Decentralized clinical trials (DCTs) are transforming the way we conduct medical research, making participation more accessible, patient-centered, and flexible. In these trials, study procedures are often conducted at the patient’s home, reducing the need for frequent trips to clinical sites. For study nurses, this shift brings new responsibilities and considerations to ensure both protocol compliance and patient safety.
To support this, we’ve created a comprehensive checklist for study nurses conducting decentralized trials at patients’ homes, covering everything from pre-visit preparation to post-visit follow-up. This guide ensures that each visit runs smoothly and efficiently while keeping the patient at the heart of the trial process.
Checklist for a study nurse conducting a clinical research visit in home:
1. Pre-Visit Preparation
- Review patient’s medical history and study protocol.
- Confirm patient’s availability for the scheduled visit.
- Ensure necessary study documents (e.g., consent forms, case report forms) are complete and accessible.
- Prepare and pack required medical equipment and supplies:
- Personal protective equipment (PPE)
- Lab kits (e.g., blood draw supplies)
- Diagnostic tools (e.g., BP monitor, ECG)
- Sample collection materials (e.g., vials, swabs)
- Verify the transportation and proper storage of study medications (if applicable).
- Bring a mobile device or tablet for real-time data entry (if required).
2. Arrival at the Patient’s Home
- Confirm patient’s identity and verify contact information.
- Follow infection control protocols (hand hygiene, use of PPE).
- Ensure patient comfort and privacy during the visit.
3. Patient Consent and Documentation
- Re-confirm informed consent has been provided (if required).
- Review the study protocol and explain the procedures to the patient.
- Address any patient questions or concerns.
- Ensure patient signatures are recorded where necessary.
4. Data Collection and Study Procedures
- Conduct baseline health assessments (e.g., vitals, physical exam).
- Administer study-specific procedures (e.g., medication, injections).
- Perform sample collection (e.g., blood, urine, swabs) per protocol.
- Label and store biological samples in accordance with study guidelines.
- Monitor for and document any adverse events or side effects.
5. Patient Education and Support
- If applicable, provide instructions for study medication (dosing, storage, etc.).
- Educate the patient on how to self-monitor or report symptoms.
- Explain the next steps in the trial process and upcoming visits.
- Offer contact information for follow-up questions or concerns.
6. Data Entry and Documentation
- Record all findings and procedures in real-time (via tablet or paper CRFs).
- Document any deviations from the protocol and their justifications.
- Ensure patient-reported outcomes (PROs) are collected, if required.
7. Post-Visit Follow-Up
- Safely transport biological samples to the lab as per protocol.
- Ensure proper disposal of used medical supplies and PPE.
- Report any urgent patient health issues to the trial investigator immediately.
- Schedule the next visit or follow-up appointment with the patient.
8. Closing the Visit
- Verify all data is collected and entered accurately.
- Thank the patient and remind them of any upcoming trial milestones.
- Ensure the patient has the necessary contact details for any further assistance.
By following this checklist, study nurses can ensure they conduct decentralized clinical trial visits effectively while maintaining protocol adherence and patient safety.
Want to learn how we can support your home-based trial?
Our mobilehealth services facilitate remarkable experiences within the comfort of patients’ own homes. Decentralized and hybrid clinical trials provide greater choice for patients to participate in studies on their own terms. This has a direct impact on recruitment and retention rates and significantly improves clinical outcomes. From the initial design of patient-first protocols and equipment logistics to the final stages of visit planning, scheduling, and management our services encompass every aspect of the home-based clinical trial journey.
Through our partner talent and recruitment agency, seacolehealth, we recruit expert healthcare practitioners trained to the highest standard in conducting decentralized trial visits.
