Implementing International Standards of Practice in A Low Resource Country by Blended Training Modules to Improve Stroke Care

Stroke Clinical Trial

Official title:

Implementing International Standards of Practice in A Low Resource Country by Blended Training Modules to Improve Stroke Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04995146
• Other study ID #: FUI/CTR/2020/8
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lack of proper stroke care delivery leads to poor patient outcomes in middle- and low-income countries that can be improved by implementation of international standards. We aim to determine feasibility of implementing stroke core measures and training through blended learning modules in resource poor countries to improve stroke outcomes.

Description:

Background: Lack of proper stroke care delivery leads to poor patient outcomes in middle- and low-income countries that can be improved by implementation of international standards. We aim to determine feasibility of implementing stroke core measures and training through blended learning modules in resource poor countries to improve stroke outcomes. Methods: The project will be conducted across four hospitals in Pakistan in three phases. First stage will include retrospective collection of data for the preceding 4 weeks from start. In stage II, 3 months data will be collected before implementation of core measures. The stepwise training of staff will begin simultaneously, and data will continue to be collected. In stage III by the end of 3 months of stage II, core measures will be implemented as standard of care and patients will be enrolled for another 3 months. Outcomes measures will be successful implementation of the stroke care model as measured by survey done at the end and patient outcomes including in-hospital complication rates, length of hospital stay, patient and caregiver education, mRS at 3 months after discharge, post discharge complications and re-stroke rate. Data will be compared against published data from Pakistan and between patients in the first and last 3 months of the project. Statistical analyses will include appropriate mixed-effects multivariate regression models (i.e., linear and logistic) to model the relationship between clinical measures and patient safety. Degree of correlation across each symptom predictor will be measured. This study will not involve thrombolytic therapy or thrombectomy. However, the study will not provide any hindrance to implementation of such therapy and will not include such patients in analysis. Discussion: At least one third of stroke survivors in Pakistan die due to recurrent vascular events and complications of stroke in absence of core measures. Prevention practices and stroke care are significantly underutilized in low- and middle-income countries but can be improved most efficiently by improving care delivering process without additional burden on resources by following American Heart Association "Get With The Guidelines" Stroke (GWTG-Stroke) program, Royal College of Physicians UK and European Guidelines, regardless of thrombolysis or thrombectomy. This feasibility study aims to develop a multidisciplinary comprehensive stroke team model with gradual integration of staff training, nursing care, therapy and patient education.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Acute onset of Symptoms in the last 24 hours suggestive of stroke Age > 18 years Ischemic or hemorrhagic stroke - Exclusion Criteria: Presenting after 24 hours of onset of symptoms Alternate explanation for presenting symptoms (stroke mimics) Family (Surrogate Decision Maker) or next of kin/ patient refusal for participation Transfer of care from another department or hospital Care needed in another department (e.g, ICU, other department) GCS (Glasgow Coma Scale) below 5 or End of life care initiated TIA (Transient Ischemic Attack) -

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Clinical stroke extended management pathway
Extracranial imaging ECG in 2-7 days DVT prophylaxis Stroke educational material for patient and family Removal of Foley's catheter and start bladder management Discharged on: Antithrombotic therapy OR Anticoagulation therapy? Antihypertensives ? Statins/cholesterol lower agent ? Antidiabetic agent Fasting lipid profile, HbA1c Holter monitor Specialized workup for young stroke PFO Study, MES Study Referral to: ? Rehabilitation specialist ? Speech therapist ? Dietician ? Occupational therapist ? Medical team Follow-up: CTA, CT angiography; HbA1c, glycated haemoglobin; MRA, MR angiography Follow-up plan and 90 day mRS

Locations

Country	Name	City	State
Pakistan	Fauji Foundation Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Core Measure Delivery	• Primary outcome measure will be successful implementation of the stroke care model as measured by survey done at the end assessing engagement and ability to continue the program in future and ability to implement the program across institutions. This will be measured by the NIHSS training, stroke education, awareness of core measures, the regularity of following the core measure and data collection.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary	Modified Rankin Scale	Modified Rankin Scale is a 6 point disability scale from 0-6, and a greater score means worse outcome.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
Secondary	New ischemic stroke or Transient Ischemic Attack:		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
Secondary	Hemorrhagic transformation:		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
Secondary	Intracranial hemorrhage:		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
Secondary	Death		From date of inclusion in the study until the date of discharge