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Table 2 Intervention studies meeting EPOC criteria for study design (n = 7)

From: How can we improve stroke thrombolysis rates? A review of health system factors and approaches associated with thrombolysis administration rates in acute stroke care

Citation, trial name, design, setting Target group, study duration Randomization methods Eligibility Sample size, response rate, representativeness Intervention conditions Outcome measures Statistical analysis Findings
Demaerschalk 2010 [38], USA
STRokE DOC AZ
RCT
Regional (spoke) and Academic Metropolitan (hub) hospitals
Hospital staff
Dec. 2007–Oct. 2008
Unit of analysis: patient
Concealed allocation: yes
Blinded: no
Allocation to condition: permuted block randomization of patients stratified by site
Patient: >18 years
tPA window: onset <3 h.
Patient: n = 54
Hospital: n = 3
Response rate, 68.4 %.
Representativeness: no demographic differences between groups
Myocardial infarction higher in int. group (p < 0.02).
Int-1: audio and video contact with a certified stroke team at a hub site, who had access to medical history, performed NIHSS, and reviewed test results and CT images
Int-2: a hub stroke consultant queried history, physical exam (including NIHSS), test results, CT report
tPA rate: denominator = acute stroke with <3 h onset.
Service delivery:
1. Evaluation times (e.g. door-ED)
2. Correct treatment decision
Patient outcomes:
1. Barthel Index (score 95–100)
2. mRS (score ≤2).
Cochran-Mantel-Haenszel test: comparison of correct decision rate between groups
Fisher’s exact test: rate of tPA, rate of intracranial haemorrhage, mortality, 90 day mRS
Wilcoxon rank sum test: 90-day Barthel Index and time comparisons
tPA rate: Int-1, 30 %; Int-2, 30 %
Service delivery:
1. NS
2. NS
Patient outcome:
1. NS
2. NS
Note: insufficient power to assess difference in tPA rates between groups.
Dirks, 2011 [41], The Netherlands.
PRACTISE
Cluster RCT
Hospitals
Hospital staff, including stroke neurologist and stroke nurse
May 2005–Jan. 2008
Unit of analysis: hospital
Concealed allocation: no
Blinded: no
Allocation to condition: hospitals randomised after pairwise matching on hospital type, tPA rate, stroke patients/year
Patient: >18 years
Hospital: 100–500 stroke admissions/year
tPA window: <4 h of onset
Patient: n = 1657.
Hospital: n = 12.
Response rate: Not reported.
Representativeness: patients: mean age, sex distribution and mean NIHSS at admission were similar between groups
Int: 5 × half day (across 2 years) meetings based on Breakthrough Series model. Teams of stroke neurologist and stroke nurse were created, who noted barriers to tPA use, set goals and plan actions
C: usual practices.
tPA rate: denominator = ischemic stroke, <4 h onset
Service delivery:
1. Onset-to-door time (min)
2. Door-to-needle time (min)
Patient outcome:
1. mRS <3 (at 3 months)
2. Quality of life—EuroQoL (at 3 months)
3. Mortality
Intention to treat
Multilevel logistic and linear regressions: comparison of tPA use, mRS, QoL and mortality between intervention groups.
Service delivery time analysis was adjusted for size, type and previous tPA rates, age, sex.
tPA rate: Int, 44 %; C, 39 % (unadjusted OR = 1.24 [1.02-1.51]).
Service delivery:
1. NS
2. NS
Patient outcome:
1. Poorer in C group
2. NS
3. NS
Meyer 2008 [39], USA
STRokE DOC
RCT
Remote “spoke” hospitals
Hospital staff
Jan. 2004–Aug. 2007
Unit of analysis: patient
Concealed allocation: no
Blinded: no
Allocation to condition: patients randomised within permuted blocks stratified by site
Patient: >18 years and ability to sign consent
tPA window: <3 h for treatment, but no time limit on eligibility for trial
Patient: n = 222 (111 vs 111)
Hospital: n = 4
Response rate: Patients: Not reported.
Representativeness: No demographic differences between groups. Int-1 had higher NIHSS score at presentation than Int-2 (p < 0.005).
Int-1: telemedicine (including video) consultation with patient by hub consultant including CT imaging
Int-2: telephone consultations for spoke sites with hub consultants
Hub provided treatment recommendations for both groups
tPA rate: denominator = acute stroke.
Service delivery:
1. Correct treatment decisions
2. Stroke onset to each point of care pathway (min)
Patient outcome:
1. Barthel Index (score 95–100).
2. mRS (score ≤2).
Fisher’s exact test: difference in tPA rate, functional outcomes tPA rate: Int-1, 28 %; Int-2, 23 % (OR = 1.3 [0.7–2.5], p = NS).
Service delivery:
1. Greater in Int-1 compared to Int-2 (98 vs 82 %, OR = 10.9 [2.7–44.6], p < 0.001).
2. Few differences in service delivery times.
Patient outcome:
1. No difference between groups
2. No difference between groups
Morgenstern et al. 2003 [42], USA
TTL Temple Foundation Stroke Project
CBA
Hospitals in two communities
Community members and hospital staff
Feb. 1998–Sept. 2000
Unit of analysis: patient
Concealed allocation: no
Blinded: no
Allocation to condition: comparison community selected to match chosen intervention community
Patient: >21 years and county resident
tPA window:<3 h
Patient:
Phase 1: n = 277 (136 vs 141)
Phase 2: n = 499 (266 vs 233)
Phase 3: n = 150 (80 vs 70)
Hospital: n = 10
Response rate: Patients: N/A
Hospitals: not reported
Representativeness: hospital characteristics reported
Int: community mass media, hospital-based systems change via multi-disciplinary team development of ED protocols, problem solving, medical education, feedback.
C: not specified.
tPA rate: denominator = ischemic stroke
Service delivery:
1. Delay time to hospital
2. Staff-reported barriers to treatment
Patient outcome: none assessed
Fisher’s exact test: rate of tPA
ANOVA: delay in times
tPA rate: Int (phases 1–3): 2.2, 8.6, 11.2 % (p < 0.007); C (phases 1–3): 0.7, 0.9 %, (p = NS)
Service delivery:
1. No difference in either group
2. Reduction for Int group only (no statistical test)
Schwamm et al. 2009 [32], USA
ITS
Academic and community hospitals
Hospitals
April 2003-July 2007
Unit of analysis: hospital
Concealed allocation: N/A
Blinded: N/A
Allocation to condition: N/A (ITS design)
Patient: Principal diagnosis of stroke or TIA, arrival <2 h from onset, ICD-9. Retrospective chart review to confirm stroke/TIA
Hospital: >30 patients
Patient: n = 322,847 (ischemic = 73.2 %; TIA = 26.8 %)
Hospital: n = 790
Response rate: Unclear. Staggered recruitment over 4 years. By Jan. 2007, 8.35 % hospitals had dropped out (n = 66)
Representativeness: hospital characteristics provided
Int: quality improvement (Get With The Guidelines [GWTG]) programme, with organisational meetings, tool kits, collaborative workshops, hospital recognition, decision support information, performance feedback. tPA rate: denominator = stroke or TIA, and arrival <2 h of onset
Service delivery: none assessed
Patient outcome:
1. Symptomatic intracranial haemorrhage within 36 h of tPA
Cochran-Mantel-Haenszel test: mean score for changes in rate of tPA and intracranial haemorrhage over time tPA rate: significant increase from baseline (42.1 %) to year 5 (72.8 %; p < 0.0001).
Patient outcome:
1. NS over time
Greatest improvement (composite performance/program year in GWTG) in hospitals with more beds (p < 0.0001), larger annual stroke volume (p < 0.0001) and teaching status (p < 0.0001)
Scott et al. 2013 [43], USA
INSTINCT
Cluster RCT
Community hospitals
Physicians, pharmacists, nurses, EMS, admin teams
Jan.–Dec. 2007
Unit of analysis: hospital
Concealed allocation: no
Blinded: no
Allocation to condition: within pairs, hospitals were randomised to intervention or control groups. Randomisation reversed for three pairs to achieve greater urban/rural balance
Hospitals: discharging ≥100 stroke patient/year, <100 000 ED visits/year and non-academic stroke centres
tPA window: not specified
Hospitals: n = 24
Response rate: 83 %
Representativeness: not reported
Int: clinical practice guideline promotion, development of local stroke champions, continuing education, telephone support for treatment decision, academic detailing, audit and feedback
C: usual practices
tPA rate: denominator = ischemic stroke
Service delivery:
1. Adherence to tPA guidelines
Patient outcome:
1. Safety data from proportion of patients (2.2 %), with reported haemorrhage
Intention-to-treat (ITT) and target population (without one pair that was excluded after randomisation)
Generalised linear mixed model: assumed intra-hospital correlation between tPA rates at pre- and post- intervention periods
tPA rate: ITT: Int (pre and post), 1.25 and 2.79 %; C (n = 1; pre and post), 1.25 and 2.10 %. Int vs C, p = NS.
Target analysis: Int (pre and post), 1.0 and 2.62 %; C (pre and post),1.09 and 1.72 %. Int vs C, RR = 1.68 [1.09–2.57], p = 0.02
Service delivery:
1. NS difference between groups
Patient outcome:
1. NS difference between groups
Theiss et al. 2013 [40], Germany
CBA
Comprehensive stroke centres, and primary care hospitals
Hospitals
2006–2009
Unit of analysis: hospital
Concealed allocation: no
Blinded: not reported
Allocation to condition: hospitals matched on beds, distance from closest hub site and departments of internal medicine
Hospitals: not reported
No study hospitals had specialised stroke care prior to study start
Hospitals: n = 15
Response rate: not reported.
Representativeness: not reported
Int: tele-consultation service. Consisted of hub (n = 5) and spoke (n = 5) sites
C: usual practices
tPA rate denominator: all stroke
Service delivery: none assessed
Patient outcome:
1. Intracerebral haemorrhage
2. Mortality
Mean and SEM: for descriptive data
Student t and Fisher exact tests: longitudinal and pairwise comparisons, pooled ischemic stroke mortality
tPA rate: Hub sites: (pooled) increased 4.2 to 7.7 % (p < 0.0001); Spoke sites: (pooled) increased 1.1 to 5.9 % (p < 0.0001); C: (one hospital only) increased 0.8 to 5.7 % (p = 0 . 03).
Patient outcome:
1. NS
2. Significant decreases in spoke site only (10.3 to 7.3 %, p = 0.03)
  1. Abbreviations: C control group, CBA controlled before and after trial, CT computer tomography, ED emergency department, EMS emergency medical service, RCT randomised controlled trial, Int intervention group, ITS interrupted time series, mRS modified Rankin score, NIHSS National institute of Health Stroke Scale, TIA transient ischemic attack, tPA tissue plasminogen activator, QoL quality of life, N/A not applicable