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To address these issues a new service delivery model has been put in place, implemented in three AAC counselling centres for patients with a particular health insurance across Germany. The implementation of a new service delivery model aims to improve individualised service delivery. The model goes beyond standard care by adding case management, counselling, AAC training and, if needed, AAC therapy. This study aims to evaluate the effectiveness of this complex intervention.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>In consideration of the complexity of the new service delivery model, formative and summative evaluation will be conducted. The formative evaluation will provide data based on qualitative and quantitative assessments of the competences and perspectives of all involved stakeholders, including a proxy measurement of persons with CCN. The summative evaluation will include a controlled study design as the new service delivery model will be compared against the service delivery in an existing contract and against data gathered from caregivers of AAC users provided with standard care. With the exception of the individual interviews the data will be collected from proxies\u2014that is, informal and formal caregivers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>Data collection, storage and evaluation meet the currently valid data protection regulations. Consultation by the responsible data protection officer of the Oldenburg Medical School and a positive vote from its Ethics Committee were obtained prior to the start of the study. Dissemination strategies include the presentation of the obtained data and results in the form of publications and at conferences.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>DRKS00013628.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2019-029469","type":"journal-article","created":{"date-parts":[[2019,8,29]],"date-time":"2019-08-29T11:44:47Z","timestamp":1567079087000},"page":"e029469","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Complex intervention in augmentative and alternative communication (AAC) care in Germany: a study protocol of an evaluation study with a controlled mixed-methods design"],"prefix":"10.1136","volume":"9","author":[{"given":"Anna","family":"Zinkevich","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah Anna Katharina","family":"Uthoff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens","family":"Boenisch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefanie Kal\u00e9n","family":"Sachse","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tobias","family":"Bernasconi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lena","family":"Ansmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,8,28]]},"reference":[{"key":"2024052013372401000_9.8.e029469.1","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1111\/j.1471-3802.2010.01184.x","article-title":"Implementing AAC with children with profound and multiple learning disabilities: a study in rationale underpinning intervention","volume":"11","author":"Harding","year":"2011","journal-title":"J Res Spec Educ Needs"},{"key":"2024052013372401000_9.8.e029469.2","unstructured":"Beukelman DR , Paul H . 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