The PP on the other hand concentrated predominantly on fitting the project into its Corporate Design e.
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Four months later May , a social worker with an 0. Public Relations The recruitment process during the Grounded Theory study [10, 11] demonstrated the difficulty of reaching the hidden population of young carers and their families. However, families were waiting for the first support project to start and it was hoped that when they were made aware of the available support they would quickly enroll.
Therefore the RT intended to use the local media to launch the project and disseminate information about the center where young carers might find support. In addition, commercials and flyers were used to spread the information of the upcoming start within the quarter. Unfortunately, the local media totally ignored the press releases, thus the primary method of dissemination was not broadcasted.
As a result, local awareness and knowledge of the project and its intention was very low. Missing Infrastructure It was planned to establish a network of doctors, nurses, youth projects and administrative offices who could refer young carers to the project. But the PP was unknown in the field of youth work and did not have an established network of referral agents. Thus, due to lack of contacts with important partners and to lack of experience with networking, some potential partners identified the project as competition or did not take it seriously.
Therefore at the start of the project hardly any gatekeepers were available.
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Ownership and Crisis In June , it became clear that each team understood the project to be more or less their project, with the other team being just an assistant. For instance, the RT was not 2. As a result, there was no jointly developed project work. Communicating via email and telephone was rather formal and this led to misunderstandings.
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The whole process resulted in frustration on both sides and subsequent conflicts. These were strengthened by the fact that the project was still not well known and therefore no children enrolled in the project by the time it started officially. Finally, a crisis meeting took place at the end of July to resolve these controversial issues. After negotiating the issues, the two parties were able to work together more smoothly and it was hoped that the working morale would improve with recruitment of children for the project. Over the next few months, some mothers called the project leader.
Sample-Size and Design The funders the BMBF wanted strong measurable outcomes rather than action research with qualitative analysis only. The team assumed recruitment would not be problematic. However, after three months, no children had been enrolled in the project, thus the RCT design needed to be reconsidered. At this time October , the original schedule was supposed to have recruited at least 50 children for the project.
This failure to recruit meant the project was in danger of losing its funding. The PP was in contact with eight families, who according to the PP did not fit into the project. Additionally, the RT got copies of all records about every family that had contacted the project so far. 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. The team consisted of three members, each with an 0. Finally, a second crisis meeting was held in February to discuss the controversial issues again. Both partners decided to give the project a last chance.
During the crisis meeting, a mutual consensus about the implementation strategies was reached. As a result, the whole team now acted in concert, with a good working atmosphere and amicable communication, and the implementation process was running - with a total delay of seven months - as intended. In May , a new social worker with an 0.
Since with the new team constellation the project seemed to be on track again, the RT endeavored to get further funding. Finally, the BMBF awarded a grant extension until end of Summing up, it took seven months to get the first child into the project March Currently November , sixteen months after the official start , eight children have been enrolled.
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The problems during the implementation process can be assigned to the following four main shortcomings: No Insistence on Guidance At the beginning, the RT had huge problems finding a PP. Accepting RCT design 2. No insistence on guidance 3. 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: 4.
No pilot on recruitment a give overall guidance, Accepting RCT Design b be involved in the decision-making process on-site, RCTs are still widely accepted as the gold standard for evaluating health-care interventions  and decisionmakers are increasingly looking to the results of RCT studies as a practice guide. 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. 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.
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. The RT feared the rejection of the proposal if it contained a good deal of action research.
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.
Having such external supervision can prevent the genesis of interpersonal conflicts within empirical social research. 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 , the project had low awareness within this network, and some projects even identified it either as a rival or as superfluous. 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 .
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. 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 confidencebuilding as the first priority in order to be able to reach those families in need. 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. 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.