Medial Research Network

Home Trial Support (HTS) Staff FAQs

1. What precautions are MRN HTS Professionals going to take during the visit?

Based on national and internal guidelines, MRN has instructed all HTS healthcare professionals conducting home visits to follow the following standards. In summary;

• Aprons, gloves and surgical face masks should always be worn for HTS visits.  

• Handwashing must be thorough, with water (hot if possible) and soap and last at least 20 seconds. If clean water is not available, use hand sanitizer gel.

• Disposable paper towels should be used to dry hands for all visits.

• Hand sanitizer gel (or anti-bacterial hand wipes where provided) should be used between handwashes and as you enter or leave the home.

• Courier delivery - Per our standard HTS process, the courier driver is not allowed to enter the patient’s home during delivery of IMP or collection of laboratory samples. The HTS healthcare professionals will interact with the courier outside the patient’s home and will adhere to the social distancing guidelines whilst interacting with the driver.

2. Do HTS professionals wear masks?

MRN is taking guidance from local and global national health directives.

Although WHO guidance only advocates the use of masks when caring for patients with COVID-19, MRN has advised all vendors that standard single use surgical masks will be supplied to all HTS healthcare professionals. These can be used by the HTS healthcare professional and the patient for all HTS visits. If used, healthcare professionals will need to fit their own mask first before assisting the patient with fitting theirs.

Masks are to be disposed of along with the other waste from the HTS visit and personnel must ensure that waste is placed into two waste bags rather than the standard one bad (double bag procedure).

3. What kind of testing are MRN doing on RNs that are going to patients' homes?

We are following the pandemic international guidelines for healthcare workers where they are available. Testing of front-line staff is still not recommended on a routine basis in most countries. For patients at high risk of infection, the potential risk of the home visits needs to be assessed by the physician looking after the patient. If they feel home visits are not appropriate, they need to make alternate arrangements.

MRN has introduced guidance to minimise any risk of transmission between the healthcare professional and patient, using protective equipment appropriate for contact between asymptomatic patients and nurses. If either the healthcare professional or patient is symptomatic, then the visit is terminated and re-planned. We can make these guidelines available to the Principal Investigator (PI) to help their decision. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html

If any HTS healthcare professional is considered to be a suspected, probable or confirmed COVID19 case, with or without symptoms, they have been advised to inform their MRN Country Lead immediately and refer to local guidance from their local health provider.

All scheduled HTS visits will be re-allocated per back-up healthcare professional availability. The HTS healthcare professional will not resume work until an agreement has been obtained from MRN and their local health provider confirming they are clear of symptoms.

4. In your view, which type of study should be prioritized for Home Trial Support?

Our clients are seeing the need to move to a more home-based monitoring model to protect their trials and the patients. This is leading to an increase in requests for trial home support.

In order to cope with increased demand and ensure that we can deliver on projects won, MRN will be prioritising those studies that we have the greatest chance of helping. This means that we will focus on requests where we are asked to:

1. Ensure support for the whole trial
2. Look after patients already in the trial.

MRN will help the most if we support the whole trial - i.e. all countries within our capability and all sites (this should include those countries that are under the greatest pressure). Supporting the trial ONLY in countries under lockdown already is not ideal. This will allow us to do our best to support those patients in dire need AND to move recruitment around the countries and sites less affected to enable the study to complete successfully.

These trials will be prioritised in our triage process. Requests for support in limited countries, particularly just those in lockdown only, will get placed low down the priority list or maybe declined entirely.

In this manner, we will be able to assist the most clients, in the most efficient and successful manner possible.

5. Do you see any higher risk during COVID-19 for any procedure at home? (e.g. infusion)?

We don’t see a higher risk for infection for home infusions. It is part of standard HTS healthcare professional training to follow infection control measures to minimise or reduce the risk of cross-contamination. Patients are always treated as potentially infectious until proved otherwise (e.g. for Hepatitis, HIV etc). Hence HTS healthcare professionals routinely use gloves, aprons and face masks during home visits as part of the aseptic technique process when handling or administering parenteral medication (also for other tasks such as phlebotomy and handling body fluids).

6. How are you managing safety escalations in the event that a site closes/stops clinical research?

We are following the guidance provided by regulators to support clinical trial sites in continuing with research activities. Where sites are completely unable to continue their clinical trial activities, we would be limited in our ability to support home visits without the necessary PI oversight. If there is no investigator available to provide clinical support/oversight MRN would not be able to conduct any HTS visits for affected sites.

7. Do our HTS professionals need Personal Protective Equipment (PPE) when visiting patients?

PPE provision to Home Trial Support Staff has been described by the FDA and MHRA.

US, FDA - Protection of Healthcare providers is required for all confirmed and asymptomatic patients.

MRN and our vendors are following per country National and Local Health Authority Guidance related to travel within impacted regions or where restrictions have been applied. Currently, any travel restrictions do not apply to health care professionals or services related to delivery of healthcare. MRN has issued nurses with 'letters of authorisation' for travel in those+B11 countries where required.

Public Health England - COVID 19 Guidance for Homecare Provisions

8. Are there any travel restrictions for MRN nurses?

MRN and our vendors are following per country National and Local Health Authority Guidance related to travel within impacted regions or where restrictions have been applied. Currently, any travel restrictions do not apply to health care professionals or services related to delivery of healthcare. MRN has issued nurses with 'letters of authorisation' for travel in those countries where required.

 

Other FAQs:

- Country Coverage FAQs

- Expedited Start-Ups (ESU) FAQs

- General FAQs

- Supplies FAQs

COVID 19 FAQs
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