Intervention to Bridge the Evidence-based Gap in Stroke Care Quality

NCT02212912 | Completed DMC

• 1 other identifier: aic2014
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether a multifaceted quality improvement intervention can improve the adherent rate of individual and composite of evidence-based performance measures for patients with acute ischemic stroke within the first 7 days of symptom onset and reduce the incidence of a new clinical vascular event, disability, and all-cause mortality at discharge and long term clinical outcome.

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke, performance measure, acute treatment

Outcome Measures

Primary Outcomes (2)

• percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications

  The primary end point was all-or-none measure of evidence-based performance measures in patients without contraindications, at the emergency department (Intravenous tissue-type plasminogen activator (tPA) in patients who arrive within 2 hours after initial symptom onset and treated within 3 hours), during 48 hours after admission (antithrombotic drugs; dysphagia screening; deep venous thrombosis prophylaxis including pneumatic compression devices, subcutaneous unfractionated heparin, low molecular weight heparin, or full-dose anticoagulation (e.g., with heparin or warfarin)) , and at discharge (antithrombotic therapy, discharge on anticoagulation for patients with atrial fibrillation, and discharged on statin, antihypertensive, and hypoglycemic medications). An all-or-none measure of care was used, which is defined as the proportion of patients who received all of the performance measure interventions for which they were eligible.

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• a composite measure score of performance measures

  a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (1)

• percentage of new clinical vascular event (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) , disability (disability defined as Modified Rankin Score (mRS) ≥ 2) , and all-cause mortality

  3,6,12 months

Other Outcomes (1)

• a composite measure score of performance measures

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Improvement intervention

OTHER

Improvement intervention is a multifaceted quality improvement method including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures.

Behavioral: improvement intervention

no intervention

OTHER

The control group indicated that the physicians will not be provided with the information of multifacet improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care

Behavioral: no intervention

Interventions

improvement intervention BEHAVIORAL

Evidence-based clinical pathway: It contained general guideline-based recommendations about acute stroke management. Standard operating procedures (SOP) of performance indicators. A quality coordinator:The role of the quality coordinator includes interacting with physicians once gaps in the incorporation of evidence-based interventions are identified, ensuring that all components of the quality improvement intervention are being used for every acute ischemic stroke (AIS) patient.Monitoring and feedback system of performance measures. The system could view the level of implementation of prespecified performance measures at any time (per week recommended) , compare with the previous record of own study site and level of other clusters.

Improvement intervention

no intervention BEHAVIORAL

No intervention indicated that the physicians among control hospital provide routine

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18
• Ischemic stroke within 7 days of the index event
• Direct admission based on physician evaluation or arrival through the emergency department
• Ability of patient or legally authorized representative to provide informed consent for 3, 6,and 12 months after initial symptom onset
• Eligible events were confirmed by brain ct or mri within7 days after the onset of symptoms

You may not qualify if:

• Patients refuse to participate in this study

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (3)

• Lynch EA, Bulto LN, Cheng H, Craig L, Luker JA, Bagot KL, Thayabaranathan T, Janssen H, McInnes E, Middleton S, Cadilhac DA. Interventions for the uptake of evidence-based recommendations in acute stroke settings. Cochrane Database Syst Rev. 2023 Aug 11;8(8):CD012520. doi: 10.1002/14651858.CD012520.pub2.

  PMID: 37565934 DERIVED

• Wang Y, Li Z, Zhao X, Wang C, Wang X, Wang D, Liang L, Liu L, Wang C, Li H, Shen H, Bettger J, Pan Y, Jiang Y, Yang X, Zhang C, Han X, Meng X, Yang X, Kang H, Yuan W, Fonarow GC, Peterson ED, Schwamm LH, Xian Y, Wang Y; GOLDEN BRIDGE-AIS Investigators. Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial. JAMA. 2018 Jul 17;320(3):245-254. doi: 10.1001/jama.2018.8802.

  PMID: 29959443 DERIVED

• Wang Y, Li Z, Xian Y, Zhao X, Li H, Shen H, Wang C, Liu L, Wang C, Pan Y, Wang D, Prvu Bettger J, Fonarow GC, Schwamm LH, Smith SC Jr, Peterson ED, Wang Y; GOLDEN BRIDGE-AIS investigators. Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke. Am Heart J. 2015 Jun;169(6):767-774.e2. doi: 10.1016/j.ahj.2015.03.008. Epub 2015 Mar 26.

  PMID: 26027613 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yilong Wang, M.D

  Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

• Yongjun Wang, M.D

  Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: August 2, 2014
• First Posted: August 8, 2014
• Study Start: August 10, 2014
• Primary Completion: June 20, 2015
• Study Completion: July 30, 2016
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

CN (1)