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:BackgroundImproving care transitions following emergency department (ED) visits may reduce post-ED adverse events among older adults (e.g., ED revisits, decreased function). The Care Transitions Intervention (CTI) improves hospital-to-home transitions; however, its effectiveness at improving post-ED outcomes is unknown. We tested the effectiveness of the CTI with community-dwelling older adult ED patients, hypothesizing that it would reduce revisits and increase performance of self-management behaviors during the 30 days following discharge.MethodsWe conducted a randomized controlled trial among patients age ≥ 60 discharged home from one of three EDs in two states. Intervention participants received a minimally modified CTI, with a home visit 24 to 72 h postdischarge and one to three phone calls over 28 days. We collected demographic, health status, and psychosocial data at the initial ED visit. Medication adherence and knowledge of red flag symptoms were assessed via phone survey. Care use and comorbidities were abstracted from medical records. We performed multivariate regressions for intention-to-treat and per-protocol (PP) analyses.ResultsParticipant characteristics (N = 1,756) were similar across groups: mean age 72.4 ± 8.6 years and 53% female. Of those randomized to the intervention, 84% completed the home visit. Overall, 12.4% of participants returned to the ED within 30 days. The CTI did not significantly affect odds of 30-day ED revisits (adjusted odds ratio [AOR] = 0.97, 95% confidence interval [CI] = 0.72 to 1.30) or medication adherence (AOR = 0.89, 95% CI = 0.60 to 1.32). Participants receiving the CTI (PP) had increased odds of in-person follow-up with outpatient clinicians during the week following discharge (AOR = 1.24, 95% CI = 1.01 to 1.51) and recalling at least one red flag from ED discharge instructions (AOR = 1.34 95% CI = 1.05 to 1.71).ConclusionsThe CTI did not reduce 30-day ED revisits but did significantly increase key care transition behaviors (outpatient follow-up, red flag knowledge). Additional research is needed to explore if patients with different conditions benefit more from the CTI and whether decreasing ED revisits is the most appropriate outcome for all older adults.
| S-EPMC8766871 | biostudies-literature
Project description:BackgroundAccording to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.MethodsThis is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.DiscussionThis study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.Trial registrationClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.
| S-EPMC9465132 | biostudies-literature
Project description:BackgroundA growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use.ObjectiveThis study aims to evaluate the intervention effects, adherence, and acceptance of an unguided app-based intervention for individuals who wish to improve their sleep.MethodsIn a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared with a waitlist condition. Refresh is an 8-week unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary. The primary outcome was sleep quality (insomnia symptoms) as self-assessed by the Regensburg Insomnia Scale (RIS). The secondary outcomes were depression (9-item Patient Health Questionnaire [PHQ-9] score) and perceived insomnia-related impairment.ResultsWe included 371 participants, of which 245 reported poor sleep at baseline. About 1 in 3 participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average 4 out of 8 chapters. Retention rates were 67.4% (n=250) at postassessment and 57.7% (n=214) at the 6-month follow-up. At postintervention, insomnia symptoms in the intervention group had improved more than those in the waitlist group, with a small effect (d=0.26) in the whole sample and a medium effect (d=0.45) in the subgroup with poor sleep. Effects in the intervention group were maintained at follow-up. Perceived insomnia-related impairment also improved from pre- to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good.ConclusionsAn app-based, unguided intervention is a feasible and effective option to scale-up CBT-I-based treatment, but intervention uptake and adherence need to be carefully addressed.Trial registrationISRCTN Registry ISRCTN53553517; https://www.isrctn.com/ISRCTN53553517.
| S-EPMC10131838 | biostudies-literature
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:ContextPatients 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.ObjectiveTo 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.DesignRandomized 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.SettingFourteen primary care clinics of an integrated health care system.PatientsPopulation-based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD.InterventionPhysician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors.Main outcome measuresBlinded 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.ResultsOver 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.ConclusionsFor 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.Trial registrationclinicaltrials.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:BackgroundFostering 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.MethodsRandomized 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.ResultsTrial 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.ConclusionA 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 registrationIt was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).
| S-EPMC6337818 | 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: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