Multidimensional assessment of infant, parent and staff outcomes during a family centered care enhancement project in a tertiary neonatal intensive care unit: study protocol of a longitudinal cohort study

Family centred care (FCC) acknowledges that emotional, social and developmental support are integral components of health care. The respect for the infants’ and the families’ innate strengths are at the core of FCC as well as supporting families in their caregiving and decision-making roles [1]. In 1993 Helen Harrison introduced the principles of FCC in the Neonatal Intensive Care Unit (NICU) [2]. Since that time various FCC initiatives have been implemented, although inconsistently, in NICUs all over the world [3‐5].

FCC is more of a concept that needs to be integrated into the culture of the NICU and the attitude of each individual than a set of tasks to be accomplished [6, 7] At the core of FCC is providing healthcare in the context of the strengths and needs of the patients, their family and the community. The goal is to improve quality, psychological wellbeing, clinical outcomes and the overall patient and family experience [6].

Technical and medical advances greatly improved the outcome of preterm infants, especially for the most immature, [8] but NICUs are highly professionalized and often stressful environments for preterm infants and their parents [9]. In spite of these advances neonatal morbidities (e.g. bronchopulmonary dysplasia, retinopathy of prematurity, severe brain injury) continue to affect premature infants and they still have more neurobehavioral problems and a poorer neurodevelopmental outcome than their term counterparts [10, 11]. The stressful NICU environment and the stressful experience of the parents might further aggravate these undesirable outcomes. FCC has been introduced into the care of preterm infants to reduce stress for the infant and the whole family.

FCC interventions and outcomes vary significantly across different studies [12]. Parents were involved in the care to different degrees, ranging from interventions to support parents, interventions that are delivered by parents to concepts that focus on partnering with parents as equal counterparts in the care of their infant [6]. In a recent review FCC interventions improved weight gain, readmission rates and parental satisfaction, however, length of stay and neonatal morbidities were not improved [12]. Family integrated care (FiCare) has been developed in Canada and is currently the FCC programme that has been tested in the largest group of preterm infants with improved infant weight gain and motor development and reduced parental anxiety [12‐14]. FiCare is built on four pillars: Parent education, staff education, NICU environment and psychosocial support: [13].

The present study will focus on interventions following the 4 pillar concept.

The primary outcome of the study is length of hospital stay measured by corrected gestational age at discharge. We hypothesize that empowerment of parents and their increasingly active involvement in infant care will reduce length of hospital stay, as parents will be ready to take their infant home earlier [15].

Quality improvement (QI) methods have become a central part of neonatology within the last years. One widely used approach is the Model for Improvement and the PDSA (Plan- Do- Study- Act) cycle (Model for Improvement, Fig. 1) [16].

The Model of Improvement asks three questions: What are we trying to accomplish? (aim) How will we know that a change is an improvement? (measurement) What change can we make that will result in improvement? (wise guess) [16].

The PDSA cycle is a continuous circuit of sequential cycles with the complexity and size of cycles increasing with every cycle [17]. The cycle starts with a change concept (Plan), the next step is the implementation of the new intervention (Do), followed by qualitative and quantitative monitoring and data collection (Study) and the final step of integrating the learning generated which will then lead to acceptance, rejection or adaptation of the intervention (Act), [16] followed by the next PDSA cycle (PDSA cycles, Fig. 2).

Although widely used in healthcare two reviews of 2014 and 2019 have shown that the five key principles of the PDSA cycle are applied inconsistently with only 3% and 4% of the reviewed studies applying all of the following key principles: sufficient documentation of PDSA cycles, iterative cycles, small-scale-testing, continuous data collection and theoretical rationale [17, 18]. Consistent improvements require iterative adaptation to the local context therefore greater scientific rigour is needed in the application and reporting of these methods [18].

Despite the challenges in its most effective application, PDSA cycles have been used successfully [19‐21]. The strength of the PDSA cycle is the iterative approach to test and assess an intervention rapidly and make necessary changes timely [18]. The present study will use the Model for Improvement and the PDSA cycle to improve FCC in our level III NICU.

An urgent need is seen to standardize FCC interventions and core outcome measures to enable future comparison of the efficiency of FCC interventions and thus to improve the evidence base [12]. These outcome measures need to involve the infant, the parents and the medical team, as all are closely linked and interdependent.

Therefore, a comprehensive standardized assessment tool assessing the advances of parent, infant and staff outcome in the context of the degree of FCC implementation was developed. The aim of the present study is to test this new assessment tool in a prospective single centre longitudinal cohort study.

The study design is a prospective single centre longitudinal cohort study as the enhancement of FCC primarily is a change in unit culture and the attitudes of individuals [7].

The current project aims to enhance FCC in a level III NICU in Gießen, Germany. The FINE (Family Infant Neurodevelopmental Education) education in FCC has been introduced as baseline but FCC depends on repetitive evaluation, propagation of its aims and stepwise implementation of further focus fields. The study continuously assesses whether the implemented changes to advance FCC improve FCC indicators and multidimensional outcomes. Infant, parents and staff outcomes are evaluated separately and interactions between these three dimensions will be analyzed as well. To our best knowledge, this is the first study systematically assessing the further enhancement of FCC in such a comprehensive way. A particular strength is that all data will be recorded separately for mothers and fathers. Although fathers have become more involved in the care of their preterm children only few studies have focused on the visiting patterns, involvement and well-being of fathers [40‐43]. This study will provide further insight and can help to better support fathers of preterm infants.

Data on measurable indicators showing an increase of parental participation in the care of their preterm infant as a result of FCC interventions is scarce [43]. The standardized assessment tool and the CO-PARTNER tool will thoroughly document parental participation in several areas (kangarooing, visit time, different caregiving activities like bottle feed/breastfeeding, diaper change…) through charts at the bedside to be able to assess whether FCC interventions have an impact on parental skills.

Several professional societies endorse FCC by policy statements [1]. Although these policy statements exist, the practical implementation is varying across different countries, but also within countries [4, 5]. Disseminating innovations in health care is challenging with a considerable gap between knowledge and practice. To make change happen it is not enough that evidence for an intervention is available. The more difficult part is to translate evidence into local clinical practice [44]. To facilitate positive change management, a multidisciplinary team including nurses and physicians was implemented in the first stage with the aim to complement the team with parents of former preterm infants. This team consists of staff members with a special interest or expertise in FCC and will lead the process of innovation adjusted to the local neonatology department [45]. A multidisciplinary focus group was chosen to guide the implementation as successful dissemination of innovations in health care that is best achieved if a clinical guideline or recommendation is not merely repeated, but reinvented by the team and adjusted to the local context [19, 44]. The EPICE (Effective Perinatal Intensive Care in Europe) study group has identified the following three crucial factors for making change in the NICU happen: Innovation ideas that come from the NICU team itself and not from outside, active participation of the unit staff in the development and implementation of the innovation or policy change and the presence of staff members with personal interest in making the change happen [45].

FCC has been described as a journey with different neonatal units at different stages [46]. We have started on this journey four years ago and want to move further along the way.

QI efforts in healthcare have demonstrated variable results, some reporting positive changes in patient outcomes, others reporting no changes [20, 47, 48]. One possible reason for this variability is that e.g. the PDSA cycle has not been implemented rigorously in many studies [17, 18]. If implemented well, the PDSA cycle has the potential to lead to sustained improvement in healthcare and enable stepwise assessments and timely intervention [20]. Therefore, it is reasonable to not discard the method as such, but diligently apply the method. We will thoroughly consider the five key elements of the PDSA cycle identified as crucial by Taylor and Knudsen [17, 18]. The reporting will be done according to the SQUIRE 2.0 publication guidelines to ensure completeness, precision and transparency [49].

Changing the culture of a unit and the attitudes of individuals is challenging [7] and it is a very sensitive process. Acknowledging this Quality Improvement (QI) project as such a sensitive process we will evaluate staff satisfaction regularly. The implementation of changes often leads to an initial decline in staff satisfaction, followed by a recovery [50]. The scheduled 6 monthly assessment of staff satisfaction will enable us to realize early whether after an expected initial decline staff satisfaction recovers again.

This study will provide important insight into the application of a QI method to advance FCC in a NICU regarding the success of the QI method in achieving a higher degree of FCC and regarding team satisfaction during this change process.

Moreover statistical process control methods will be used as a novel approach to prospectively analyse the data over time and to understand and address the performance of the QI project [39]. This technique enables clinicians to detect process changes and trends earlier with the help of graphical display [51]. This approach has been suggested as a beneficial tool in neonatology [39, 47, 52]. The Canadian Neonatal Network recently published the results of a quality improvement initiative after a period of 14 years of experience using this technique [38]. Naturally, clinical data has some variation over time that is independent of interventions. Process control charts help to distinguish between natural variation and variation due to specific interventions.

The COVID pandemic starting at the beginning of our study was a big challenge as access to hospitals was greatly restricted in Germany also for the parents of NICU patients. Our results might give further insight into the consequences of these restrictions for the infant, parents and staff.

There are as well limitations to our study. The study is a single centre study undertaken in one neonatology department in Germany. The context of the particular neonatology department involved and its patient demographics including the socioeconomic and cultural background will influence the results. Due to the single center design the number of patients is restricted and a recruitment period of 5.5 years is needed. Changes of e.g. nurse-patient ratios on the basis of modifications of the obligatory national guideline of the Joint National Committee of Germany or towards the provision of active support according to the national AWMF guideline recommendations for the care of preterm infants at the border of viability will have an impact on the study results. Possible demographic changes over the study duration will also affect results. Nevertheless, our study pioneers the comprehensive evaluation of infant, parental and staff outcomes and when implemented successfully, the studied comprehensive assessment tool can be used to monitor and guide FCC interventions within a local or multicentre context in any other NICU.