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Dentistry and oral medicine
Protocol
Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial
  1. Katrin Hertrampf1,
  2. Peter Schlattmann2,
  3. Gabriele Meyer3,
  4. Georg Gassmann4,
  5. Jens Abraham3,
  6. Volker Hammen5,
  7. Falk Schwendicke6
  1. 1Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Kiel, Germany
  2. 2Medical Statistics, Computer and DataSciences, Friedrich-Schiller-Universitat Jena, Jena, Germany
  3. 3Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany
  4. 4praxisHochschule pHfG Trägergesellschaft, praxisHochschule University of Applied Sciences, Cologne, Germany
  5. 5praxisHochschule University of Applied Sciences, praxisHochschule University of Applied Sciences, Cologne, Germany
  6. 6Zahnerhaltung, Charite Universitatsmediz in Berlin Campus Benjamin Franklin, Berlin, Germany
  1. Correspondence to Dr Falk Schwendicke; falk.schwendicke{at}charite.de

Abstract

Introduction Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor. We will develop an evidence-based catalogue of interventions (‘Oral Health Toolbox’) and provide care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA). We hypothesise that such intervention will significantly improve OHrQL, daily oral hygiene/care behaviour and is cost-effective.

Methods and analysis A scoping review will be used to identify possible intervention components. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German LRC. The result will be the ‘Oral Health Toolbox’, a two-phased instrument supporting both initial intervention allocation to improve oral health/hygiene and reinstruction/remotivation. A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, we aim at recruiting 618 residents in 18 clusters. In the intervention group, dentists will assign one or more intervention component from the box (phase 1). During follow-up, nursing staff will be reinstructed and remotivated by DA, who use the box to decide how to maintain the intervention (phase 2). In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the General Oral Health Assessment Index. Secondary outcomes include pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For our primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial.

Ethics and dissemination Ethical approval by the University of Kiel was granted (D480/18).

Trial registration number NCT04140929.

  • study protocol
  • health services research
  • nursing homes
  • oral hygiene
  • cluster-randomized clinical trial
  • quality of life
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-035999

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    Footnotes

    • Contributors KH and FS conceived and designed the study, planned data recording and analysis, and wrote the manuscript. PS, GM, GG, JA, and VH planned data recording and analysis, and revised the manuscript. All authors have agreed to the final version of this manuscript and accepted responsibility for it.

    • Funding This study is funded by the Innovationsfond des Gemeinsamen Bundesausschusses (01VSF18021). Open Access publication is supported by the DFG OA Fund of the Charité–Universitätsmedizin Berlin.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.