Generalizability and reach of a randomized controlled trial to improve oral health among home care recipients: comparing participants and nonparticipants at baseline and during follow-up.

BACKGROUND: The generalizability of randomized controlled trials (RCTs) with a low response can be limited by systematic differences between participants and nonparticipants. This participation bias, however, is rarely investigated because data on nonparticipants is usually not available. The purpose of this article is to compare all participants and nonparticipants of a RCT to improve oral health among home care recipients at baseline and during follow-up using claims data. METHODS: Seven German statutory health and long-term care insurance funds invited 9656 home care recipients to participate in the RCT MundPflege. Claims data for all participants (n = 527, 5.5% response) and nonparticipants (n = 9129) were analyzed. Associations between trial participation and sex, age, care dependency, number of Elixhauser diseases, and dementia, as well as nursing, medical, and dental care utilization at baseline, were investigated using multivariable logistic regression. Associations between trial participation and the probability of (a) moving into a nursing home, (b) being hospitalized, and (c) death during 1 year of follow-up were examined via Cox proportional hazards regressions, controlling for baseline variables. RESULTS: At baseline, trial participation was positively associated with male sex (odds ratio 1.29 [95% confidence interval 1.08-1.54]), high (vs. low 1.46 [1.15-1.86]) care dependency, receiving occasional in-kind benefits to relieve caring relatives (1.45 [1.15-1.84]), having a referral by a general practitioner to a medical specialist (1.62 [1.21-2.18]), and dental care utilization (2.02 [1.67-2.45]). It was negatively associated with being 75-84 (vs. < 60 0.67 [0.50-0.90]) and 85 + (0.50 [0.37-0.69]) years old. For morbidity, hospitalizations, and formal, respite, short-term, and day or night care, no associations were found. During follow-up, participants were less likely to move into a nursing home than nonparticipants (hazard ratio 0.50 [0.32-0.79]). For hospitalizations and mortality, no associations were found. CONCLUSIONS: For half of the comparisons, differences between participants and nonparticipants were observed. The RCT's generalizability is limited, but to a smaller extent than one would expect because of the low response. Routine data provide a valuable source for investigating potential differences between trial participants and nonparticipants, which might be used by future RCTs to evaluate the generalizability of their findings. TRIAL REGISTRATION: German Clinical Trials Register DRKS00013517 . Retrospectively registered on June 11, 2018.

Effectiveness of a Dental Intervention to Improve Oral Health among Home Care Recipients: A Randomized Controlled Trial.

We quantified the effectiveness of an oral health intervention among home care recipients. Seven German insurance funds invited home care recipients to participate in a two-arm randomized controlled trial. At t0, the treatment group (TG) received an intervention comprising an oral health assessment, dental treatment recommendations and oral health education. The control group (CG) received usual care. At t1, blinded observers assessed objective (Oral Health Assessment Tool (OHAT)) and subjective (Oral Health Impact Profile (OHIP)) oral health and the objective periodontal situation (Periodontal Screening Index (PSI)). Of 9656 invited individuals, 527 (5.5%) participated. In the TG, 164 of 259 (63.3%) participants received the intervention and 112 (43.2%) received an outcome assessment. In the CG, 137 of 268 (51.1%) participants received an outcome assessment. The OHAT mean score (2.83 vs. 3.31, p = 0.0665) and the OHIP mean score (8.92 vs. 7.99, p = 0.1884) did not differ significantly. The prevalence of any periodontal problems (77.1% vs. 92.0%, p = 0.0027) was significantly lower in the TG than in the CG, but the prevalence of periodontitis was not (35.4% vs. 44.6%, p = 0.1764). Future studies should investigate whether other recruitment strategies and a more comprehensive intervention might be more successful in improving oral health among home care recipients.

Home care recipients have poorer oral health than nursing home residents: Results from two German studies.

OBJECTIVES: To describe and compare the objective and subjective oral health of older nursing home residents and home care recipients, and to investigate whether oral health is associated with sociodemographic characteristics and the long-term care (LTC) setting. METHODS: In two German studies, the oral health of 246 nursing home residents and 90 home care recipients aged ≥60 years was assessed objectively using the Oral Health Assessment Tool (OHAT) and subjectively using the Oral Health Impact Profile (OHIP). OHAT and OHIP scores were compared between both settings. Multivariable logistic regressions were applied to investigate whether oral health is associated with sex, age group, LTC grade, and LTC setting. RESULTS: OHAT and OHIP mean scores in the home care setting were higher compared to the nursing home setting (OHAT: 3.13 vs. 1.28, p < .0001; OHIP: 7.81 vs. 2.15, p < .0001). The adjusted odds ratios for poor objective and subjective oral health for home care recipients vs. nursing home residents were 6.71 (95 % confidence interval 3.29-13.69) and 4.92 (2.77-8.76). No significant associations with sociodemographic characteristics were found. CONCLUSIONS: Oral health was poor in both settings, but home care recipients were more likely to have poor oral health than nursing home residents. Interventions to improve oral health are needed in the nursing home setting and, even more importantly, in the home care setting. CLINICAL SIGNIFICANCE: Oral health among older people in need of LTC is poor and should be improved. From a health policy perspective, home care recipients may need more attention.