Supervised versus non-supervised implementation of an oral health care guideline in (residential) care homes: a cluster randomized controlled clinical trial

BACKGROUND: The increase of the proportion of elderly people has implications for health care services. Advances in oral health care and treatment have resulted in a reduced number of edentulous individuals. An increasing number of dentate elderly people have tooth wear, periodontal disease, oral implants, and sophisticated restorations and prostheses. Hence, they are in need of both preventive and curative oral health care continuously. Weakened oral health due to neglect of self care and professional care and due to reduced oral health care utilization is already present when elderly people are still community-dwelling. At the moment of (residential) care home admittance, many elderly people are in need of oral health care urgently. The key factor in realizing and maintaining good oral health is daily oral hygiene care. For proper daily oral hygiene care, many residents are dependent on nurses and nurse aides. In 2007, the Dutch guideline "Oral health care in (residential) care homes for elderly people" was developed. Previous implementation research studies have revealed that implementation of a guideline is very complicated. The overall aim of this study is to compare a supervised versus a non-supervised implementation of the guideline in The Netherlands and Flanders (Belgium). METHODS/DESIGN: The study is a cluster randomized intervention trial with an institution as unit of randomization. A random sample of 12 (residential) care homes accommodating somatic as well as psycho-geriatric residents in The Netherlands as well as in Flanders (Belgium) are randomly allocated to an intervention or control group. Representative samples of 30 residents in each of the 24 (residential) care homes are monitored during a 6-months period. The intervention consists of supervised implementation of the guideline and a daily oral health care protocol. Primary outcome variable is the oral hygiene level of the participating residents. To determine the stimulating or inhibiting factors of the implementation project and the nurses' and nurse aides' compliance and perceived barriers, a process evaluation is carried out. DISCUSSION: The method of cluster randomization may result in a random effect and cluster selection bias, which has to be taken into account when analyzing and interpreting the results. TRIAL REGISTRATION: Current Controlled Trials ISRCTN86156614