This checklist provides a comprehensive guide for study nurses conducting home visits as part of clinical research. Adhering to this checklist ensures consistent, high-quality data collection and patient care. Remember to always consult the specific protocol for your study, as requirements may vary.
Before the Visit:
- Review the Study Protocol and Case Report Form (CRF): Familiarize yourself with all relevant procedures, data collection points, and specific requirements for the visit. Ensure you have the correct version of the CRF.
- Check Patient's Medical Records: Review any existing medical records, lab results, or previous visit notes to prepare for the visit and anticipate any potential issues.
- Confirm Appointment: Verify the appointment time, address, and any special instructions or access requirements with the participant.
- Gather Supplies: Prepare all necessary equipment, including the CRF, pens, medication reconciliation forms (if applicable), scales, blood pressure cuff, pulse oximeter (if applicable), any other study-specific equipment, and appropriate PPE (personal protective equipment). Check battery levels and equipment functionality.
- Plan Route and Transportation: Ensure you have a map or GPS and account for potential traffic or travel delays.
- Review Patient Consent and Confidentiality Procedures: Refresh your knowledge of informed consent procedures and the importance of maintaining patient confidentiality.
During the Visit:
- Introduce Yourself and Verify Patient Identity: Confirm the participant's identity using two identifiers (e.g., name and date of birth) as per protocol.
- Confirm Consent: Reiterate the informed consent process and ensure the participant is comfortable proceeding. Address any questions or concerns they may have.
- Observe Patient's Environment: Note any relevant environmental factors that could impact the study (e.g., safety concerns, medication storage, adherence to study-specific dietary guidelines).
- Medication Reconciliation: (If applicable) Conduct a thorough medication reconciliation, comparing the participant's reported medications to the medication list documented in their medical records.
- Vital Signs: Accurately record and document vital signs, following standard procedures.
- Physical Examination: (If applicable) Conduct any required physical examinations, documenting findings meticulously on the CRF.
- Data Collection: Complete all data collection activities as specified in the study protocol. This may include questionnaires, physical measurements, blood draws (if applicable and trained to do so), or other assessments.
- Adverse Event Reporting: Meticulously document any reported adverse events, following the protocol's guidelines for reporting.
- Answer Patient Questions: Address any questions or concerns the participant may have about the study, medication, or their health.
- Provide Education and Support: Offer necessary education and support related to the study, medication adherence, and overall health.
After the Visit:
- Complete the CRF: Ensure the CRF is completely and accurately filled out, including any observations, assessments, and significant events.
- Review Documentation: Review all documentation for completeness and accuracy.
- Submit Documentation: Submit the completed CRF and any other required documentation to the appropriate personnel according to the study's timeline.
- Schedule Follow-up Visit: (If applicable) Schedule the next home visit and communicate the details to the participant.
- Follow Up on Action Items: Any action items identified during the visit, such as contacting a physician or arranging for additional testing, should be followed up immediately.
Possible Additional Questions & Considerations:
- What are the specific inclusion/exclusion criteria for this study? Ensure the patient still meets these criteria.
- What are the study-specific procedures for handling missing data?
- What are the safety procedures for handling biohazardous materials? (If applicable)
- What is the emergency contact information for the study team? Have this readily available.
This checklist serves as a framework. Always refer to the specific protocol and standard operating procedures for your study to ensure compliance and patient safety. Remember to document everything thoroughly and accurately.
