Background: A significant potential for patient empowerment is seen in concepts aiming to give patients access to their personal health information (PHI) and to share this PHI across different care settings and health systems. Personal health records (PHRs) and the availability of information through health information exchanges are considered to be key components of effective and efficient health care. With tethered PHRs, as often used in the United States, patients' opportunities to manage their PHI are strongly restricted. Therefore, within the INFOPAT (information technology for patient oriented care) project (2012-2016) in Germany, funded by the Federal Ministry of Education and Research (BMBF), the development of a patient-controlled "personal electronic health record" (PEPA) was based on user requirements right from the beginning.
Objective: The overall objective of the study is to implement and evaluate a PEPA prototype for patients with colorectal cancer who are treated at the National Center for Tumor Diseases in Heidelberg. To achieve this aim, this study has 2 parts: a pre-implementation study (phase 1) and an implementation study (phase 2). The pre-implementation study will include a usability evaluation of the PEPA approach and the consideration of organizational preconditions for the implementation. With the implementation study, we will evaluate the process of implementation (eg, barriers or facilitators), the need for organizational change (eg, processes of communication), and the impact on outcomes (eg, self-efficacy, involvement in care).
Methods: The pre-implementation study is based on a mixed methods approach and comprises qualitative and quantitative element according to our research aim. We will use a think-aloud method for the usability analysis. Additionally, participants will be asked to evaluate their overall satisfaction based on a standardized questionnaire, the System Usability Scale. For the analysis of preconditions, we will conduct semistructured personal interviews with, for example, patients, medical assistants, and physicians. Within the implementation study the outcome evaluation is planned as a prospective, 3-month, open-label "before and after" trial. Additionally, for the analysis of processes and the need for organizational change, we will conduct interviews with the participants (eg, patients, general practitioners, physicians) of the before and after trial.
Results: This project is part of the INFOPAT project, which is funded (2012-2016) by the Federal Ministry of Education and Research (BMBF). The enrolment was completed in July 2016. Data analysis is currently under way and the first results are expected to be submitted for publication at end of 2017.
Conclusions: Existing approaches of PHRs aim to give patients access to their treatment data. With the PEPA approach and this study, we go a step further: patients have access to their PHI and they can give other persons (eg, their general practitioner) access. With this approach, new possibilities for professional collaboration and the engagement of patients can arise.
Keywords: chronic care; colorectal cancer; feasibility studies; interprofessional collaboration; personal electronic health record; self-efficacy; telemedicine.
©Dominik Ose, Aline Kunz, Sabrina Pohlmann, Helene Hofmann, Markus Qreini, Johannes Krisam, Lorenz Uhlmann, Christian Jacke, Eva C Winkler, Hans-Joachim Salize, Joachim Szecsenyi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.03.2017.