Aims and objectives

The planned study is part of the interdisciplinary public health research consortium HELICAP (“Health literacy in early childhood allergy prevention”). HELICAP, funded by the German Research Foundation for a period of six years, assesses ECAP from a public health perspective, for instance regarding how health professionals communicate evidence to parents, and to what extent mothers and fathers behave in a health-literate way during pregnancy and early childhood [20, 21].

In this study protocol, we describe how this planned study will aim to understand how health and social care institutions communicate ECAP information to parents, and what factors facilitate or hinder this process. The specific research objectives are to 1) assess which local and regional health and social care agencies are available to deliver ECAP information, and their respective barriers, facilitators and preferences for implementation (pre-implementation analysis); 2) develop an implementation strategy and test the provision of ECAP information in health and social care settings (implementation planning and implementation) – specified for different groups of parents according to socio-cultural backgrounds; and 3) evaluate implementation outcomes from the perspective of ECAP information providers and recipients (evaluation).

Study design and conceptual framework

Overall, the planned study entails six steps related to planning, conducting and evaluating the implementation process, structured according to the Implementation Research Logic Model (IRLM) by Smith, Li and Rafferty (2020) [22]. The IRLM integrates central components of evidence-based implementation research, including implementation determinants (constituted by the Consolidated Framework of Implementation Research, CFIR) [23], implementation strategies [24] and implementation outcomes, and therefore provides crucial guidance throughout the process [25, 26] (Fig. 1).

Fig. 1

Implementation Research Logic Model adjusted for this study

Besides this theoretical guidance, a panel/board consisting of parents of young children will inform various steps of this research project. This will be carried out according to the principles and steps outlined by one of the major German manuals for participatory health research [27]. To select panel members, we will approach parents who were previously part of a similar board in the project that preceded this study [28]. We plan to have a panel of n = 5–7 members to allow for spontaneous unavailability of individual members, given parents’ high involvement in family and work duties. To keep participation for panel members feasible and attractive, we will suggest two meetings and two opportunities for providing written feedback per year. We will therefore define relevant feedback phases, e.g. to develop interview contents, decide on the selection of institutions, and to pre-test the ECAP information. As panel members will be recruited from different locations, meetings will be held primarily online [29].

Below, we describe each of the following steps: 1) Mapping health and social care providers at regional and local level that currently provide ECAP information services to parents, 2) Assessing implementation facilitators and barriers from the mapped actors, 3) establishing a patient and public involvement group to advise the development and testing of a process to provide ECAP information to parents, 4), Developing exemplary ECAP information materials for distinct parent groups, 5) Initiating a phase of ECAP information provision, 6) Collecting and analyzing quantitative and qualitative implementation outcomes data.

Assessment of implementation determinantsPart a: Mapping ECAP information providers

As outlined above, several on-site actors and institutions in health and social care may implicitly or explicitly provide ECAP information to parents. Therefore, it is necessary to understand who they are, and how providing ECAP information is part of their role. Mapping provides the basis for approaching health and social care providers for the subsequent steps of planning, realizing and evaluating the implementation.

Data collection

Hannover in the north will serve as a model region for the mapping and will be complemented by two additional regions for comparison, Magdeburg in the east and Regensburg in the south, locations of other parts of the HELICAP consortium. The above-mentioned Public Health actors mapping by Hommes et al. (2021) provides the methodological basis for the subsequent steps [19]. Firstly, we will develop and agree on a preliminary set of search terms according to the Population-Intervention-Context-Outcome (PICO) logic (Table 1) [30]. The PICO scheme systematically addresses each of the items necessary to formulate a research question, i.e. to define a comprehensive search term for a bibliographic search. This will be done together with the parent panel and the scientific advisory board accompanying the project consortium (see Methods).

Table 1 Preliminary search terms according to the “Population-Intervention-Context-Outcome” scheme

Based on the final version, we will conduct a full digital search for regional and local institutions via Google, as this is the most common (digital) way for parents to search for health information [9]. For each full search term, two researchers will independently screen the first 100 results using inclusion and exclusion criteria. We will include those institutions/actors that provide:

health and/or social care for children, including disease prevention, whether general or specific to allergies,

information on child health to parents, either as part of the actor’s professional role of providing services to parents, or as part of a voluntary service, e.g. in the case of parents running a network, group, or initiative to advise other parents.

Correspondingly, we will exclude those that:

are located outside the above specified regions,

have no regular direct contact with parents,

have no resources/working structures related to providing health information to parents,

offer no information/consultation related to disease prevention.

We will then complete the findings using the snowball approach [31]. Firstly, websites of all included institutions will be screened for mentioned partners and collaborators who fulfil the inclusion criteria. Further, we will present the preliminary list to a conveniently selected group of regional and local public health and health care experts in the Hannover region as well as to the parents’ panel, for suggestions of further relevant actors. This step focusses on identifying parental health information providers/channels that may not be immediately identified through a formal search, but that nevertheless play a relevant role in communicating with parents about child health, e.g. “Neighbourhood Mothers”.

Analysis

To structure the included sources, we will inductively assign each included actor to an overarching thematic category, based on their website’s description. According to the preferences for receiving ECAP information mentioned by parents in our previous work on this topic, categories could broadly relate to formal institutions such as a) health professionals specializing in child care and women’s health, b) family centers (childcare), c) community, civil and welfare services, and d) insurers; informal actors such as e) individuals and groups counselling/consulting other parents about child health (online and offline); f) associations/clubs run by volunteers offering exchange among parents; and g) voluntary workers.

Part b: Exploration of implementation barriers and facilitators

Once a map of ECAP information providers is available, the pre-implementation assessment dictates the exploration of determinants that may facilitate or hinder the provision of ECAP information to parents. According to the CFIR, these relate to an institution’s outer setting (e.g. external regulations that ease or hinder health information provision), inner setting (e.g. available resources) and characteristics of individuals (e.g. feeling capable of providing health information) within an institution. Hence, a qualitative approach is required to gain an in-depth understanding.

Participants

We aim to conduct semi-structured interviews with health and social care providers from each mapping category, to cover the diversity of perspectives. Using the retrieved contacts from each included actor, we will approach them one at a time until n = 2 respondents from each category have agreed to participate (ca. n = 10–15 interviews in total). Contacts will be established, firstly, via email and, subsequently, by phone. We will follow a recruitment approach that takes the perspective of potential study participants [32]. Accordingly, we will for instance invite umbrella organizations of the local health and social care providers to assist the recruitment process, to increase awareness of and trust in the study.

Data collection

Interview questions will be derived from the CFIR determinants, with a focus on aspects relevant prior to implementation, e.g. “relative priority”: “how important is it for you to provide ECAP information in your institution?”; “incentive systems”: “what kind of incentive would be necessary for you and for your clients to consider ECAP counselling/information?” The CFIR interview guide tool serves to draft a first set of questions, which will be reviewed and finalized by consulting experts from public health and implementation science who are associated with this study. The interviews should last 30–45 min and will be conducted according to the interviewees’ preference either via telephone, video call, or on-site. The project staff has experience in collecting qualitative data from several previous projects, e.g. [33].

Data analysis

The interview transcripts will be imported into MAXQDA for qualitative content analysis according to Kuckartz [34]: In phase 1, two researchers will analyse n = 3 transcripts together using the CFIR codebook template and will adapt the preliminary list of codes according to the interview contents. In phase 2, two researchers will independently code the transcripts in full and identify any unclear text passages. These, as well as conflicts regarding coding, will be discussed and resolved in bilateral meetings between the researchers, in order to reach an inter-coder agreement. In phase 3, we will produce qualitative summaries for each CFIR subcategory included in the interviews and rate the determinants as barriers or facilitators using ratings described in [22].

Data Integrity

Several measures will contribute to improving the research rigour for the qualitative phase of this study, i.e. the interviews: the use of a multi-coder approach and the ongoing comparison of the results will enhance the credibility of the analysis; the consistent application of the research methodology will ensure dependability; the review and discussion of the decisions that will be made during the research process in bilateral meetings will help to increase the confirmability. In addition, we will apply member checking for the coded text passages, meaning the interviewees will be asked to provide feedback on the analysis. We will initially do this for 20% of the analysed material to ensure feasibility, and ask for feedback on the remaining materials if this appears necessary.