
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
Patient
Age group
Not Specified
Gender
Both
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
01/09/1999
Recruitment end date
31/05/2000
Locations
Countries of recruitment
Netherlands
Trial participating centre
Inst Health Policy & Managment
Rotterdam
3000DR
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw)
Sponsor details
Laan van Nieuw Oost Indië 334
Postbox 93 245
The Hague
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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: 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
Publication citations
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.