REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers (RESPPECT Trial)

NCT ID: NCT03861494

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2021-09-14

Brief Summary

This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education.

Detailed Description

This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education. Patients who meet inclusion and not exclusion criteria and provide signed informed consent will be randomized to one of the two groups. Assignments will be made based on the order of entry into the stroke study database where every other patient entered will be assigned to the treatment group. If the patient's caregiver is the primary person responsible for administration of medication, determination of meals and activity, the caregiver may be enrolled instead of or in addition to the patient. This will be determined by preference of the patient and caregiver after discussion of their usual practice. A Neuroscience trained Registered Nurse is a nurse who has received specialized education from the organization regarding care of patients with stroke and other neurologic illnesses. The Neuroscience trained Registered Nurse will provide all patients with basic stroke and risk factor information, educational materials and follow-up. The usual care group of patients will receive education provided by the Neuroscience trained Registered Nurse who provides care for the patient daily. Education will be provided on an ongoing basis throughout the hospital stay with additional focused education provided at the time of discharge (within 24 hours of hospital discharge). The education will include written and verbal information. Educational content focuses on a variety of topics of stroke prevention, detection and management. The enhanced stroke education group will receive the same usual care for patient education given by the Neuroscience trained Registered Nurse. The enhanced stroke education patient will receive a one -time enhanced specific goal-directed educational experience given by a specifically trained Stroke Coordinator on the day of discharge. The enhanced education is tailored to the unique risk factors of the patient and key concepts for stroke prevention, detection and management The patient will be given goals specific to their personal risk factors. Emphasis on specific goals for lifestyle change are emphasized. Verbal feedback of key concepts is encouraged.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enhanced Stroke Education

This group of participants will receive enhanced education provided by the Stroke Coordinator at the time of discharge. The enhanced education session will last 30 minutes with the participant.

Group Type: OTHER

Enhanced Stroke Education

Intervention Type: BEHAVIORAL

In addition to the general stroke education materials and verbal education, the enhanced stroke education group will receive a personalized verbal and written information addressing the patient's specific risk factors including their current status and goals, laboratory values and goals, and current blood pressure and goal. Specific stroke type and etiology is discussed, medication including indication, dose, frequency, physical activity goals, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, and education over the importance of keeping follow up appointments including Stroke Clinic. Verbal feedback of key points is encouraged.

Usual Stroke Education

This group of participants will receive the usual stroke education provided by the usual Neuroscience Registered Nurse throughout the hospitalization and at the time of discharge.

Group Type: OTHER

Usual Stroke Education

Intervention Type: BEHAVIORAL

The usual stroke education group will receive general stroke education including written and verbal information about signs and symptoms of stroke, best practice to engage medical treatment if stroke occurs, general information about heart healthy diet and need for daily physical activity as well as need for compliance with medication recommendations. The education is incorporated with routine patient care and as allowed during quiet times. On the day of discharge, the patient will receive written materials reviewing stroke symptoms, risk factors, heart healthy diet and follow up appointments. The patient will receive written and verbal information about medications including indication, dose, frequency, physical activity goal, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, the importance of keeping follow up appointments including Stroke Clinic.

Interventions

Enhanced Stroke Education

In addition to the general stroke education materials and verbal education, the enhanced stroke education group will receive a personalized verbal and written information addressing the patient's specific risk factors including their current status and goals, laboratory values and goals, and current blood pressure and goal. Specific stroke type and etiology is discussed, medication including indication, dose, frequency, physical activity goals, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, and education over the importance of keeping follow up appointments including Stroke Clinic. Verbal feedback of key points is encouraged.

Intervention Type: BEHAVIORAL

Usual Stroke Education

The usual stroke education group will receive general stroke education including written and verbal information about signs and symptoms of stroke, best practice to engage medical treatment if stroke occurs, general information about heart healthy diet and need for daily physical activity as well as need for compliance with medication recommendations. The education is incorporated with routine patient care and as allowed during quiet times. On the day of discharge, the patient will receive written materials reviewing stroke symptoms, risk factors, heart healthy diet and follow up appointments. The patient will receive written and verbal information about medications including indication, dose, frequency, physical activity goal, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, the importance of keeping follow up appointments including Stroke Clinic.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients hospitalized with primary diagnosis of acute or subacute ischemic cerebral infarction
• 18 years of age or older
• English speaking
• admitted to hospital Sunday through Thursday
• patient or responsible primary caregiver able to understand and provide informed consent
• prognosis for survival greater than 6 months
• one or more vascular risk factors (HTN, DLP, current smoker, DM, obesity)
• live in NWA area (Benton, Boone, Carroll, Madison, and Washington counties),
• have a working phone.

Exclusion Criteria

• admitted with transient ischemic attack
• admitted with an intracerebral hemorrhage
• experience an in-hospital ischemic cerebral infarction
• hospital to hospital transfer patients
• nursing home as primary residence before or after discharge
• hospice
• inability to comply with post discharge follow up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Margaret Tremwel

Stroke Program Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret Tremwel, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Regional Medical Center

Locations

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Countries

United States

Other Identifiers

WRMC

Identifier Type: OTHER

Identifier Source: secondary_id

WRMCRESPPECT

Identifier Type: -

Identifier Source: org_study_id