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

NCT ID: NCT04995146

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Retrospective 3 months cohort (admitted stroke patients)

Clinical stroke extended management pathway

Intervention Type: OTHER

1. Extracranial imaging

2. ECG in 2-7 days

3. DVT prophylaxis

4. Stroke educational material for patient and family Removal of Foley's catheter and start bladder management

5. Discharged on: Antithrombotic therapy OR Anticoagulation therapy▸ Antihypertensives ▸ Statins/cholesterol lower agent ▸ Antidiabetic agent

6. Fasting lipid profile, HbA1c

7. Holter monitor

8. Specialized workup for young stroke

9. PFO Study, MES Study

10. Referral to: ▸ Rehabilitation specialist ▸ Speech therapist ▸ Dietician ▸ Occupational therapist ▸ Medical team

11. Follow-up: CTA, CT angiography; HbA1c, glycated haemoglobin; MRA, MR angiography

12. Follow-up plan and 90 day mRS

Prospective pre-implementation "standard of core care quality measures" cohort

Clinical stroke extended management pathway

Intervention Type: OTHER

1. Extracranial imaging

2. ECG in 2-7 days

3. DVT prophylaxis

4. Stroke educational material for patient and family Removal of Foley's catheter and start bladder management

5. Discharged on: Antithrombotic therapy OR Anticoagulation therapy▸ Antihypertensives ▸ Statins/cholesterol lower agent ▸ Antidiabetic agent

6. Fasting lipid profile, HbA1c

7. Holter monitor

8. Specialized workup for young stroke

9. PFO Study, MES Study

10. Referral to: ▸ Rehabilitation specialist ▸ Speech therapist ▸ Dietician ▸ Occupational therapist ▸ Medical team

11. Follow-up: CTA, CT angiography; HbA1c, glycated haemoglobin; MRA, MR angiography

12. Follow-up plan and 90 day mRS

Prospective post-implementation "standard of core care quality measures" cohort

Clinical stroke extended management pathway

Intervention Type: OTHER

1. Extracranial imaging

2. ECG in 2-7 days

3. DVT prophylaxis

4. Stroke educational material for patient and family Removal of Foley's catheter and start bladder management

5. Discharged on: Antithrombotic therapy OR Anticoagulation therapy▸ Antihypertensives ▸ Statins/cholesterol lower agent ▸ Antidiabetic agent

6. Fasting lipid profile, HbA1c

7. Holter monitor

8. Specialized workup for young stroke

9. PFO Study, MES Study

10. Referral to: ▸ Rehabilitation specialist ▸ Speech therapist ▸ Dietician ▸ Occupational therapist ▸ Medical team

11. Follow-up: CTA, CT angiography; HbA1c, glycated haemoglobin; MRA, MR angiography

12. Follow-up plan and 90 day mRS

Interventions

Clinical stroke extended management pathway

1. Extracranial imaging

2. ECG in 2-7 days

3. DVT prophylaxis

4. Stroke educational material for patient and family Removal of Foley's catheter and start bladder management

5. Discharged on: Antithrombotic therapy OR Anticoagulation therapy▸ Antihypertensives ▸ Statins/cholesterol lower agent ▸ Antidiabetic agent

6. Fasting lipid profile, HbA1c

7. Holter monitor

8. Specialized workup for young stroke

9. PFO Study, MES Study

10. Referral to: ▸ Rehabilitation specialist ▸ Speech therapist ▸ Dietician ▸ Occupational therapist ▸ Medical team

11. Follow-up: CTA, CT angiography; HbA1c, glycated haemoglobin; MRA, MR angiography

12. Follow-up plan and 90 day mRS

Intervention Type: OTHER

Eligibility Criteria

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)

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

FUI/CTR/2020/8

Identifier Type: -

Identifier Source: org_study_id