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[Effectiveness of short educational intervention in patients with insomnia in primary care].

ABSTRACT: OBJETIVE:To evaluate the effectiveness of providing an educational intervention in primary care (PC) alongside a pharmacological treatment for insomnia. DESIGN:Single blinded non randomised clinical trial. LOCATION:Two urban primary health centers in Gijón (Asturias, Spain). PARTICIPANTS:Patients who consulted for insomnia between July 2012-January 2013 and met the inclusion criteria (n=50) were assigned systematically to the control group (CG) or intervention group (IG). All patients initiated treatment with lorazepam 1mg in the evenings and had four weekly 15 min visits plus a follow-up visit after another month. INTERVENTIONS:The IG received training for control of stimuli, sleep hygiene and respiration and relaxation techniques in the four visits. The CG had only non invasive measures taken. MEASUREMENTS:Considering as cured those who reached a Pittsburgh Sleep Quality Index PSQI <6 or a 50% reduction from baseline level. It was also analyzed the change in the PSQI from baseline to final visit and to follow-up visit, and voluntary interruption of lorazepam. Analysis by Bayesian inference. RESULTS:Twelve out of recoveries after intervention against one out of 24 among control group. Mean change in PSQI to final visit and follow-up visit was: -4.7 (95%CrI:-5.9 to -3.5) and -6,3 (95%ICred: -7.5 to -5.1) in IG; -1.8 (95%ICred: -3 to -0.5) and -1.7 (95%ICred: -2.9 to -0.4) in CG. Interruption of lorazepan: in 4 controls (16,7%) and 9 (34,6%) in IG. Twenty nine patients in GI and 17 in GC completed the trial. Per protocol analysis showed similar results. CONCLUSIONS:The educational intervention in PC improves sleep quality and reduces the need of treatment with benzodiacepines.

SUBMITTER: Gancedo-Garcia A

PROVIDER: S-EPMC6983818 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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[Effectiveness of short educational intervention in patients with insomnia in primary care].

Gancedo-García Ana A Gutiérrez-Antezana Angélica Faviola AF González-García Pablo P Salinas-Herrero Sally S Prieto-Merino David D Suárez-Gil Patricio P

Atencion primaria 20140628 10

<h4>Objetive</h4>To evaluate the effectiveness of providing an educational intervention in primary care (PC) alongside a pharmacological treatment for insomnia.<h4>Design</h4>Single blinded non randomised clinical trial.<h4>Location</h4>Two urban primary health centers in Gijón (Asturias, Spain).<h4>Participants</h4>Patients who consulted for insomnia between July 2012-January 2013 and met the inclusion criteria (n=50) were assigned systematically to the control group (CG) or intervention group ...[more]

PMID: 24986634

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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).

Project description:BackgroundThe rates of exclusive breastfeeding at 6 months in Spain are far from recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care.MethodMulticentre cluster randomized clinical trial. A total of 434 mother-child dyads who breastfed exclusively in the first 4 weeks of the children's life and agreed to participate were included. The main outcome was exclusive breastfeeding at 6 months. Secondary variables were type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed to intention to treat.ResultsThe percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. PROLACT intervention obtained an RR =2.53 (95% CI: 1.54-4.15) and an NNT = 7 (95%CI: 5-14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR = 3.51 (95%CI: 1.55-7.93); age > 39 years, OR = 2.79 (95%CI: 1.02-7.6); previous breastfeeding experience, OR = 2.61 (95%CI: 1.29-5.29); income between 500 and 833.33 €, OR = 3.52 (95%CI 1.47-8.47).); planning to start work before the infant was 6 months old, OR = 0.35 (0.19-0.63) .ConclusionsThe PROLACT intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months, and can therefore be considered evidence-based practice for implementation in standard practice.Trial registrationThe trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

Project description:BackgroundThe SingHypertension primary care clinic intervention, which consisted of clinician training in hypertension management, subsidized single-pill combination medications, nurse-delivered motivational conversations and telephone follow-ups, improved blood pressure control and cardiovascular disease (CVD) risk scores relative to usual care among patients with uncontrolled hypertension in Singapore. This study quantified the incremental cost-effectiveness, in terms of incremental cost per unit reduction disability-adjusted life years, of SingHypertension relative to usual care for patients with hypertension from the health system perspective.Methods and resultsWe developed a Markov model to simulate CVD events and associated outcomes for a hypothetical cohort of patients over a 10-year period. Costs were measured in US dollars, and effectiveness was measured in disability-adjusted life years averted. We present base-case results and conducted deterministic and probabilistic sensitivity analyses. Based on a willingness-to-pay threshold of US $55 500 per DALY averted, SingHypertension was cost-effective for patients with hypertension (incremental cost-effectiveness ratio: US $24 765 per disability-adjusted life year averted) relative to usual care. This result held even if risk reduction was assumed to decline linearly to 0 over 10 years but not sooner than 7 years. Incremental cost-effectiveness ratios were most sensitive to the magnitude of the reduction in CVD risk; at least a 0.13% to 0.16% point reduction in 10-year CVD risk is required for cost-effectiveness. Probabilistic sensitivity analysis indicates that SingHypertension has a 78% chance of being cost-effective at the willingness-to-pay threshold.ConclusionsSingHypertension represents good value for the money for reducing CVD incidence, morbidity, and mortality and should be considered for wide-scale implementation in Singapore and possibly other countries.Registration informationREGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02972619.

Project description:BackgroundThe World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding. Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions.MethodsThis study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate. The main response variable is mother-infant pairs using exclusive breast-feeding at six months. Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models.DiscussionWe must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period.Trial registrationThe trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013).

Project description:BackgroundPatients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD.MethodsThis trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy.DiscussionThis clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD.Trial registrationNCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).

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[Effectiveness of short educational intervention in patients with insomnia in primary care].

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[Effectiveness of short educational intervention in patients with insomnia in primary care].

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