Six Key Startup Considerations for Implementing Home Healthcare

Does it feel overwhelming to think about implementing home healthcare in your trials? It certainly can be, and if you are considering this path, keep these six startup considerations (and tactics) in mind to help you stay on top of your strategy and navigate common pitfalls.

Design:

Every clinical study is different and knowing the strategic needs of each study should be your starting point when initiating your design discussion. To name a few study factors, the frequency of dosing, safety profile, duration of study, and patient population are all critical factors to align

If the study is complex, home health care may not be the best approach, but that doesn’t mean the conversation stops. There may be other ways that you could implement some form of virtualization into your trial (e.g., e-consent or ePRO). Keep in mind, the study design isn’t an all-or-nothing approach. An example of an area that may be difficult to achieve in a home care setting may be the collection of multiple pharmacokinetic (PK) samples. This may be difficult since the assigned nurse may not have capacity to stay at a patient’s home for a significant timeframe, and additionally, the processing of these laboratory samples for analysis may also impose unnecessary challenges.

Capabilities:

Dive into the important questions when you’re assessing your study’s requirements so that you can better understand the capabilities of those you partner with, like do you plan to partner with certain Investigators, is there a large patient population in certain areas, and what geographic areas will you target?

The experience of your vendor’s in target countries will be crucial in planning to ensure avoidance of unnecessary obstacles and reducing the need for managing multiple vendors, which invites its own added complexity. Areas where planning may also be important could be understanding if a country has certain credentials requirements for home care, if a country may not allow for home care in certain circumstances, and if there are requirements of whether certain languages are also recommended to be outlined in the protocol.

Additionally, it is equally important to assess institutions you will be partnering with and to have those discussions ahead of time during planning and pre-study visits. Questions such as whether the institution requires multiple nurses to see a patient at home, if there are requirements for certain agreements with a home care vendor (e.g., data privacy or service-level agreement), if the facility simply does not allow for home care, or if the institution has their own home care team that you could partner with, are all key considerations to keep in mind.

Including your investigators and study coordinators in planning activities is important because your site team has experience across multiple studies and are great advocates for their patients. 

Systems:

When implementing home care in trials, remember to consider how systems interact and are impacted.

For example, when building EDC, consider the following:

• Ensure you have designated fields to show whether the visit occurred at home or on-site
• When your home care trip reports or amendments are required resulting in updates to the EDC, ensure alignment with the database and home visit reports are not overlooked
• If you are considering an automated payment system for site reimbursement through EDC, when building your budgets, ensure you allow for flexibility between onsite and remote visits by using different arms since a patient can return to the site for an onsite visit at any time for an unscheduled visit

When building IVRS, consider the following:

• The drug will need to be prepared and sent to a patient’s home; therefore, IVRS would need to be registered ahead of time to accommodate shipping and preparation in time for the next visit  
• With a drug is being registered in advance of the home visit, it is important to remember the date of the visit will not be accurate since the date will be considered the date the drug was called in
• Consider designing your IVRS notifications to perhaps cover the date the drug was ordered instead of the date of visit to ensure accurate filing
• If using a central pharmacy, have a plan in place to ensure if the pharmacy does not receive notification in time so that escalations can occur in time for the drug to be shipped for the scheduled visit

Monitoring:

Consider if monitoring may be performed remotely and document the implementation in your monitoring plan specifying which assessments may be performed remotely and at what frequency.  Leveraging remote monitoring may help with cost efficiencies while implementing home health care.  For example, if most visits are in the home setting, the de-identified visit reports will be sent electronically to sites for data entry. Leveraging an option to have CRAs receive a copy of these trip reports would be a useful practice and reduce onsite frequency. Additionally, if a central pharmacy is utilized, consider that the pharmacy will also need to be monitored.

Consent:

When drafting consent, solicit feedback from the home care vendor ahead of time for approval of vendor language (i.e., think data privacy, archival of records etc.). Your team may also consider how you would like to build your consent, for example, do you want a separate home care consent prepared or combined with the master? If you separate the home care consent form and home care is not approved by a country, there would be no need to amend the consent. Alternatively, if the study has multiple consents (i.e., assents, sub-study, sample processing etc.), low risk region(s), and a single vendor, then having one consent may simplify the volume to manage. This will likely be more beneficial if you are operating with multiple vendors in multiple countries for management when there are circumstances in place for certain countries for home care.   

Also, consider the use of eConsent during startup.  eConsent can really help streamline and manage activities to make the entire consenting and management process more seamless. This will benefit everyone on the study (i.e., patients, site, sponsor, CRO, CRAs).  Having eConsent will help avoid missed entries and aid in version control to name a few (and will even save some trees).

Additionally, consider if your study would allow for the drug to be shipped to a relative’s house or vacation home depending on the frequency of dosing and the length of the trial. If you allow for the drug to be shipped to a different location, consider how this would be documented in the consent language and/or how this would be documented separately?

Clear communication and alignment for amendment implementation will also need to be considered between all parties (site, home care, and CRO/sponsor) to ensure it is clear when the patient has returned to the site to consent again. It will be beneficial to discuss the ongoing plans for this type of communication throughout the study especially if procedures change in amendment. For example, a form could be sent prior to each visit with the consent version completed by the site.

A Different Experience

The overall experience for a patient and home care nurse is different than an onsite experience. A nurse coming into the patient’s home is more personal, and more conflict may arise in this setting. Nurses may not feel comfortable and a patient may request a new nurse, just to name a few scenarios. Overall, being flexible and communicating this nature at the beginning will be important to ensure frustrations with turnover and delays are clear.

Outside of the above, operationally, other areas to keep in mind:

• Turnover: Turnover will happen. It can take time to identify a new nurse if a backup was not already identified. This often takes about eight weeks. In the instance, the patient will need to be able to go back to the site
• Remote Locations: Identifying a nurse can also be a challenge for some patients living in very remote locations. This could impact the number of available nurses, and in certain situations, a nurse may never be identified for a patient
• Off-Hour Request: If a patient would like to see their nurse off-hours (i.e., evening/weekend), identify if this will be acceptable to your team, the Investigator, and if deemed acceptable with the Investigator and the team and will there be a cost impact for off-hour visits?
• Set schedules: As amendments occur and planning kicks off, it is important to remember that nurses have planned schedules; therefore, hoping to use the nurse during unplanned visits in certain instances will likely be a difficult request

Overall, there will be hurdles while you’re implementing any home care trial; however, we have to appreciate we are never without challenges in our industry. Comparing implementation to the time and effort and resistance it took to implement electronic data collection methods is a great way to think of this moving forward. As we move forward with the future of clinical trials, we are in an exciting time for the industry as we see continued success with the adoption of more creative trial designs and operational tactics.