Home nursing in clinical trials: Result from semi-structured qualitative interviews (2024)

Regulatory environment and guidance

India is still on a journey to empowering patients toward the right to health and access to care at the grass-root level.[2] While decentralizing clinical research may be too early (for the Indian health-care system), there is a critical need to review legal, regulatory, and practical barriers to operationalizing a DCT. In addition, dealing with the above pointers becomes more crucial in scenarios where IEC might deliberate the use of a DCT on a case-to-case basis (as in the COVID-19 pandemic) after weighing in the operations that could compromise patient safety, site indemnity, and safety of the vulnerable population. Therefore, a definite set of recommendations are suggested as we move into the HHC space for the effective implementation of DCTs. These include:

1. Reviewing of procedures and assessment of the feasibility of HNCT solutions by IRB/IEC according to the pool of patients enrolled for the study and then define site standard operating procedures (SOPs) and monitoring mechanisms

2. Developing a regulatory guidance document on DCT (including HNCT), with expectations around:

   • Essential documents including study protocol, consent form, qualification of personnel/HNCT providers, SOPs, and oversight mechanism

   • Investigator responsibilities include oversight of participants’ care and potential delegation of activities in remote CTs

   • Data collection activities (e.g., ECG, vital signs, local laboratory blood/urine sample collection, etc.).

3. Engaging partners, collaborators, stakeholders (legal and regulatory), and trial participants at the earliest stage of DCT planning and design

4. Developing consensus on definitions for terms that are central to DCT design and conduct. E.g., “investigational site,” “home nursing,” etc.

5. Reviewing and modifying existing laws governing CTs, medical practice, data privacy, and telemedicine, easy-to-comprehend policies, and processes for conducting HNCTs

6. Registering home nursing providers and defining guidelines for them

7. Acknowledging home health care as a distinct care segment by various councils and associations

8. Covering risks by insurers, government bodies, trial sponsors, and employers, as applicable

9. Reporting system for third-party evaluation of processes to overcome constraints in achieving standardization while delivering home care.

Training and oversight

There is an acute shortage of skilled workforce in CTs,[3] and there is no formal recognition for community nursing programs. This is due to a lack of awareness/knowledge about the domain of HNCT. Therefore, there is a shortage of trained staff or resources to provide technical knowledge of HNCT protocols. The shortage of trained personnel can be met by providing training in basic procedures such as equipment handling, grooming, and ways to communicate with caregivers/trial participants at home. However, there is no standardized program for home health nursing in India. Here, a set of expert-oriented recommendations can strengthen the training and oversight requirements needed for successfully implementing HNCT. These include:

1. Ensuring that protocol-defined processes are followed by trained and skilled nurses/technicians with appropriate investigator oversight and diligence

2. EC preparedness - IEC/IRBs monitoring the sites and reviewing SOPs (if any) other than implementing trial as designed, pursuing home nursing, safeguarding confidentiality, addressing adverse events, checking the quality of personnel training, and ensuring adherence to protocol

3. Capacity building - DCT designs must ensure adequate training and resource availability around HHC for investigative sites

4. Well-defining of home nursing requirements in the DCT protocol

5. Ensuring partnership between key stakeholders (institution, sponsor, and service providers) to build capability by developing training curriculums, accreditation, and SOPs to create a synergistic team of a community of trial experts, health-care staff (trained in HNCT) that could usher in an ecosystem which supports HNCT.

Supply logistics

Home nursing requires the shipping of investigational medicinal products, carried either by home nursing staff or sent directly to patients’ homes. For this to occur, there must be an assurance of drug stability (maintaining of cold chain if required), appropriate storage facilities in the patient’s home, and measures to prevent unauthorized access to ensure proper storage of relevant materials with minimal study interruptions.[4] Hence, to ensure an adequate supply of logistics required in HNCT, it is recommended that:

1. Home nursing staff is equipped with all the necessary tools/materials, logistical support, technical/IT know-how, and management skills for remote health-care delivery, including handling unforeseen events

2. Features of DCT be incorporated within a traditional CT by introducing remote methodologies with an amendment to an existing protocol where infrastructure is already established and safety is well characterized.

The above recommendation, in particular, will allow investigators/sponsors to gain logistics experience, evaluate user compliance, and compare data quality to data obtained from traditional CT methodologies.

Safety monitoring

Remote safety monitoring procedures are critical for home nursing in DCTs, challenging to say the least, especially if any new drug trial or vulnerable patient population in a chronic state is being included. Some of the critical observations/challenges which were identified in this aspect include [Figure 1].

Recommendations to address the above challenges include:

1. Safety training - Investigative staff, nurses, patients, and caregivers should be trained on all safety-related processes unique to DCTs

2. Protocol Safety Monitoring Plan - Protocol-specific safety monitoring and communication escalation plans should be developed for trial participants, trial personnel, third-party vendors, and investigators. In this, training home nursing staff on handling (and timely reporting) an adverse event in close partnership with investigators while remote may be an important consideration

3. Obtaining participant feedback throughout the trial design and implementation

4. Adequately resourcing sites to review data on time and have contacts/infrastructure in place to react over distance accordingly, as necessary

5. Effective participant training and education for DCTs that rely on individual participants as partners in the research and safety reporting

6. Designing and incorporating simple safety reporting mechanisms using mobile technologies.

Data privacy

Investigators, home nursing staff, sponsors, clinical research organizations, IRBs, and other parties handling data may require to access data remotely (probably across locations) or handled by diverse staff and maintain privacy as per standards. Another problem is protecting patient privacy (stored on connected devices) and the information transmitted through connection services. Hence, a reliable cybersecurity system is a must if private patient data are to be stored and transmitted securely in a DCT (unlike traditional trials that use centrally firewalled local data systems). This can be ensured through expert recommendations such as:

1. Ensuring data integrity and maintaining it in a constant state

2. Adequately considering data handling, storage, and record-keeping while designing a regulatory framework around HNCT

3. Developing a data flow management plan for appropriately handling data according to the trial protocol.

Partner ecosystem

As with traditional trials, the investigator is responsible for ensuring that nursing care and trial procedures are conducted consistently according to the investigational plan.[5] However, in DCTs, there is a requirement for visits from mobile health-care personnel (HCP) to investigative sites to promote participant compliance and retention by providing convenience and comfort in the home, office, or if required, while traveling out of town. To ensure this, experts recommend to:

1. Create an ecosystem that includes mobile HCP vendors - Mobile HCPs should be trained in good clinical practices, trial-specific requirements, human participant protections, data protection, and safety reporting

2. Develop SOPs focused on applicable activities (such as specimen storage, shipping, and policies around travel/accommodations), which can be utilized by trial operators using mobile HCPs

3. Consider using mobile HCPs vendors with experience in CTs

4. Help trial partners create a safe environment for HHC nursing practice and support positive patient outcomes

5. Maintain a working relationship with government bodies, press and media, and the self-help group community to share information on ongoing and planned activities.

In addition, trial service providers could proactively partner with relevant stakeholders to establish an ecosystem for HNCT by improving logistics management with proper transport and transfer support, good monitoring of service delivery through software and manual inputs, focus on accuracy and continuity of effective care, leverage access to technological know-how, and resources to usher in more confidence for the HNCT system.

Note: Mobile HCPs may offer a way for prospective trial participants to participate in trials regardless of trial duration; frequency of visits; disease state; distance to travel to the investigative site; school, work, or family obligations; or vacation/travel plans.

Access to care at the grass-root level

Access to home nursing services in remote/rural areas is limited, making it challenging to provide pan-India coverage. Concerns include an absence of necessary infrastructure, uncertainty around patient availability and location, the safety of home nursing staff, and hesitation of patients and their caregivers toward home nursing. Consequently, to improve access to the grass-root level, experts recommend:

1. Building confidence in the participant/caregivers through transparent and simple processes

2. Recognizing and taking steps toward patient-centricity in the trial protocols.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest

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