Helena Baker

New technologies, social media and developments in the clinical trial process have made it possible for subjects to influence the way a study is conducted, leading to changes in patient care and in the traditional clinical study process.

 While developing the protocol for a clinical trial, it is important to understand the subject’s lifestyle.

 More and more trials are considering new methods that allow the subject to incorporate a clinical trial into their day-to-day life. One method includes bringing clinical research procedures to the subject, rather than the traditional method that dictates the subject goes to the investigative site. 

	A wide range of healthcare services can be performed in the patient’s home by a medical professional-usually a nurse. A nurse is able to visit a subject during a clinical trial and conduct aspects of the study in the home, leading to a more community-based clinical trial model. The offer of home visits to undertake some of the study procedures allows the subject to maintain his or her current lifestyle as much as possible. 

	Some benefits of homecare in a healthcare setting include reduction in the frequency of outpatient visits, quicker patient discharge, involving patients in their own care and reduced risk of cross-infection in certain patient groups.

 Increased support, chronic-disease management and patient-centric services are important factors in improving quality of life of those affected by long-term conditions.

	There is increasing evidence to suggest taking clinical trials to the patient’s home can improve standard of care, patient recruitment, patient retention and, in some cases, decrease costs. This article will look at evidence from patient care and clinical trials, and evaluate if homecare can be a driver of cost savings in a clinical study.

	Chataway et al. (2006) compared, from the patient’s perspective, the delivery of intravenous steroids to multiple sclerosis patients in a home and an outpatient setting. The outpatient group were patients that attended the hospital for treatment without staying overnight. Comparatively, the home group took a supply of the drug home, where a trained home healthcare nurse visited the patient to administer the therapy. These patients were experiencing a disease relapse and required three days of IV steroids in order to control their condition.

 This study looked at the economic impact of treating the patient in the home compared to the hospital outpatient setting and demonstrated clear economic benefits to homecare.

 Home administration was found to be the same or significantly cheaper than outpatient administration.

 Coordination of care (defined as patient’s experience of relapse management, e.g., comfort of setting treated and convenience of treatment) was significantly higher in the homecare group versus the outpatient group; other clinical outcomes, including administration of steroids, were equally safe and effective in both groups.

	Patel et al. (2015) assessed the efficiency and cost-effectiveness of hospital versus home-based therapy with oral amoxicillin for severe pneumonia in children in developing countries. The study concluded that the cost of hospital treatment compared to home-based therapy was significantly higher, a finding consistent with the recent World Health Organization (WHO) simplified guidelines that state the effectiveness of managing pneumonia in a home setting.

	Bowrey et al. (2015) reported on the value of home enteral feeding in selected subjects after oesophagectomy or total gastrectomy for cancer. This was found to be feasible, safe, could confer nutritional benefits, and was acceptable to subjects and their caregivers.

 Additional healthcare costs associated with homecare in this instance appeared to be neutralized by reduced healthcare costs in other areas.

 Therefore, suggesting homecare during a clinical trial is cost neutral.

	The patient dropout rates in longitudinal studies can introduce bias, facilitating subjects returning for follow-up visits and leading to underestimating the number of participants with complications: worse functional outcomes or mortality, e.g., major cardiac or neurologic morbidity and mortality, neurocognitive dysfunction, or functional decline.

 The option of having a homecare visit during a trial means study complications are more likely to be counted.

Peterson et al. (2012) found 11 additional complications in the homecare group compared to the routine follow-up group. The availability of homecare allowed the inclusion of the complications sustained by these participants in the study results. It is important to note the number of homecare visits required increased for participants over age 75, and patient retention rates were higher in the homecare group. Hence, these could be contributing factors that lead to increased complications being picked up in this group.

 After hospitalization, geriatric patients benefit from home visits.

	Buurman et al (2016) found that, although homecare had no significant difference on activities of daily life, it did decrease mortality at one and six months in geriatric patients after hospitalization. Homecare can increase 

safety during the vulnerable period after hospital discharge, although further studies are needed.

	When considering homecare clinical trials, it is also important to consider the safety of the nurse in the subject’s home. To prevent hazards, the nurse can conduct a full risk assessment during their first visit to the subject.

 In order to ensure patient safety in homecare visits, it is vital to train homecare nurses on the study protocol and adverse events as well as to debrief patients on the homecare visit process.

 Robust training on the therapeutic area, the procedures to be undertaken and a risk assessment to ascertain the appropriateness of homecare for the particular visit/study/disease area all help to ensure that home visits invite no greater risk than hospital visits.

	Molassiotis et al. (2009) observed a significant improvement in various clinical parameters as well as reduced service utilization (including the number of in-patient days) in patients with cancer receiving oral chemotherapy when a homecare nursing program was implemented. Managing the symptoms at home and nurse-patient relationships could contribute to these improvements.

	Chronic obstructive pulmonary disease (COPD) is a common cause of illness and death in many countries.

Mendes de Oliveira et al. (2010) demonstrated the effectiveness of a home-based self-monitoring pulmonary rehabilitation (PR) program (multidisciplinary intervention to care for COPD patients) to be the same as out-patient PR and a valid alternative for the management of COPD patients. Dropout rates dramatically decreased in the homecare group compared to the out-patient group; this is likely due to the fact that carrying out PR at home is logistically easier than traveling to the clinic multiple times a week.

 Therefore, home-based treatment increases the geographical reach of subjects and provides trials greater access to patients who would otherwise be unable to participate in a study.

	Homecare allows the conduct of clinical trial visits in the subject’s home, decreasing the need to travel to the site. This reduces the burden on patients and the sites, directly increasing patient recruitment and retention.

	In a longitudinal randomized controlled study, Peterson et al. (2012) found 25% of participants required home visits, which led to a 4% overall dropout rate. Geriatric participants-those with a high medical burden and those with a large number of complications-have a greater risk of dropping out of trials.

 Factors that increase retention when using homecare include:

		Informing participants of study requirements and ensuring they understand what is required during a home visit

		Study staff should strive to develop positive relationships with participants

		Refusal of one follow-up does not equate to a dropout

		Making homecare an option to participants at risk of leaving the study, especially when assessing final study complications

	A sponsor used homecare during an oncology study requiring routine blood sampling from 63 subjects across six UK sites, every two weeks for two years.

(see Figure 1). Visits alternated between hospital, outpatient and homecare.

 Five out of six sites utilized homecare; those sites increased patient recruitment by 63%, with a retention rate of over 98% (only one patient dropped out, due to pregnancy).

	Another sponsor used homecare in a long-term complex oncology study, which required compounding within 24 hours of drug administration for 57 patients across three UK sites.

 Subjects received infusions every two weeks for an average of three years. alternating between homecare and inpatient administration.

 The study achieved a patient retention rate of 98%, with only one patient withdrawing.

 The post-trial patient assessment yielded the positive outcomes outlined in Figures 2 and 3.

	Providing clinical homecare nursing visits at more than just the traditional homecare level has economic benefits for clinical studies. This article illustrates how clinical homecare can directly affect cost, for example, by bringing the trial to the patient instead of the patient travelling to the study site. Allowing patients to have access to homecare during clinical studies is beneficial to the patient, site and sponsor. Depending on the intensity of the approach, a combination of homecare and outpatient visits can increase standard of care, improve compliance, decrease costs and boost patient recruitment and retention.

 is Vice President of Nursing at The Medical Research Network (MRN); 

 is a Business Development Executive at MRN

	1. Sharma, N. “Patient-centric approach for clinical trials: Current trend and new opportunities,” 

	2. Colquhoun, A. “Clinical homecare providers are warmed up and ready,” 

http://www.pharmaceutical-journal.com/news-and-analysis/news/clinical-homecare-providers-are-warmed-up-and-ready/11027177.article

	3. Hackett, M. “Homecare medicines – towards a vision for the future” (Department of Health, London, 2011)

Supporting people with long term conditions: an NHS and social care model to support local innovation and integration

	5. Patel, A., Bang, A., Singh, M., Dhande, L., Ravi Chelliah, L., Malik, A., Khadse, S., and ISPOT Study Group. “A randomized controlled trial of hospital versus home-based therapy with oral amoxicillin for severe pneumonia in children aged 3 – 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study,” 

	6. Chataway, J., Porter, B., Riazi, A., Heaney, D., Watt, H., Hobart, J., Thompson, A. “Home versus outpatient administration of intravenous steroids for multiple-sclerosis relapses: a randomized controlled trial,” 

	7. Bowrey, D., Baker, M., Halliday, V., Thomas, A., Pulikottil-Jacob, R., Smith, K., Morris, T., and Ring, A. “Randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on pilot and feasibility study,” 

	8. Peterson, J., Pirraglia, P., Wells, M., and Charlson, M. “Attrition in longitudinal randomized controlled trials: home visits make a difference,” 

	9. Buurman, B., Parlevliet, J., van Deelen, B., de Haan, R., and de Rooji, S. “A randomised clinical trial on a comprehensive geriatric assessment and intensive home follow-up after hospital discharge: The Transitional Care Bridge”, 

	10. Buurman, B., Parlevliet, J., Allore, H., Blok, W., van Deelen, B., van Charante, E., de Haan, R., and de Rooij, S. “Comprehensive geriatric assessment and transitional care in acutely hospitalized patients: The Transitional Care Bridge randomized clinical trial” 

http://archinte.jamanetwork.com/article.aspx?articleid=2491684

	11. Gershon, R., Pogorzelska, M., Qureshi, K., Stone, P., Canton, A., Samar, S., Westra, L., Damsky, M., Sherman, S. “Home health care patients and safety hazards in the home: Preliminary findings,” In: Henriksen K, Battles JB, Keyes MA, Grady ML, eds. 

Advances in Patient Safety: New Directions and Alternative Approaches

 Vol 1: Assessment, (Rockville, MD, 2008) 

http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Gershon_88.pdf

	12. Molassiotis, A., Brearley, S., Saunders, M., Craven, O., Wardley, A., Farrell, C., Swindell, R., Todd, C., and Luker, K. “Effectiveness of a home care nursing program in the symptom management of patients with colorectal and breast cancer receiving oral chemotherapy: a randomised, controlled trial,” 

	13. Mendes de Oliveira, J., Studart Leitão Filho, F., Malosa Sampaio, L., Negrinho de Oliveira, A., Pastrello Hirata, R., Costa, D., Donner, C., V.F. de Oliveira, L. “Outpatient vs. home-based pulmonary rehabilitation in COPD: a randomized controlled trial,” 

	14. Medical Research Network (2015). Case History 2 – Recruitment. Available at 

http://www.themrn.co.uk/case-history-2-recruitment-p65.aspx

	15. Medical Research Network (2015). Case History 3 – Retention. Available at 

http://www.themrn.co.uk/case-history-3-retention-p66.aspx

Articles

Examining the cost and patient recruitment and retention benefits of bringing clinical research procedures to the subject’s home.

An Economic Evaluation of Clinical Homecare

 More and more trials are considering new methods that allow the subject to incorporate a clinical trial into their day-to-day life. One method includes bringing clinical research procedures to the subject, rather than the traditional method that dictates the subject goes to the investigative site. A wide range of healthcare services can be performed in the patient’s home by a medical professional-usually a nurse. A nurse is able to visit a subject during a clinical trial and conduct aspects of the study in the home, leading to a more community-based clinical trial model. The offer of home visits to undertake some of the study procedures allows the subject to maintain his or her current lifestyle as much as possible. Some benefits of homecare in a healthcare setting include reduction in the frequency of outpatient visits, quicker patient discharge, involving patients in their own care and reduced risk of cross-infection in certain patient groups.

 There is increasing evidence to suggest taking clinical trials to the patient’s home can improve standard of care, patient recruitment, patient retention and, in some cases, decrease costs. This article will look at evidence from patient care and clinical trials, and evaluate if homecare can be a driver of cost savings in a clinical study.
	
	

 (2006) compared, from the patient’s perspective, the delivery of intravenous steroids to multiple sclerosis patients in a home and an outpatient setting. The outpatient group were patients that attended the hospital for treatment without staying overnight. Comparatively, the home group took a supply of the drug home, where a trained home healthcare nurse visited the patient to administer the therapy. These patients were experiencing a disease relapse and required three days of IV steroids in order to control their condition.

 (2015) assessed the efficiency and cost-effectiveness of hospital versus home-based therapy with oral amoxicillin for severe pneumonia in children in developing countries. The study concluded that the cost of hospital treatment compared to home-based therapy was significantly higher, a finding consistent with the recent World Health Organization (WHO) simplified guidelines that state the effectiveness of managing pneumonia at home.

 (2015) reported on the value of home enteral feeding in selected subjects after oesophagectomy or total gastrectomy for cancer. This was found to be feasible, safe, could confer nutritional benefits, and was acceptable to subjects and their caregivers.

 Additional healthcare costs associated with home care in this instance appeared to be neutralized by reduced healthcare costs in other areas.

 Therefore, suggesting homecare during a clinical trial is cost neutral.
	
	The patient dropout rates in longitudinal studies can introduce bias, facilitating subjects returning for follow-up visits and leading to underestimating the number of participants with complications: worse functional outcomes or mortality, e.g., major cardiac or neurologic morbidity and mortality, neurocognitive dysfunction, or functional decline.

 (2012) found 11 additional complications in the homecare group compared to the routine follow-up group. The availability of homecare allowed the inclusion of the complications sustained by these participants in the study results. It is important to note the number of homecare visits required increased for participants over age 75, and patient retention rates were higher in the homecare group. Hence, these could be contributing factors that lead to increased complications being picked up in this group.

 (2016) found that, although homecare had no significant difference on activities of daily life, it did decrease mortality at one and six months in geriatric patients after hospitalization. Homecare can increase safety during vulnerable period after hospital discharge, although further studies are needed.


	
	When considering homecare clinical trials, it is also important to consider the safety of the nurse in the subject’s home. To prevent hazards, the nurse can conduct a full risk assessment during their first visit to the subject.

 (2009) observed a significant improvement in various clinical parameters as well as reduced service utilization (including the number of in-patient days) in patients with cancer receiving oral chemotherapy when a homecare nursing program was implemented. Managing the symptoms at home and nurse-patient relationships could contribute to these improvements.


	
	Chronic obstructive pulmonary disease (COPD) is a common cause of illness and death in many countries.

 (2010) demonstrated the effectiveness of a home-based self-monitoring pulmonary rehabilitation (PR) program (multidisciplinary intervention to care for COPD patients) to be the same as out-patient PR and a valid alternative for the management of COPD patients. Dropout rates dramatically decreased in the homecare group compared to the out-patient group; this is likely due to the fact that carrying out PR at home is logistically easier than traveling to the clinic multiple times a week.


	
	Homecare allows the conduct of clinical trial visits in the subject’s home, decreasing the need to travel to the site. This reduces the burden on patients and the sites, directly increasing patient recruitment and retention.
	
	In a longitudinal randomized controlled study, 

 (2012) found 25% of participants required home visits, which led to a 4% overall dropout rate. Geriatric participants-those with a high medical burden and those with a large number of complications-have a greater risk of dropping out of trials.

 Visits alternated between hospital, outpatient and homecare.

 The post-trial patient assessment yielded the positive outcomes outlined in the below charts.


	
	Providing clinical homecare nursing visits at more than just the traditional homecare level has economic benefits for clinical studies. This article illustrates how clinical homecare can directly affect cost, for example, by bringing the trial to the patient instead of the patient travelling to the study site. Allowing patients to have access to homecare during clinical trials is beneficial to the patient, site and sponsor. Depending on the intensity of the approach, a combination of homecare and outpatient visits can increase standard of care, improve compliance, decrease costs and boost patient recruitment and retention.
	
	

		Sharma, N. “Patient-centric approach for clinical trials: Current trend and new opportunities,” 

		Colquhoun, A. “Clinical homecare providers are warmed up and ready,” 

		Hackett, M. “Homecare medicines – towards a vision for the future” (Department of Health, London, 2011)	

		Patel, A., Bang, A., Singh, M., Dhande, L., Ravi Chelliah, L., Malik, A., Khadse, S., and ISPOT Study Group. “A randomized controlled trial of hospital versus home-based therapy with oral amoxicillin for severe pneumonia in children aged 3 – 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study,” 

		Chataway, J., Porter, B., Riazi, A., Heaney, D., Watt, H., Hobart, J., Thompson, A. “Home versus outpatient administration of intravenous steroids for multiple-sclerosis relapses: a randomised controlled trial,” 

		Bowrey, D., Baker, M., Halliday, V., Thomas, A., Pulikottil-Jacob, R., Smith, K., Morris, T., and Ring, A. “Randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on pilot and feasibility study,” 

		Peterson, J., Pirraglia, P., Wells, M., and Charlson, M. “Attrition in longitudinal randomized controlled trials: home visits make a difference,” 

		Buurman, B., Parlevliet, J., van Deelen, B., de Haan, R., and de Rooji, S. “A randomised clinical trial on a comprehensive geriatric assessment and intensive home follow-up after hospital discharge: The Transitional Care Bridge”, 

		Buurman, B., Parlevliet, J., Allore, H., Blok, W., van Deelen, B., van Charante, E., de Haan, R., and de Rooij, S. “Comprehensive geriatric assessment and transitional care in acutely hospitalized patients: The Transitional Care Bridge randomized clinical trial” 

		Gershon, R., Pogorzelska, M., Qureshi, K., Stone, P., Canton, A., Samar, S., Westra, L., Damsky, M., Sherman, S. “Home health care patients and safety hazards in the home: Preliminary findings,” In: Henriksen K, Battles JB, Keyes MA, Grady ML, eds. 

		Molassiotis, A., Brearley, S., Saunders, M., Craven, O., Wardley, A., Farrell, C., Swindell, R., Todd, C., and Luker, K. “Effectiveness of a home care nursing program in the symptom management of patients with colorectal and breast cancer receiving oral chemotherapy: a randomised, controlled trial,” 

		Mendes de Oliveira, J., Studart Leitão Filho, F., Malosa Sampaio, L., Negrinho de Oliveira, A., Pastrello Hirata, R., Costa, D., Donner, C., V.F. de Oliveira, L. “Outpatient vs. home-based pulmonary rehabilitation in COPD: a randomized controlled trial,” 

		Medical Research Network (2015). Case History 2 – Recruitment. Available at 

		Medical Research Network (2015). Case History 3 – Retention. Available at 

Homecare access to patients participating in clinical trials can prove beneficial for patients, sites and sponsors by incorporating the trial into their everyday lives.