Screening and Preparing for a Study Visit
There are several steps that must be taken prior to conducing a study visit.
Many human subject protocols require participants to be scheduled for specific research visits. The number and length of time required for a research appointment to occur is highly dependent on the specifics of the study design. The specifics of the appointment are highly dependent on the location of the appointment. Appointments can occur in inpatient units, outpatient clinics, lab draw locations, diagnostic testing locations, research labs, Clinical Research Center (CRC), at the participant’s home or a neutral site convenient for the participant. The visits where the study will occur must be listed with the IRB.
It is important to set the expectations of each visit for the participant. For example, where the visit will take place, how long the visit will take, tasks to be completed at the visit, what tasks are clinical vs. what is research related, special instructions the participant must follow prior to the visit, directions and parking information, whether or not compensation for time or parking will take place and who will be involved in the visit. This should all be included in a confirmation letter.
Once the visit is scheduled, follow-up contact within a week prior to the visit by a phone call to the participant. It is essential to reinforce the requirements of the study and ensure there has not been any changes since the last time you spoke (broke a leg, new infection, changed medication). Some of these changes might make the patient ineligible and would be better to catch ahead of time.
It is important to be understanding of the participant’s personal schedule and to help identify research visit times that are convenient for the individual to commit to without sacrificing protocol compliance. If the study lasts a while and you know the study visit windows, it is good to provide it to the subject to help them plan ahead of when you might want them to come back for visits.
Access Subject Schedule by Enrollment
Prior to each study visit, the research team must be prepared for all known and unknown tasks that may need to be completed per protocol. If applicable, physician orders need to be completed and authorized for lab draws, study medication and additional testing; research lab kits should be prepared and available to the appropriate clinical team drawing the samples; participant questionnaires should be prepared; flowsheets required for research documentation should be made available to the appropriate team members; and any end of study visit items should be readily available if the participant decides to withdraw from the study or is removed from the study due to adverse events or investigator discretion, etc.
Obtaining a Medical Record Number
A medical record number (MRN) needs to be assigned to a research participant if they will be admitted to the hospital in the outpatient or inpatient setting or if they will undergo any medical tests that need to be processed by a hospital lab. When first scheduling the participant, research staff can check whether a medical record number already exists for the individual by checking IHIS. If they have a medical record number, that number will be used to identify them for any hospital-related admissions or tests. If they do not have a medical record number you are able to create a new patient in IHIS. Talk with your clinical research manager about how your department wants the new MRN to be created.
Clinic Visits
Many studies at Ohio State recruit research participants from patients that are already scheduled for healthcare visits in the medical center or cancer center. If the study design is such that these visits can serve the dual purpose of study visit and doctor visits, then scheduling is relatively straightforward and involves coordinating with the clinical treatment team. Clinic and diagnostic testing appointments are scheduled in IHIS, the provider scheduling database. The research team can review the electronic medical record, for specific information on the visits scheduled. It is important to review the participant visits often, as they could be altered or canceled by someone else which may result in protocol compliance concerns or impact the anticipated activities for that day.
For research appointments that need to be scheduled in the Ohio State hospital or clinics, independent of the patient’s medical appointments, most of the scheduling is done by the hospital schedulers or you might have a point person to ensure you have the correct staffing needed for the research visit. However, it is still the responsibility of the research staff to communicate the specifics of the protocol visit, including the timing of the visits scheduled, how long visits are expected to take, complete any paperwork necessary, obtain physician order for lab or special testing that needs to be performed at a given visit.
Research Appointments
Many studies require that research visits take place in a location that is specifically equipped to carry out the research protocol. Space may be designed to administer specific computer questionnaires, to conduct interviews in a private setting, to be proximal to labs for obtaining and processing blood or other biological specimen or to medical equipment like research CT scans or MRI equipment that cannot be moved. Sometimes certain controlled environment or conditional experiences are part of the research visit. These visits will be arranged with the key research staff involved in the research visit and may not be formally scheduled in the medical center scheduling system. This can cause patients to get reminder calls about a research procedure that happens later in the day and it is separate from the time/location you had discussed for the consent procedure visit to take place. It is essential to send a research confirmation letter that lists the procedures to help clarify to the who, what when and where for the entire study visit.
Scheduling Off-Site Research Visits
There are research studies that allow the visits to take place in the participant’s home or another neutral location, more convenient for the individual. Off-site study visits pose some additional challenges to the research staff in the form of feasibility and safety.
Before scheduling a home visit, the research staff must assess if the visit tasks can be accomplished in the specific location. For example, is there a workspace sufficient to carry out lab draws and physical examinations, are there electrical outlets for medical equipment or laptop computers, etc.
The distance away from the study center needs to be taken into consideration as many studies have a travel limit for outreach research staff. Distance can also cause some feasibility issues such as timeframe that blood specimens must be processed to maintain the integrity of the sample. Other things to consider include how the data will be transported to and from the home or off-site study visit. If laptops are used to transport data, they need to be encrypted to ensure HIPAA compliance.
Safety is also a necessary consideration when conducting home visits. When a member of the research team goes to an unfamiliar area to conduct a study visit, at least one other coworker should know that the appointment is occurring. The researcher should communicate with the research team immediately before and after the study visit occurs. The safety of the research staff should always be the primary consideration over the completion of a study visit outside the research study center and appropriate judgment should be utilized.
Lab Result Reviews
When you receive lab reports your investigator will need to document that they have been reviewed. On any abnormal lab value the investigator must document if it is clinically significant. If it is documented as clinically significant then you will need to create an Adverse Event form. Sometimes the lab is related to other areas of the patient’s medical history so if it is abnormality, it can be documented as such. Great investigator write on the first batch of labs what the abnormal lab value correlates with in subject’s medical history (ie elevated glucose=subject is diabetic) so that reviewers can see that they reviewed all abnormalities seriously.
Below is a link to a sticker you can attach to printed reports that quickly documents that the investigator has reviewed the labs and then have your investigator sign off on it.