Effectiveness of a Dental Intervention to Improve Oral Health among Home Care Recipients: A Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Czwikla J
PROVIDER: S-EPMC8430536 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe 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.MethodsSeven 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.ResultsAt 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.ConclusionsFor 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 registrationGerman Clinical Trials Register DRKS00013517 . Retrospectively registered on June 11, 2018.
| S-EPMC9264743 | biostudies-literature
Project description:BACKGROUND:Fostering a culture of safety is an essential step in ensuring patient safety and quality in primary care. We aimed to evaluate the effectiveness of an educational intervention to improve the safety culture in the family and community medicine teaching units in an Atlantic European Region. METHODS:Randomized study conducted in family and community medicine teaching units in Galicia (Spain). Participants were all fourth-year residents and their tutors (N?=?138). Those who agreed to participate were randomized into one of two groups (27 tutors/26 residents in the intervention group, 23 tutors/ 23 residents in the control one).All were sent the Survey on Patient Safety Culture. After that, the intervention group received specific training in safety; they also recorded incidents over 15?days, documented them following a structured approach, and had feedback on their performance. The control group did not receive any action. All participants completed the same survey four months later. Outcome measures were the changes in safety culture as quantified by the results variables of the Survey: Patient Safety Grade and Number of events reported. We conducted bivariate and adjusted analyses for the outcome measures. To explore the influence of participants' demographic characteristics and their evaluation of the 12 dimensions of the safety culture, we fitted a multivariate model for each outcome. RESULTS:Trial followed published protocol. There were 19 drop outs. The groups were comparable in outcome and independent variables at start. The experiment did not have any effect on Patient safety grade (-?0.040) in bivariate analysis. The odds of reporting one to two events increased by 1.14 (0.39-3.35), and by 13.75 (2.41-354.37) the odds of reporting 3 or more events. Different dimensions had significant independent effects on each outcome variable. CONCLUSION:A educational intervention in family and community medicine teaching units may improve the incidents reported. The associations observed among organizational dimensions and outcomes evidence the complexity of patient safety culture measurement and, also, show the paths for improvement. In the future, it would be worthwhile to replicate this study in teaching units from different settings and with different health professionals engaged. TRIAL REGISTRATION:It was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).
| S-EPMC6337818 | biostudies-other
Project description:Background:Research shows that immigrants have higher rates of oral diseases, poorer access to dental care services, and lower levels of health literacy than their Canadian-born peers. Oral health literacy has emerged as a potential pathway to reduce oral health disparities. The scarcity of studies on oral health literacy interventions, particularly among immigrants, lent urgency to this study, the purpose of which was to evaluate the effectiveness of an oral health literacy intervention promoting oral hygiene self-care behaviour among Punjabi immigrants. Methods:The study used a parallel group, non-blinded, randomized controlled trial design. One hundred and forty (140) Punjabi immigrants between 18 and 60 years of age were enrolled. Participants were randomly allocated to receive either the Safeguard Your Smile (SYS) intervention or a conventional pamphlet. The following outcome measures were assessed at baseline and 3 months post-intervention: self-reported oral hygiene self-care behaviour and knowledge, plaque and gingival indices, and oral health literacy. A linear mixed model for repeated measures was used to compare the intervention and control groups (between) at pre- and post-intervention (within). Results:Participants who received the SYS intervention showed improvements ( p <0.0001) for the following dependent variables: oral hygiene self-care knowledge and behaviour, oral health literacy, and plaque and gingival indices. Conclusions:SYS intervention enhanced positive oral hygiene self-care behaviour among Punjabi immigrants with low oral health literacy. SYS intervention can be employed among other vulnerable groups with low levels of oral health literacy to improve oral hygiene self-care behaviour.
| S-EPMC7533823 | biostudies-literature
Project description:Patients with depression and poorly controlled diabetes mellitus, coronary heart disease (CHD), or both have higher medical complication rates and higher health care costs, suggesting that more effective care management of psychiatric and medical disease control might also reduce medical service use and enhance quality of life.To evaluate the cost-effectiveness of a multicondition collaborative treatment program (TEAMcare) compared with usual primary care (UC) in outpatients with depression and poorly controlled diabetes or CHD.Randomized controlled trial of a systematic care management program aimed at improving depression scores and hemoglobin A(1c) (HbA(1c)), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) levels.Fourteen primary care clinics of an integrated health care system.Population-based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD.Physician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors.Blinded assessments evaluated depressive symptoms, SBP, and HbA(1c) at baseline and at 6, 12, 18, and 24 months. Fasting LDL-C concentration was assessed at baseline and at 12 and 24 months. Health plan accounting records were used to assess medical service costs. Quality-adjusted life-years (QALYs) were assessed using a previously developed regression model based on intervention vs UC differences in HbA(1c), LDL-C, and SBP levels over 24 months.Over 24 months, compared with UC controls, intervention patients had a mean of 114 (95% CI, 79 to 149) additional depression-free days and an estimated 0.335 (95% CI, -0.18 to 0.85) additional QALYs. Intervention patients also had lower mean outpatient health costs of $594 per patient (95% CI, -$3241 to $2053) relative to UC patients.For adults with depression and poorly controlled diabetes, CHD, or both, a systematic intervention program aimed at improving depression scores and HbA(1c), SBP, and LDL-C levels seemed to be a high-value program that for no or modest additional cost markedly improved QALYs.clinicaltrials.gov Identifier: NCT00468676
| S-EPMC3840955 | biostudies-literature
Project description:We conducted a cluster randomized trial testing the effectiveness of an intervention to increase the use of osteoporosis medications in high-risk patients receiving home health care. The trial did not find a significant difference in medication use in the intervention arm.This study aims to test an evidence implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures.We conducted a cluster randomized trial of a multimodal intervention targeted at home care for high-risk patients (prior fracture or physician-diagnosed osteoporosis) receiving care in a statewide home health agency in Alabama. Offices throughout the state were randomized to receive the intervention or to usual care. The primary outcome was the proportion of high-risk home health patients treated with osteoporosis medications. A t test of difference in proportions was conducted between intervention and control arms and constituted the primary analysis. Secondary analyses included logistic regression estimating the effect of individual patients being treated in an intervention arm office on the likelihood of a patient receiving osteoporosis medications. A follow-on analysis examined the effect of an automated alert built into the electronic medical record that prompted the home health care nurses to deploy the intervention for high-risk patients using a pre-post design.There were 11 offices randomized to each of the treatment and control arms; these offices treated 337 and 330 eligible patients, respectively. Among the offices in the intervention arm, the average proportion of eligible patients receiving osteoporosis medications post-intervention was 19.1 %, compared with 15.7 % in the usual care arm (difference in proportions 3.4 %, 95 % CI, -2.6 to 9.5 %). The overall rates of osteoporosis medication use increased from 14.8 % prior to activation of the automated alert to 17.6 % afterward, a nonsignificant difference.The home health intervention did not result in a significant improvement in use of osteoporosis medications in high-risk patients.
| S-EPMC4089895 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a nurse-led hospital-to-home transitional care intervention versus usual care on mental functioning (primary outcome), physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health service use costs in older adults with multimorbidity (≥ 2 comorbidities) and depressive symptoms.Design and settingPragmatic multi-site randomized controlled trial conducted in three communities in Ontario, Canada. Participants were allocated into two groups of intervention and usual care (control).Participants127 older adults (≥ 65 years) discharged from hospital to the community with multimorbidity and depressive symptoms.InterventionThis evidence-based, patient-centred intervention consisted of individually tailored care delivery by a Registered Nurse comprising in-home visits, telephone follow-up and system navigation support over 6-months.Outcome measuresThe primary outcome was the change in mental functioning, from baseline to 6-months. Secondary outcomes were the change in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health service use cost, from baseline to 6-months. Intention-to-treat analysis was performed using ANCOVA modeling.ResultsOf 127 enrolled participants (63-intervention, 64-control), 85% had six or more chronic conditions. 28 participants were lost to follow-up, leaving 99 (47 -intervention, 52-control) participants for the complete case analysis. No significant group differences were seen for the baseline to six-month change in mental functioning or other secondary outcomes. Older adults in the intervention group reported receiving more information about health and social services (p = 0.03) compared with the usual care group.ConclusionsAlthough no significant group differences were seen for the primary or secondary outcomes, the intervention resulted in improvements in one aspect of patient experience (information about health and social services). The study sample fell below the target sample (enrolled 127, targeted 216), which can account for the non-significant findings. Further research on the impact of the intervention and factors that contribute to the results is recommended.Trial registrationclinicaltrials.gov Identifier: NCT03157999.
| S-EPMC8312945 | biostudies-literature
Project description:Family caregivers (FC) often experience higher distress levels than their relative with cancer. Many cancer centers have implemented distress screening programs, but most of them concentrate their efforts on patients, with little attention to their FC. To fill this gap, a pragmatic intervention has been designed to improve supportive care for FC of patients with lung cancer. This article describes the study protocol of a single-center randomized controlled trial to assess its effectiveness.A total of 120 lung cancer patients and their FC are randomly assigned to the experimental group (exposed to intervention, N?=?60) or to the control group (usual care, N?=?60). The intervention includes: (1) systematic FC distress screening and problem assessment near their relative's cancer diagnosis, and every 2 months, (2) privileged contact with an oncology nurse (ON) away from the patient to address FC problems and (3) liaison by the ON with the family physician of FC reporting high distress (thermometer score ?5/10), or problems relying on FP expertise. In both groups, FC, patient and process-of-care outcomes are measured at baseline and every 3 months, up to 9 months. The primary endpoint is FC distress measured by the Hospital Anxiety and Depression Scale (HADS) and the Psychological Distress Index used in the Quebec Health Survey (PDQHS). Individual interviews with 10 FC and a focus group with the oncology team will be conducted at the study end to further document the effectiveness of the intervention and its impact on quality of life (for FC) and practice organization (for the oncology team).This trial will assess the effectiveness of an innovative intervention based on interprofessional collaboration between primary care and oncology care. It targets a population in great need, yet often neglected, and has the potential to clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.ClinicalTrials.gov, ID: NCT02531464 . Registered on 15 July 2015.
| S-EPMC5496252 | biostudies-literature
Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.
| S-EPMC2219825 | biostudies-other
Project description:BackgroundOral health is considered a prominent factor that contributes to quality of life. Hormonal changes during pregnancy can influence oral health. Message framing can play an important role in oral health. The aim of the present study was to investigate the effect of message framing on oral health and dental plaque among pregnant women.MethodsThe study was conducted in 2017 on 108 pregnant women in Izeh county, Iran. Participants were randomly assigned to gain-framed, loss-framed, and control groups. The research instrument included a two part questionnaire containing demographic information and oral health knowledge, attitude, behavioral intention, self-efficacy, practice, and dental plaque index. Gain-and loss-framed messages were sent to the intervention groups via cell phone texts, but the control group did not receive any messages. Participant dental plaque was clinically assessed. Analysis of covariance with follow-up tests were performed using SPSS version, 23.0 with p-value set at 0.01 for significance.ResultsIntervention groups had better oral health (knowledge, atttitude, intention, efficacy, practices and plaque) scores compared to the control group (p < 0.001), but intervention (gain- vs loss-framed) groups did not differ on outcomes.ConclusionText message intervention improved knowledge, attitude, behavioral intention, self-efficacy, practice, and dental plaque among pregnant women. While differences between control and both intervention groups indicated text messaging had an impact on oral health outcomes, message framing (i.e., gain vs loss) had no discernable impact on oral health outcomes.
| S-EPMC8237427 | biostudies-literature
Project description:BACKGROUND: Feedback is potentially effective in improving the quality of care. However, merely sending reports is no guarantee that performance data are used as input for systematic quality improvement (QI). Therefore, we developed a multifaceted intervention tailored to prospectively analyzed barriers to using indicators: the Information Feedback on Quality Indicators (InFoQI) program. This program aims to promote the use of performance indicator data as input for local systematic QI. We will conduct a study to assess the impact of the InFoQI program on patient outcome and organizational process measures of care, and to gain insight into barriers and success factors that affected the program's impact. The study will be executed in the context of intensive care. This paper presents the study's protocol. METHODS/DESIGN: We will conduct a cluster randomized controlled trial with intensive care units (ICUs) in the Netherlands. We will include ICUs that submit indicator data to the Dutch National Intensive Care Evaluation (NICE) quality registry and that agree to allocate at least one intensivist and one ICU nurse for implementation of the intervention. Eligible ICUs (clusters) will be randomized to receive basic NICE registry feedback (control arm) or to participate in the InFoQI program (intervention arm). The InFoQI program consists of comprehensive feedback, establishing a local, multidisciplinary QI team, and educational outreach visits. The primary outcome measures will be length of ICU stay and the proportion of shifts with a bed occupancy rate above 80%. We will also conduct a process evaluation involving ICUs in the intervention arm to investigate their actual exposure to and experiences with the InFoQI program. DISCUSSION: The results of this study will inform those involved in providing ICU care on the feasibility of a tailored multifaceted performance feedback intervention and its ability to accelerate systematic and local quality improvement. Although our study will be conducted within the domain of intensive care, we believe our conclusions will be generalizable to other settings that have a quality registry including an indicator set available. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50542146.
| S-EPMC3217909 | biostudies-other