Piloting and evaluating feasibility of a training program to improve patient safety for inter-professional inpatient care teams – study protocol of a cluster randomized controlled trial

Improving patient safety is a major goal in healthcare systems worldwide [1]. Patient safety can be defined as the “avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare” [2]. The World Health Organization has stated that 134 million adverse events occur each year in hospitals, contributing to 2.6 million deaths annually due to unsafe care [3]. Internationally, a wide range of interventions for improving patient safety exist, putting a particular emphasis on developing training programs [4]. Existing international training programs often focus on single professions as well as a specific patient safety topic, e.g., teamwork (Strategies and Tools to Enhance Performance and Patient Safety – TeamSTEPPS, USA) [5, 6], Speak up initiatives (USA) [7‐9], patient involvement (Patientenempfehlungen (Recommendations for patients) – PATEM, Switzerland) [10]. To the best of our knowledge, there is no inter-professional training program for inpatient care teams which covers different key areas of patient safety. However, due to the complexity of patient safety, a reduction to the most important contents was necessary. Therefore, focus groups were established by our research group to find out the requirements of an inter-professional, multi-content, training program in Germany [11]. The main findings of the study were the training format and recommendations regarding the content: The training should be a combination of e-learning and interactive in-person training (blended learning), with the content focused on Teamwork, Error management and Patient involvement [11]. These recommendations are consistent with the Patient Safety Curriculum Guide [1] and the Learning Objective Catalog for Patient Safety [12], which define these as the three key areas, among others. If we look into the literature, a considerable amount of evidence can be found confirming these topics as the three key areas. Current research shows that training programs can provide new insights and improve attitudes toward teamwork [13‐17]. Improving teamwork can lead to increased patient satisfaction [18], employee satisfaction [19] and employee well-being [20], more efficient patient treatment [21] as well as to decreased medical errors [22] and mortality [23]. By improving communication within the team of healthcare professionals and with patients, such programs can also contribute to improvements in healthcare delivery and make healthcare safer [17, 24‐31]. Furthermore, discussions and reflections of adverse events, errors and their consequences for patients can build the foundation for open communication and thus a practiced safety culture [32]. With regard to patient involvement, patients have been found to possess the willingness, ability and desire to play an active role in error prevention in accordance with their capabilities [28, 33‐36]. However, this willingness is closely linked to positive attitudes of the inpatient care team concerning open communication about errors and patient involvement as well as to their social and communicative competencies [37‐39]. In total, all three topics are mutually dependent on each other and lead to better patient safety.

The KOMPAS project (KOMPAS = German acronym for “Development and evaluation of a complex training program to improve patient safety”) takes a first step to close this gap by designing a training program according to the stated criteria by using innovative adult education methods. Moreover, an optimal implementation strategy can foster the implementation of the intervention in healthcare practice by overcoming potential barriers. The present study aims to (1) pilot the training program by comparing two different training formats with a waiting control group (WCG) and (2) evaluate the feasibility of this intervention.

The study puts forth a training intervention which has the potential to improve patient safety in inpatient care. Members of inpatient care teams will be trained in three key areas, which are crucial for patient safety, simultaneously. We expect the intervention to establish a standardized and quality-assured format for the training of basic competencies in Teamwork, Error management and Patient involvement. In doing so, the intervention will contribute to improving Safety-related behavior as well as Subjectively perceived patient safety by inpatient care teams. The inter-professional design of the intervention will serve to encourage exchange between the different professions in addition to establishing a shared knowledge base [69]. The blended learning format will support application of the theoretical knowledge gained, thereby facilitating the transfer into routine clinical practice.

Despite the fact that we will conduct a multicenter study, which enables a higher degree of generalization, it must be critically noted that there is a risk for selection bias in recruitment, which might narrow the external validity of the study. Possibly, hospitals and wards which choose to participate are primarily those which are prone to interventions of this type and content. Moreover, it is possible that the exclusion of pediatric, emergency, and intensive care units could narrow the generalization of the results. Furthermore, the fact that the situational judgement tests have not been validated yet, imposes a methodological limitation on the study. Future studies should establish the validity of the tools used for the specific context. Another limitation of the study are the three points of assessment. We cannot rule out that there are dropouts. That is why we assumed a high dropout rate from the beginning.

Based on former studies on interventions of patient safety [13‐17], it can be assumed that the training will have great potential for the results to be used in future research and practice. The present study will provide the basis for a confirmatory phase-3 study [40]. Furthermore, the results of problem-focused individual interviews and the developed strategies for overcoming potential barriers could be used for deriving a set of implementation guidelines in healthcare. In addition, approaches for improving the e-learning course and in-person training will be developed where required in order to maximize acceptance among the participants.

In future research, the training could be offered at other hospitals. The training program could also be adapted and evaluated for the education sector and other areas of healthcare. Using a train the trainer concept, internal trainers (e.g., quality managers, human resource staff members) could be trained to perform the in-person training. Consequently, the intervention could be used continuously and comprehensively to provide advanced training for hospital staff. Moreover, it opens up the possibility of designing and specializing in a wide range of directions (e.g., tandem/team teaching, indication-specific modules).

Recruiting is in process (issue date 12 December 2018). Participating hospitals and wards have been provided with necessary information on intervention and data collection. Pre-data collection started in July 2018 and will probably be completed in spring 2019.

The findings of the study will be communicated using a comprehensive dissemination strategy. Peer-reviewed publications are planned under corporate authorship of the KOMPAS research team. Moreover, presentations of study findings will also be taken to relevant national and international research conferences, congresses and local research symposia. Results will also be disseminated to the participating wards. Moreover, results from problem-focused interviews as well as strategies for overcoming barriers will be made publicly available to create transparency for persons in charge for the implementation of the intervention in the future.

Important protocol modifications will be reported to relevant parties (e.g., trial registries, Ethics Committee, journals) immediately.