A cluster-randomized trial to improve stroke care in hospitals
Open accessAbstract
OBJECTIVE: We evaluated the effect of performance feedback on acute ischemic stroke care quality in Minnesota hospitals. METHODS: A cluster-randomized controlled trial design with hospital as the unit of randomization was used. Care quality was defined as adherence to 10 performance measures grouped into acute, in-hospital, and discharge care. Following preintervention data collection, all hospitals received a report on baseline care quality. Additionally, in experimental hospitals, clinical opinion leaders delivered customized feedback to care providers and study personnel worked with hospital administrators to implement changes targeting identified barriers to stroke care. Multilevel models examined experimental vs control, preintervention and postintervention performance changes and secular trends in performance. RESULTS: Nineteen hospitals were randomized with a total of 1,211 acute ischemic stroke cases preintervention and 1,094 cases postintervention. Secular trends were significant with improvement in both experimental and control hospitals for acute (odds ratio = 2.7, p = 0.007) and in-hospital (odds ratio = 1.5, p < 0.0001) care but not discharge care. There was no significant intervention effect for acute, in-hospital, or discharge care. CONCLUSION: There was no definite intervention effect: both experimental and control hospitals showed significant secular trends with performance improvement. Our results illustrate the potential fallacy of using historical controls for evaluating quality improvement interventions. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that informing hospital leaders of compliance with ischemic stroke quality indicators followed by a structured quality improvement intervention did not significantly improve compliance more than informing hospital leaders of compliance with stroke quality indicators without a quality improvement intervention.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In Lakshminarayan 2010, overall risk of bias was unclear.
“Risk of bias overall Unclear risk 4 unclear risk criteria”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, contamination was at low risk of bias.
“Contamination Low risk Hospitals randomised”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, baseline characteristics were at low risk of bias.
“Baseline characteristics Low risk Patient characteristics were similar”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, random sequence generation was at unclear risk of bias.
“Random sequence generation (selection bias) Unclear risk A randomised block design was used, but the method for generating the randomisation sequence was not described”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, other bias was at low risk of bias.
“Other bias Low risk Low likelihood of contamination; baseline characteristics of patients similar”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, incomplete outcome data was at low risk of bias.
“Incomplete outcome data (attrition bias) All outcomes Low risk No loss to follow‐up after randomisation”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, selective reporting was at low risk of bias.
“Selective reporting (reporting bias) Low risk Appropriate outcomes reported”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
In Lakshminarayan 2010, baseline outcomes were at unclear risk of bias.
“Baseline outcomes Unclear risk The baseline outcomes were similar, except for onset to drug treatment within 180 minutes; not clear if this was adjusted for”
From Tailored interventions to address determinants of practice (2015) · cites this paper as Lakshminarayan 2010
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Tissue Plasminogen Activator for Acute Ischemic Stroke
(1995) · New England Journal of Medicine · doi:10.1056/nejm199512143332401 · Cited by 11,654 · see citing works
Altman, R., Carreras, L., Díaz, R. S., Figueroa, E. B., Paolasso, E., Parodi, J. C., Cade, J. F., Donnan, G. A., Eadie, M. J., Gavaghan, T. P., et al. (1994) · BMJ · doi:10.1136/bmj.308.6921.81 · Cited by 4,198 · see citing works
Altman, R., Carreras, L., Díaz, R. S., Figueroa, E. B., Paolasso, E., Parodi, J. C., Cade, J. F., Donnan, G. A., Eadie, M. J., Gavaghan, T. P., et al. (1994) · Cited by 3,322 · see citing works
Guidelines for the Early Management of Adults With Ischemic Stroke
Adams, H. P., del Zoppo, G., Alberts, M. J., Bhatt, D. L., Brass, L. M., Furlan, A. J., Grubb, R. L., Higashida, R. T., Jauch, E. C., Kidwell, C. S., et al. (2007) · Stroke · doi:10.1161/strokeaha.107.181486 · Cited by 2,461 · see citing works
Sacco, R. L., Adams, R., Albers, G., Alberts, M. J., Benavente, O., Furie, K., Goldstein, L. B., Gorelick, P., Halperin, J., Harbaugh, R., et al. (2006) · Stroke · doi:10.1161/01.str.0000199147.30016.74 · Cited by 1,873 · see citing works
Chen, Z.-M. (1997) · The Lancet · doi:10.1016/s0140-6736(97)04010-5 · Cited by 1,226 · see citing works
Local opinion leaders: effects on professional practice and health care outcomes
Flodgren, G., Parmelli, E., Doumit, G., Gattellari, M., O'Brien, M. A., Grimshaw, J., & Eccles, M. P. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000125.pub4 · Cited by 1,070 · see citing works
Changing Physicians' Practices
Greco, P. J., & Eisenberg, J. M. (1993) · New England Journal of Medicine · doi:10.1056/nejm199310213291714 · Cited by 976 · see citing works
Berwick, D. M. (2008) · JAMA · doi:10.1001/jama.299.10.1182 · Cited by 809 · see citing works
(1994) · Europe PMC (PubMed Central) · Cited by 755 · see citing works
Recommendations for the Establishment of Primary Stroke Centers
Alberts, M. J. (2000) · JAMA · doi:10.1001/jama.283.23.3102 · Cited by 725 · see citing works
Evidence-Based Quality Improvement: The State Of The Science
Shojania, K. G., & Grimshaw, J. (2005) · Health Affairs · doi:10.1377/hlthaff.24.1.138 · Cited by 688 · see citing works
Patterns of intra-cluster correlation from primary care research to inform study design and analysis
Adams, G., Gulliford, M. C., Ukoumunne, O. C., Eldridge, S., Chinn, S., & Campbell, M. J. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2003.12.013 · Cited by 602 · see citing works
Schwamm, L. H., Fonarow, G. C., Reeves, M. J., Pan, W., Frankel, M., Smith, E. E., Ellrodt, G. A., Cannon, C. P., Liang, L., Peterson, E. D., et al. (2008) · Circulation · doi:10.1161/circulationaha.108.783688 · Cited by 567 · see citing works
Soumerai, S. B., McLaughlin, T. J., Gurwitz, J. H., Guadagnoli, E., Hauptman, P. J., Borbas, C., Morris, N., McLaughlin, B., Gao, X., Willison, D. J., et al. (1998) · JAMA · doi:10.1001/jama.279.17.1358 · Cited by 479 · see citing works
Self-citationThe Paul Coverdell Prototype Registries Writing Group* (2005) · Stroke · doi:10.1161/01.str.0000165902.18021.5b · Cited by 406 · see citing works
National US Estimates of Recombinant Tissue Plasminogen Activator Use
Kleindorfer, D., Lindsell, C. J., Brass, L. M., Koroshetz, W. J., & Broderick, J. P. (2008) · Stroke · doi:10.1161/strokeaha.107.490375 · Cited by 273 · see citing works
Zimmerman, J. E., Shortell, S. M., Rousseau, D. M., Duffy, J. R., Gillies, R. R., Knaus, W. A., Devers, K. J., Wagner, D. P., & Draper, E. A. (1993) · Critical Care Medicine · doi:10.1097/00003246-199310000-00010 · Cited by 256 · see citing works
Atrial Fibrillation and Stroke in the General Medicare Population
Lakshminarayan, K., Solid, C. A., Collins, A. J., Anderson, D. C., & Herzog, C. A. (2006) · Stroke · doi:10.1161/01.str.0000230607.07928.17 · Cited by 242 · see citing works
Self-citationSustained Benefit of a Community and Professional Intervention to Increase Acute Stroke Therapy
Morgenstern, L. B., Bartholomew, L. K., Grotta, J. C., Savas, L. S., King, M., & Chan, W. (2003) · Archives of Internal Medicine · doi:10.1001/archinte.163.18.2198 · Cited by 143 · see citing works
Holloway, R. G., Benesch, C. G., & Rush, S. R. (2000) · Neurology · doi:10.1212/wnl.54.10.1899 · Cited by 114 · see citing works
Development of Complex Interventions in Stroke Care
Redfern, J., McKevitt, C., & Wolfe, C. D. A. (2006) · Stroke · doi:10.1161/01.str.0000237097.00342.a9 · Cited by 100 · see citing works
Extending the CONSORT statement to cluster randomized trials: for discussion
Elbourne, D. R., & Campbell, M. (2001) · Statistics in Medicine · doi:10.1002/1097-0258(20010215)20:3 · Cited by 91 · see citing works
Development of Performance Measures for Acute Ischemic Stroke
Holloway, R. G., Vickrey, B. G., Benesch, C. G., et al. (2001) · Stroke · doi:10.1161/hs0901.94620 · Cited by 80 · see citing works
Blood Pressure Exceeding National Guidelines Among Women After Stroke
Kernan, W. N., Viscoli, C. M., Brass, L. M., et al. (2000) · Stroke · doi:10.1161/01.str.31.2.415 · Cited by 36 · see citing works
Flagged first, then by citations
Research works printed but not linked: 7
- Zimmerman JE, Shortell SM, Rousseau DM, et al. Im- proving intensive care: observations based on organiza- tional case studies in nine intensive care units: a prospective, multicenter study. Crit Care Med 1993;21: 1443-1451.
- Borbas C, McLaughlin DB, Schultz A. The Minnesota Clinical Comparison and Assessment Program: bridging the gap between clinical practice guidelines and patient care. In: Zablocki E, ed. Changing Physician Practice Pat- terns: Strategies for Success in a Capitated World. Gaith- ersburg, MD: Aspen Publishers Inc.; 1995:29.
- Hiss RG, MacDonald R, David WR. Identification of physician educational influentials in small community hospitals. Res Med Educ 1978;17:283-288.
- Ukoumunne OC, Thompson SG. Analysis of cluster ran- domized trials with repeated cross-sectional binary mea- surements. Stat Med 2001;20:417-433.
- Murray DM. Design and Analysis of Group-Randomized Trials. New York: Oxford University Press; 1998.
- Alberts MJ, Hademenos G, Latchaw RE, et al. Recom- mendations for the establishment of primary stroke cen- ters: Brain Attack Coalition. JAMA 2000;283:3102-3109.
- Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications Ltd.; 1997.
Cited by
Sorted by citations
Audit and feedback: effects on professional practice and healthcare outcomes
Ivers, N., Jamtvedt, G., Flottorp, S., Young, J. M., Odgaard-Jensen, J., French, S. D., O'Brien, M. A., Johansen, M., Grimshaw, J., & Oxman, A. D. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000259.pub3 · Cited by 5,485 · see citing works
Local opinion leaders: effects on professional practice and health care outcomes
Flodgren, G., Parmelli, E., Doumit, G., Gattellari, M., O'Brien, M. A., Grimshaw, J., & Eccles, M. P. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000125.pub4 · Cited by 1,070 · see citing works
Tailored interventions to address determinants of practice
Baker, R., Camosso-Stefinovic, J., Gillies, C., Shaw, E. J., Cheater, F., Flottorp, S., Robertson, N., Wensing, M., Fiander, M., Eccles, M. P., et al. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005470.pub3 · Cited by 711 · see citing works
- Authors
- Lakshminarayan, K., Borbas, C., McLaughlin, B., Morris, N. E., Vazquez, G., Luepker, R. V., & Anderson, D. C.
- Affiliations
- University of Minnesota (US)
- Venue
- Neurology
- Published
- 2010-05-18
- Volume
- 74
- Issue
- 20
- Pages
- 1634-1642
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC2875128
- OpenAlex
- W2002421485
- Cited by
- 38
- References
- 31
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 4 · 2023: 5 · 2022: 1 · 2020: 1 · 2019: 3 · 2018: 2 · 2017: 2 · 2016: 1 · 2015: 3 · 2014: 1 · 2013: 4 · 2012: 3
- FWCI
- 5.96
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Heart Association
- American Academy of Neurology
- Northwestern University
- Harvard University
- University of Minnesota
- Hennepin County Medical Center
- Minneapolis Medical Research Foundation
- Lunds Universitet
- Hyderabad Eye Research Foundation
- National Institutes of Health (NHLBI R01)
- Centers for Disease Control and Prevention
- Agency for Healthcare Research and Quality (U18HS11073)
- National Heart, Lung, and Blood Institute
- National Institute of Neurological Disorders and Stroke (K23NS051377)
- National Center for Research Resources
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Quality and Management
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- acute ischemic stroke, stroke care quality, performance feedback, quality improvement intervention, hospital quality indicators, historical controls, secular trends, discharge care, inpatient care
- MeSH terms
- Hospitals, Humans, Quality of Health Care, United States, Chi-Square Distribution, Odds Ratio, Total Quality Management, Health Care Surveys, Guideline Adherence, Stroke, Intention to Treat Analysis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
