Project description:IntroductionIn patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome, and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness are lacking.AimTo determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness.DesignA feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up).InterventionPatients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the 6 months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline and 1, 3, and 6 months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consultations will be based on middle-range theory of self-care.OutcomeFeasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors, and health outcomes will be evaluated in the intervention and the control group at baseline and 1, 3, 6, and 12 months.DiscussionThe present study will contribute with knowledge on how to implement a feasible social support intervention targeting patients treated for cardiac disease who experience loneliness and, furthermore, investigate the preliminary effect on health behavior and health outcome in the early rehabilitation period.Trial registrationThe trial is registered on clinicaltrials.gov (NCT05503810) 18.08.2022.
Project description:BackgroundEffective methods of secondary prevention after stroke or TIA are available but adherence to recommended evidence-based treatments is often poor. The study aimed to determine the quality of secondary prevention in usual care and to develop a stepwise modeled support program.MethodsTwo consecutive cohorts of patients with acute minor stroke or TIA undergoing usual outpatient care versus a secondary prevention program were compared. Risk factor control and medication adherence were assessed in 6-month follow-ups (6M-FU). Usual care consisted of detailed information concerning vascular risk factor targets given at discharge and regular outpatient care by primary care physicians. The stepwise modeled support program additionally employed up to four outpatient appointments. A combination of educational and behavioral strategies was employed.Results168 patients in the observational cohort who stated their openness to participate in a prevention program (mean age 64.7 y, admission blood pressure (BP): 155/84 mmHg) and 173 patients participating in the support program (mean age 67.6 y, BP: 161/84 mmHg) were assessed at 6 months. Proportions of patients with BP according to guidelines were 50% in usual-care and 77% in the support program (p<0.01). LDL<100 mg/dl was measured in 62 versus 71% (p = 0.12). Proportions of patients who stopped smoking were 50 versus 79% (p<0.01). 72 versus 89% of patients with atrial fibrillation were on oral anticoagulation (p = 0.09).ConclusionsRisk factor control remains unsatisfactory in usual care. Targets of secondary prevention were met more often within the supported cohort. Effects on (cerebro-)vascular recurrence rates are going to be assessed in a multicenter randomized trial.
Project description:IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West - Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.
Project description:OBJECTIVES:Although pediatric intensivists philosophically embrace lung protective ventilation for acute lung injury and acute respiratory distress syndrome, we hypothesized that ventilator management varies. We assessed ventilator management by evaluating changes to ventilator settings in response to blood gases, pulse oximetry, or end-tidal CO2. We also assessed the potential impact that a pediatric mechanical ventilation protocol adapted from National Heart Lung and Blood Institute acute respiratory distress syndrome network protocols could have on reducing variability by comparing actual changes in ventilator settings to those recommended by the protocol. DESIGN:Prospective observational study. SETTING:Eight tertiary care U.S. PICUs, October 2011 to April 2012. PATIENTS:One hundred twenty patients (age range 17 d to 18 yr) with acute lung injury/acute respiratory distress syndrome. MEASUREMENTS AND MAIN RESULTS:Two thousand hundred arterial and capillary blood gases, 3,964 oxygen saturation by pulse oximetry, and 2,757 end-tidal CO2 values were associated with 3,983 ventilator settings. Ventilation mode at study onset was pressure control 60%, volume control 19%, pressure-regulated volume control 18%, and high-frequency oscillatory ventilation 3%. Clinicians changed FIO2 by ±5 or ±10% increments every 8 hours. Positive end-expiratory pressure was limited at ~10?cm H2O as oxygenation worsened, lower than would have been recommended by the protocol. In the first 72 hours of mechanical ventilation, maximum tidal volume/kg using predicted versus actual body weight was 10.3 (8.5-12.9) (median [interquartile range]) versus 9.2?mL/kg (7.6-12.0) (p < 0.001). Intensivists made changes similar to protocol recommendations 29% of the time, opposite to the protocol's recommendation 12% of the time and no changes 56% of the time. CONCLUSIONS:Ventilator management varies substantially in children with acute respiratory distress syndrome. Opportunities exist to minimize variability and potentially injurious ventilator settings by using a pediatric mechanical ventilation protocol offering adequately explicit instructions for given clinical situations. An accepted protocol could also reduce confounding by mechanical ventilation management in a clinical trial.
Project description:PurposeOsteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown.MethodsPatient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.ResultsWe enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01), improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively), had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001). Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer). There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07); medication adherence at 6 months was no different across arms.ConclusionSupporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.Trial registrationclinical trials.gov NCT00949611.
Project description:To examine whether the usual source of preventive care, (having a usual place for care only or the combination of a usual place and provider compared with no usual source of preventive care) is associated with adults receiving recommended screening and prevention services.Using cross-sectional survey data for 24,138 adults (ages 18-64) from the 1999 National Health Interview Survey (NHIS), we estimated adjusted odds ratios using separate logistic regression models for receipt of five preventive services: influenza vaccine, Pap smear, mammogram, clinical breast exam, and prostate specific antigen.Having both a usual place and a usual provider was consistently associated with increased odds for receiving preventive care/screening services compared to having a place only or neither. Adults ages 50-64 with a usual place/provider had 2.8 times greater odds of receiving a past year flu shot compared with those who had neither. Men ages 50-64 with a usual place/provider had nearly 10 times higher odds of receiving a PSA test compared with men who had neither. Having a usual place/provider compared with having neither was associated with 3.9 times higher odds of clinical breast exam among women ages 20-64, 4.1 times higher odds of Pap testing among women ages 21-64, and 4.8 times higher odds of mammogram among women ages 40-64.Having both a usual place and usual provider is a key variable in determining whether adults receive recommended screening and prevention services and should be considered a fundamental component of any medical home model for adults.
Project description:BackgroundAlthough clinical decision support systems (CDSS) have been developed to enhance the quality and efficiency of surgeries, little is known regarding the practical effects in real-world perioperative care.ObjectiveTo systematically review and meta-analyze the current impact of CDSS on various aspects of perioperative care, providing evidence support for future research on CDSS development and clinical implementation.MethodsThis systematic review and meta-analysis followed the Cochrane Handbook and PRISMA statement guidelines, searching databases up to February 2, 2024, including MEDLINE, PubMed, Embase, Cochrane, and Web of Science. It included studies on the effectiveness of CDSS in assisting perioperative decision-making, involving anaesthesiologists, doctors, or surgical patients, and reporting at least one outcome such as complications, mortality, length of stay, compliance, or cost.ResultsForty studies met inclusion criteria, analyzing outcomes from 408,357 participants, predominantly in developed countries. Most perioperative CDSS use was associated with improved guideline adherence, decreased medication errors, and some improvements in patient safety measures such as reduced postoperative nausea and vomiting and myocardial injury. However, reported results varied widely, and no significant improvement in postoperative mortality was observed.ConclusionThe preliminary findings of this review offer an overview of the potential use of CDSS in real-world perioperative situations to enhance patient and anaesthesiologist outcomes, but further researches with broader outcome dimensions, involving more stakeholders, and with longer follow-up periods are warranted for the critical evaluation of CDSS and then in better facilitate clinical adoption.
Project description:BackgroundPlantar fasciitis (PF) results in pain-related disability and excessive healthcare costs. Photobiomodulation therapy (PBMT) has shown promise for decreasing both pain and disability related to PF.PurposeThe purpose was to assess the clinical impact of PBMT on pain and function in people with PF.Study designProspective, randomized controlled clinical trial.MethodsA convenience sample of adults with PF were randomly assigned to one of three groups: (1) usual care, (2) usual care plus nine doses of PBMT with 25W output power over three weeks, or (3) usual care plus nine doses of PBMT with 10W output power over three weeks. Both 10W and 25W PBMT participants received the same total dose (10J/cm2) by utilizing a simple area equation. Pain (with Defense and Veterans Pain Rating Scale) and function (by Foot and Ankle Ability Measure) were measured at baseline, weeks 3, and 6 for all groups, and at 13 and 26 weeks for PBMT groups.ResultsPBMT groups experienced a reduction in pain over the first three weeks (from an average of 4.5 to 2.8) after which their pain levels remained mostly constant, while the UC group experienced a smaller reduction in pain (from an average of 4 to 3.8). The effects on pain were not different between PBMT groups. PBMT in both treatment groups also improved function more than the UC group, again with the improvement occurring within the first three weeks.ConclusionsPain and function improved during the three weeks of PBMT plus UC and remained stable over the following three weeks. Improvements sustained through six months in the PBMT plus UC groups.Level of evidenceLevel II- RCT or Prospective Comparative Study.