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BackgroundSpecialised palliative care trials often fail to address intervention effects on caregiver anxiety and depression, particularly in bereavement. We evaluate effects of specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression in a randomised controlled trial (RCT).MethodsPatients with incurable cancer and limited antineoplastic treatment options and their caregivers, recruited from a university hospital oncology department, were randomised (1:1) to care as usual or accelerated transition from oncological treatment to home-based specialised palliative care. We assessed caregivers’ symptoms of anxiety and depression with the Symptom Checklist-92 up to six months after randomisation and 19 months into bereavement, and estimated intervention effects in mixed effects models.ResultsThe ‘Domus’ trial enrolled 258 caregivers. The intervention significantly attenuated increases in caregivers’ symptoms of anxiety overall (estimated difference, −0.12; 95% confidence interval, −0.22 to −0.01, p = 0.0266), and symptoms of depression at eight weeks (−0.17; −0.33 to −0.02; p = 0.0314), six months (−0.27; −0.49 to −0.05; p = 0.0165), and in bereavement at two weeks (−0.28; −0.52 to −0.03; p = 0.0295) and two months (−0.24; −0.48 to −0.01; p = 0.0448).ConclusionsThis first RCT evaluating specialised palliative care with dyadic psychological support significantly attenuated caregiver anxiety and depression before and during bereavement. (Clinicaltrials.gov: NCT01885637)

The Family Connects (FC) program, a community-wide nurse home visiting program for newborns, has been shown to provide benefits for children and families through the first 2 years of life. Potential longer-term outcomes for child well-being remain unknown. To determine the effect of randomization to FC on child maltreatment investigations and emergency medical care through 5 years of age. In this randomized clinical trial, families of all 4777 resident births in Durham County, North Carolina, from July 1, 2009, to December 31, 2010, were randomly assigned to receive the FC program or treatment as usual. Impact evaluation was on an intent-to-treat basis and focused on a subsample of 549 families randomly selected from the full population and included review of hospital and Child Protective Services (CPS) administrative records. Statistical analysis was conducted from November 6, 2020, to April 25, 2021. The FC programs includes 1 to 3 nurse home visits beginning at the infant age of 3 weeks designed to identify family-specific needs, deliver education and intervention, and connect families with community resources matched to their needs. Ongoing program engagement with service professionals and an electronic resource directory facilitate effective family connections to the community. Two primary trial outcomes were CPS-recorded child maltreatment investigations and emergency medical care use based on hospital records. Of the 4777 randomized families, 2327 were allocated to the intervention, and 2440 were allocated to services as usual. Among the children in the full study population, 2380 (49.8%) were female, 2397 (50.2%) were male, and 3359 (70.3%) were from racial/ethnic minority groups; of the 531 children included in the impact evaluation follow-up, 284 (53.5%) were female, 247 (46.5%) were male, and 390 (73.4%) were from racial/ethnic minority groups. Negative binomial models indicated that families assigned to FC had 39% fewer CPS investigations for suspected child maltreatment through 5 years of age (95% CI, -0.80 to 0.06; 90% CI, -0.73 to -0.01; control = 44 total investigations per 100 children and intervention = 27 total investigations per 100 children); intervention effects did not differ across subgroups. Families assigned to FC also had 33% less total child emergency medical care use (95% CI, -0.59 to -0.14; 90% CI, -0.55 to -0.18; control = 338 visits and overnight hospital stays per 100 children and intervention = 227 visits and overnight hospital stays per 100 children). Positive effects held across birth risk, child health insurance, child sex, single-parent status, and racial/ethnic groups. Effects were larger for nonminority families compared with minority families. The findings of this randomized clinical trial suggest that, when implemented with high quality and broad reach, a brief postpartum nurse home visiting program can reduce population rates of child maltreatment and emergency medical care use in early childhood. ClinicalTrials.gov Identifier: NCT01406184.

Background Heart failure (HF) is the leading cause of mortality, morbidity, and rehospitalization in Appalachia. Rural areas have the highest HF mortality rates. Rural Appalachians lack access to health services and end-of-life palliative care (EOLPC) and have extreme inequities in health. Methods The aim of this mixed methods randomized controlled trial (RCT) is to test the integrated nurse-led intervention bundle of the HF home EOLPC ( HF -FamPAL home CARE) and to assess its ability to maintain sustainability with rural stakeholders, visiting volunteers, and the WV Faith Community Nurse Network. The participants are adult patients (50 to 80 years) with HF (NYHA III and IV and Stages C and D) and their caregivers (≥ 45 to 80 years). The primary aim is to test the outcomes of patients with HF and family caregivers (104 dyads) managing home supportive EOLPC in rural WV. The secondary aim is to assess the bundled intervention for helpfulness, cost and sustainability. All participants received standard care from their regular providers. The intervention group received 2 home visits, 3 biweekly telephone calls and telephone reinforcement across 12 months. Data collection for both groups was conducted at baseline and at 3, 6, 9, and 12 months. Discussion This RCT supports research to improve health equity by improving access to health services and addressing social determinants of health in underrepresented rural Appalachia. It is designed to test practical, sustainable approaches using available local resources to address HF symptom management, support EOLPC preferences, support older adults’ functional health and HF home caregiving skills, and provide social support. Trial Registration ClinicalTrials.gov NCT06791850 Registered on date 19 January 2025.

BackgroundEffective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST.ObjectiveTo perform a cost–utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency.Patients/InterventionsIn this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up.ResultsPST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, −$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions.ConclusionWeekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

Background Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment. Method A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients’ symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants’ health-related quality of life, their satisfaction with the intervention, and an economic valuation. Discussion This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system. Trial registration The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074 . Registered 9 August, 2019.

In home-based care for severely ill patients, family caregivers' contributions are crucial. This study aimed to explore how a web-based psychoeducational intervention influences family caregivers' experiences in addressing challenges while caring for a patient with life-threatening illnesses during specialized home care. This qualitative study undertook semi-structured interviews with family caregivers of patients with life-threatening illness receiving specialized home care. Family caregivers participated in a randomized controlled trial evaluating a psychoeducational intervention delivered through a website. Interviews were performed with 17 family caregivers; 13 spouses, 2 adult children, 1 parent, and 1 sibling, and analyzed using qualitative content analysis. The results indicate that the intervention resonated with the family caregivers' situation which gave them comfort and awareness. It inspired self-reflection on the caregiver role that provided new insights and encouraged communication with the patient. The intervention prepared family caregivers for the patient's progressing illness and death. While preparing was a help for some, others did not feel ready to face this, which led them to avoid parts of the website. This psychoeducational web-based intervention guided family caregivers as they addressed challenges in caregiving and prepared for the future, and they valued having access to such an intervention. In a time of decreasing healthcare resources, web-based support may be a useful alternative to in-person interventions. It is important to continue developing, evaluating, and implementing web-based interventions to meet the needs of family caregivers.

Background Obstructive sleep apnea syndrome (OSAS) is a common disorder with significant morbidity and mortality. We aimed to evaluate the predictive accuracy of the Berlin questionnaire in patients with suspected OSAS undergoing PSG in the sleep laboratory setting against those going through the Embletta™ portable diagnostic system (Embletta PDS) at home. Methods Patients with suspected OSAS were recruited from respiratory clinics to complete Berlin questionnaire and Epworth Sleepiness Score (ESS). Patients were randomized to undergo either home-based sleep test (group A) or hospital-based polysomnography (PSG) (group B). Results Three hundreds and sixteen subjects with newly referred suspected OSAS were recruited and randomized into group A ( n  = 157) and group B ( n  = 159). The prevalence of moderate to severe OSAS defined as apnea-hypopnea index (AHI) ≥ 15/h was 54%. The Berlin questionnaire identified 69.7% ( n  = 99) of subjects as high risk in group A and 77.5% ( n  = 100) in group B. The sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of the questionnaire to predict an AHI ≥ 15/h as diagnosed by PSG was 78, 23, 67 and 35%. When compared with Embletta PDS, the specificity and NPV increased to 48 and 63%. The area under the Receiver Operator Curve (ROC) based on PSG (AUC = 0.539, 95%CI 0.417, 0.661) and based on home Embletta (AUC = 0.712, 95%CI 0.617, 0.907). Conclusions The questionnaire was not reliable in predicting OSAS through PSG AHI whereas there was some predictive ability in discriminating patients with OSAS from normal subjects based on home Embletta sleep test. Trial registration The study was registered at ClinicalTrials.gov (Identifier: NCT01828216) on 10 April 2013.

ObjectivesToddlers are vulnerable to unintentional injuries. A safety intervention targeting low-income families of toddlers, was effective at improving home safety. The current study examined whether the effect varies by initial home safety problems.Methods277 mother-toddler dyads recruited in the Mid-Atlantic region of the United States during 2007–2010 were randomized into safety promotion (n = 91) or attention-control groups (n = 186). Observers rated participants’ homes with a 9-item safety problem checklist at baseline, and at 6- and 12-months follow-up. Initial home safety problems were categorized as multiple (≥ 4 problems) and none/few (< 4). Linear mixed models assessed the moderating effect with a three-way interaction (time, intervention, and initial safety problems).ResultsAt 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = − 1.55, SE = 0.62, p = 0.013).ConclusionsInterventions targeting families with multiple safety problems may be more effective than universal programming.

The growing complexity of hospital-at-home care highlights the pressing need for continuous professional development to enhance specialized skills. This study aimed to describe the future training and competency needs in hospital-at-home care from the perspective of healthcare administrators and managers. A mixed-method convergent design was used to integrate quantitative and qualitative data on similar topics simultaneously, providing a more comprehensive understanding of system-level competency requirements than either method alone. The data were collected through a nationwide survey (n = 25) and interviews (n = 46), covering all wellbeing services counties in Finland in 2023. Descriptive statistics were used for quantitative data and inductive content analysis for qualitative data. Quantitative results indicate needs for additional training in RAI assessment (68%), mental health care (60%), substance abuse expertise (48%), and managing disruptive behaviors (44%). Qualitative findings highlight broader future competence needs, including digital health; cultural and linguistic competence; interprofessional collaboration; managerial competence; home-environment quality and safety; clinical competence; and autonomy in evidence-based practice. Overall, the mixed-method findings differ yet complement one another: quantitative data identify concrete skill gaps, while qualitative insights emphasize wider, system-level competencies to meet the evolving demands of home-based care. Taken together, these complementary findings indicate that advancing the workforce will require a dual approach: addressing concrete skill deficits while simultaneously developing the broader competencies needed to meet the evolving demands of home-based care. This study informs the creation of structured competency frameworks, enabling nursing leaders to meet the evolving demands of home-based care.

Introduction Implementation fidelity is a challenge for the adoption of evidence-based programs within social service broadly and child welfare specifically. However, implementation fidelity is critical for maintaining the integrity of clinical trials and for ensuring successful delivery of services in public health settings. Methods Promoting First Relationships® (PFR), a 10-week home visiting parenting intervention, was evaluated in two randomized clinical trials with populations of families in child welfare. Seven providers from community agencies participated in the trials and administered PFR. Fidelity data collected included observational measures of provider behavior, provider records, and input from clients to assess training uptake, adherence to content, quality of delivery, program dosage, and participant satisfaction. Results In mock cases to assess training uptake, providers demonstrated an increase in PFR verbalization strategies and a decrease non-PFR verbalizations from pre to post PFR training, and overall this was maintained a year later (Mann–Whitney U’s = 0, p’s < .01). Adherence to content in actual cases was high, with M = 97% of the program elements completed. Quality of delivery varied across providers, indicated by PFR consultation strategies (Wilks’ Lambda F = 18.24, df = 15, p < .001) and global ratings (F = 13.35, df = 5, p < .001). Program dosage was high in both trials (71 and 86% receiving 10 sessions), and participant satisfaction was high (M = 3.9, SD = 0.2; 4 = greater satisfaction). Discussion This system of training and monitoring provides an example of procedures that can be used effectively to achieve implementation fidelity with evidence-based programs in social service practice.