Wednesday, September 28, 2016

Why use home care visits in clinical trials?

by Dr Bettina Bergtholdt, Managing partner at Emovis

Study participation can cause significant burden for patients: the frequency of requested clinic visits is usually high, the time spent at the study site can exceed many hours until all requested data are collected and not to forget the sheer travel time. Even in studies with a patient population suffering from mild diseases, the time consuming aspect of study participation keeps many eligible patients off from taking part in studies.

Recruitment rates and drop-out rates are even more affected by the burden of study participation in the following groups of patients:
  • - Severely ill patients, particularly those with a life-threatening or disabling diagnosis, as clinic visits might become more difficult
  • - Rare diseases, if distances between study site and home of patients are quite far
To avoid low recruitment rates or high drop-out rates in such studies, the concept of home care visits in clinical studies is becoming more and more popular over the last years.

The core idea of home care visits is to provide selected study visits in the home of the patient, performed by a local nurse who is trained on the study specifically for this purpose. Depending on the legal background in different countries, these nurses may perform – as examples, not limited to these – the following tasks:
  • - Body assessment
  • - Vital signs, weight, 
  • - Blood collection and shipment of samples
  • - Supporting the patient with diary entries
  • - Application of Investigational products
  • - Taking photographs of wounds, injection sites, etc. 
The local nurse is part of the study team, by delegation of the Principal Investigator before she starts her duties.

To illustrate the organizational framework, let me describe the processes step-by-step:
  • - Study Site includes a patient in a specific study
  • - Protocol specifies which visits may be performed as home care visits
  • - Ethic Committee and governmental authorities have agreed in advance
  • - Site sends request form to vendor of home care visits, informing about postal code of patient and dates of planned home care visits
  • - Vendor identifies and trains a local nurse (and a back up, if feasible)
  • - Local nurse introduces herself at study site and is being delegated on Authorization Log by Principal Investigator
  • - Vendor provides all necessary material to perform the study tasks to the local nurse
  • - Local nurse visits the patient in his or her home as requested by the site, performing the tasks described in the protocol
  • - Local nurses documents all necessary details on a worksheet. A copy of this worksheet is sent to the vendor for quality control within 24 hours. After quality control the worksheets are forwarded to the site. 
  • - In case of signs or symptoms or any unexpected situation, the nurse informs the site immediately 
  • - The medical responsibility for the patient stays with the site, first of all with the Principal Investigator. 
To give the patient the best benefit possible, the organization of all these steps needs to be performed very carefully and on a professional basis. Frequently various vendors like central labs and couriers in case of blood draws, providers of e-diaries or couriers for (temperature-controlled) IP-delivery are involved and communication between all of them is the most challenging as well as most important aspect for success.

Although management of all these different parties requests high staff capability as well as a good portion of patience and humor, it seems to be worth the investment. After all, patients are very thankful for these services and the possibility to take part in studies which wouldn’t be possible without home care visits.

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