It was planned to initiate the project in a city not far away from the research team (RT), which is located in one of the biggest metropolitan areas in Germany. As the BMBF’s grant was limited to financing the scientific staff (including development and evaluation of the concept as well as the scientific manpower), the RT sought a partner (PP) who was willing to implement and fund the practical part of this project. The RT presented its findings at several conferences and conducted a symposium where the concept was presented and discussed. The RT was to act as consultants to the practice partners who were to implement the intervention. The RT was also responsible for undertaking the evaluation. The Grounded Theory study [10, 11], on which this intervention had been founded, had a high profile in the media and attracted a lot of interest among local practice partners. Due to the upcoming economic recession, all potential PPs were unable to fund the project and finally withdrew their interest. It took the RT seven months to finally find a PP in another city about 400 km away. The official start of co-operation was December 2008.

The PP is an old, well-established, hierarchically structured organization, which is used to acting independently. The PP’s motivation to implement a young carers project was to realign their social engagement in their neighborhood, and they also found it attractive to be the first to take care of this vulnerable population in Germany. Until then, their main sphere of activity was traditional nursing care and nurse’s education.

The RT and PP agreed to work as a team with different responsibilities: the RT was responsible for scientific leadership and the PP for the practical implementation. Due to the distance of 400 km between the two partners, we decided to primarily communicate via email and telephone, with bi-monthly face-to-face meetings.

In 2009, the whole team was enthusiastic about starting the project. The PP decided to take six months for necessary preparatory work, like getting rooms which are suitable for children, recruiting staff, creating a logo, website and information flyers. Thus the official start was rescheduled - which led to a delay of six months compared to the original research schedule.

The RT analyzed the interviews and case-files. The RT learned from the interviews that there was a lack of communication and guidance between the leader and two team members and that this had adversely affected recruitment for the study. The latter had poor knowledge about the concept which resulted in uncertainty concerning work assignments and unfocused project work. Case file analysis confirmed that two families, whose children fitted the criterion for inclusion into the project, had been sent to other social projects by the PP.

RCTs are still widely accepted as the gold standard for evaluating health-care interventions [18] and decision-makers are increasingly looking to the results of RCT studies as a practice guide. The project’s intervention is - as most nursing interventions are - a complex intervention (1; 19), and there is an ongoing discussion whether RCTs are preferable and appropriate for their evaluation at all [1, 3, 19]. Nevertheless, several guidelines have been published on how to develop, implement and evaluate complex nursing interventions [20, 21], and all of them state that the study design should be chosen on the basis of the study’s specific characteristics, RCTs included.

When the study was conceived, the RT based the whole process on the Utrecht Model [21, 22], which also states that an RCT should be conducted if necessary and ethical justifiable. However, the model also states that a field phase should be conducted prior to the RCT, which is predominantly linked to action research. This phase aims on piloting the intervention until no further modification is indicated.

When the study’s application form was sent to the BMBF, the RT proposed a qualitative approach, which combined both the field and evaluation phase. The BMBF advised to state precisely a specific outcome criterion which the intervention should focus on. In addition, the RT was advised to name an adequate design in order to evaluate this specific outcome criterion rather than conducting action research. In order to get funding for the study, the RT changed the design to an RCT despite better knowledge. The RT also skipped the field phase during the re-conception of the study’s schedule because of three reasons:

1. The generally granted running time was limited to three years, leaving the RT no time for an adequate field phase
2. The RT was confident that the concept was cogent enough to be tested directly. Minor adjustments were planned to be carried out after the RCT phase.
3. The RT feared the rejection of the proposal if it contained a good deal of action research.

At the beginning, the RT had huge problems finding a PP. At the time when the current PP decided to co-operate, there was already a delay of three months within the granted research schedule, and the RT was to a certain degree reliant on the PP’s participation. For this reason, the RT let the PP act independently concerning decision-making on-site rather then insisting on adherence to the study’s strict schedule. For instance, the PP’s decision to set the official start at July 2009 led to a further delay in the RT’s study schedule.

The RT did not control the PP’s understanding and interpretation of the concept, as the PP appeared to be well-informed and able to act independently. Therefore the PP was more or less free in its decision-making concerning the preparation and management of the implementation process, and the RT failed to:

1. give overall guidance,
2. be involved in the decision-making process on-site,
3. have a say concerning application procedures of new team members,
4. instruct new team members, and to
5. have the final say.

Due to this delegation of responsibility the RT was slow to realize that the project implementation was not progressing in the intended direction. The spatial distance between the RT and the PP exacerbated this loss of control. The problems concerning the relationship between the PP and the RT were of an interpersonal nature, and thus they were not predictable. Nevertheless, these difficulties could have been identified in the early stage if the whole process had been subject to analysis and reflection while it was being carried out. For example, in qualitative research, it is good practice to have an external person, who is not involved in the project and who helps with reflection and analysis of the whole process during the study’s entire running time. Having such external supervision can prevent the genesis of interpersonal conflicts within empirical social research.

The RT did no feasibility piloting. As the project needed to be set up from scratch with a completely new team, there was no need to test whether the intervention would fit into existing work proceedings. What at least should have been piloted was how the project could be installed as a part of the local social and health-care services network. Due to inexperienced networking in 2009, the project had low awareness within this network, and some projects even identified it either as a rival or as superfluous. It was a fortunate coincidence that the PP’s new project leader not only had experience in networking but also had personal contacts to important established projects as well as to administrative offices.

The main aim of the project is of course the support of young carers and their families, but on the other hand, the RT was dependent on a high number of participants in order to carry out a RCT to evaluate the intervention’s effectiveness.

Therefore, the RT’s first priority was to recruit children for the project in order to reach the calculated sample size. It is known from the literature that recruitment often takes more time or is more difficult than expected, with many trials failing to reach their sample size within the granted timescale [23]. Although the RT had experience with the difficulties of reaching the very hidden population of young carers, they totally underestimated the obstacles of enlisting suitable children for the project. This was due to the results of the Grounded Theory study, which stated that the families concerned were waiting for the first support project to start. On the basis of these findings, RT predicted that children would readily enroll in the project.

One characteristic of the population under study is its concealment. During the Grounded Theory study’s interviews, the informants were in a protected and self-imposed conversation, and they became more and more familiar with the interviewer. It could be due to this confidence that nearly all of them stated they would enroll in a young carers’ project if it were available.

For a new project, it is far more difficult to earn confidence from a cautious population.

Therefore, as an overall strategy, support needs to be organized through an outreach program with confidence-building as the first priority in order to be able to reach those families in need. It is arguable whether the project’s recruitment strategies were in concert with an outreach strategy.

The label “out reach program” implicates that the project’s services need to be offered directly to the families concerned. Therefore, the project must try to reach them at places where they spent time socially.

With regard to the children, convenient places could be schools or youth centers. The project staff could have consultation hours at fixed dates, maintaining a presence and spreading information. This ongoing presence could increase confidence, and it might enhance the chance that a young carer calls on the project’s service.

With regard to the parents, convenient places could be hospitals or doctor’s practices. If a parent with a chronic illness is treated there, general information about the project could also be supplied. After giving the parents some time to reflect, an initial contact with the project could be offered. However, using the network as gatekeepers requires network partners who remember the project and who introduce its services to the clients at the right time.

Nevertheless, in pursuing these strategies, there is still a need for piloting recruitment in order to get an overview on how many families can be put in touch with the project in the required time-frame. This would answer the question of whether conducting an RCT with a given sample size in a given time is realistically feasible at all.

This emphasizes the necessity of conducting a field phase before running an RCT that already has a given sample size and time-frame, especially within a hidden population. It could have saved time and money if the RT would had followed all phases of the Utrecht Model, which puts emphasis on a field phase in which the intervention is tested and modified before running a quantitative evaluation study.

It is difficult to persuade health-care providers to recognize new problems and it takes an even longer time until they realize they have a responsibility to act. The RT totally underestimated the persuasive powers which are necessary to find a suitable PP. Additionally, when an interested provider is found, one should at least keep in mind that the PPs are likely to have specific reasons, even a hidden agenda, for implementing new interventions in new areas, and these might be very different to the RT’s intentions.

The population of young carers is hidden, unknown and probably underestimated [8, 10, 24, 25]. Reaching this hidden group in one study (Grounded Theory study) does not necessarily mean that this will succeed again in another study or intervention (current study). The implication of this is that any project or research targeting such a group must add in extra time in their calculations for contacting and recruiting members of this population.

The RT chose the Utrecht Model as a guideline for the implementation and evaluation process. As described above, the RT decided to skip the model’s field phase despite better knowledge. However, a major part of the above described implementation problems are topics related to this specific phase. One could say that although the phase was skipped, it claims its time and space anyhow. The model’s authors apparently have good reasons for including such a phase in their guideline. If researchers choose such a model, they should adhere to it completely.

When the study was initially planned, it was intended to use a qualitative approach. Following the BMBF’s feedback, these plans had to be changed. Adhering to the paradigm of evidence-based health-care, the reviewers argued for the application of a “gold-standard” approach. Although this recommendation is in concert with the current economic zeitgeist concerning efficacy, it lacked the reflection of the study’s original interests.

Blumer (1998) states that “such conceptions are a travesty on methodology as the logical study of the principles underlying the conduct of scientific inquiry” [26, p. 24].

We would even add that following the evidence-based paradigm in an unreflective way is the end of any serious methodological legitimization.

However, due to the failure of recruiting the calculated sample size, the funded RCT study had to revert to a qualitative design in accordance with the BMBF.