Dataset Information

Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial.

ABSTRACT: This randomized controlled non-inferiority trial explored the effectiveness of Seeking Safety (SS) delivered by peer providers compared to its delivery by licensed behavioral health clinicians. The study enrolled 291 adults with PTSD and/or substance use disorders. Data were collected at 3 and 6-months post start of treatment. With respect to long-term outcomes, at 6 months PTSD symptoms decreased by 5.1 points [95% CI (-?9.0, -?1.1)] and by 4.9 points [95% CI (-?8.6, -?1.1)] and coping skills increased by 5.5 points [95% CI (0.4, 10.6)] and by 5.6 points [95% CI (0.8, 10.4)], in the peer- and clinician-led groups, respectively. This study demonstrated non-inferiority of peer-delivered SS compared to clinician-delivered SS for reducing PTSD symptoms and similar outcomes for both groups with respect to coping skills. A confirmatory study on the effectiveness of peer-delivered trauma-specific services is warranted, especially given the potential for increasing access to such treatment in underserved rural communities.

SUBMITTER: Crisanti AS

PROVIDER: S-EPMC6744517 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial.

Crisanti Annette S AS Murray-Krezan Cristina C Reno Jessica J Killough Cynthia C

Community mental health journal 20190723 7

This randomized controlled non-inferiority trial explored the effectiveness of Seeking Safety (SS) delivered by peer providers compared to its delivery by licensed behavioral health clinicians. The study enrolled 291 adults with PTSD and/or substance use disorders. Data were collected at 3 and 6-months post start of treatment. With respect to long-term outcomes, at 6 months PTSD symptoms decreased by 5.1 points [95% CI (- 9.0, - 1.1)] and by 4.9 points [95% CI (- 8.6, - 1.1)] and coping skills i ...[more]

PMID: 31338716

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Project description:IntroductionTraining Basic Life Support saves lives. However, current BLS training approaches are time-consuming and costly. Alternative cost-efficient and effective training methods are highly needed. The present study evaluated whether a video-feedback supported peer-guided Basic Life Support training approach achieves similar practical performance as a standard instructor-guided training in laypersons.MethodsIn a randomized controlled non-inferiority trial, 288 first-year medical students were randomized to two study arms with different Basic Life Support training methods: 1) Standard Instructor Feedback (SIF) or 2) a Peer Video Feedback (PVF). Outcome parameters were objective data for Basic Life Support performance (compression depth and rate) from a resuscitation manikin with recording software as well as overall Basic Life Support performance and subjective confidence. Non-inferiority margins (Δ) for these outcome parameters and sample size calculation were based on previous studies with Standard Instructor Feedback. Two-sided 95% confidence intervals were employed to determine significance of non-inferiority.ResultsResults confirmed non-inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth (proportion difference PVF-SIF = 2.9%; 95% CI: -8.2% to 14.1%; Δ = -19%), overall Basic Life Support performance (proportion difference PVF-SIF = 6.7%; 95% CI: 0.0% to 14.3%; Δ = -27%) and subjective confidence for CPR performance (proportion difference PVF-SIF = -0.01; 95% CI: -0.18-0.17; Δ = -0.5) and emergency situations (proportion difference PVF-SIF = -0.02; 95% CI: -0.21-0.18; Δ = -0.5). Results for compression rate were inconclusive.DiscussionPeer Video Feedback achieves comparable results as standard instructor-based training methods. It is an easy-to-apply and cost-efficient alternative to standard Basic Life Support training methods. To improve performance with respect to compression rate, additional implementation of a metronome is recommended.

Project description:ObjectiveTrauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based therapist-led treatment for children after trauma. Parents often experience barriers to treatment engagement, including cost. Stepped care TF-CBT (SC-TF-CBT) was developed as an alternative delivery system. Step One is a parent-led therapist-assisted treatment. Step Two provides therapist-led TF-CBT for children who did not benefit from Step One and require more intensive treatment. This study compared SC-TF-CBT to standard TF-CBT in a community-based non-inferiority trial.MethodA total of 183 children (aged 4-12 years) experiencing posttraumatic stress symptoms (PTSS) and their caregivers were randomly assigned to SC-TF-CBT or standard TF-CBT within 6 community clinics. Assessments occurred at baseline, mid- and posttreatment, and 6 and 12 months. Primary outcomes included PTSS and impairment. Secondary outcomes included severity, diagnostic status, remission, and response. Treatment cost, acceptability, and satisfaction were measured. Difference and non-inferiority tests were applied.ResultsSC-TF-CBT participants changed at rates comparable to participants in TF-CBT for primary and secondary measures. SC-TF-CBT was non-inferior to TF-CBT for PTSS, impairment, and severity at all time points except for impairment at the 6-month assessment. Attrition did not differ between treatment arms (132 participants were completers). Baseline treatment acceptability was lower for SC-TF-CBT parents, although there was no difference in expected treatment improvements or treatment satisfaction at posttreatment. Based on regression estimates, total costs were 38.4% lower for SC-TF-CBT compared to TF-CBT, whereas recurring costs were 53.7% lower.ConclusionStepped Care TF-CBT provides an alternative way to deliver treatment for some children and parents, with reduced cost for providers and parents.Clinical trial registration informationStepped Care for Children after Trauma: Optimizing Treatment; https://clinicaltrials.gov; NCT02537678.

Project description:To undertake the first randomized controlled trial to evaluate the effectiveness of a brief intervention delivered by community pharmacists to reduce hazardous or harmful drinking.This parallel group randomized trial allocated participants individually to brief alcohol intervention (n?=?205) or a leaflet-only control condition (n?=?202), with follow-up study after 3 months.Sixteen community pharmacies in one London Borough, UK.A total of 407 pharmacy customers (aged 18?years or over) with Alcohol Use Disorder Identification Test (AUDIT) scores 8-19, inclusive.A brief motivational discussion of approximately 10 minutes' duration, for which 17 pharmacists received a half-day of training.Hazardous or harmful drinking was assessed using the AUDIT administered by telephone by a researcher blind to allocation status. The two primary outcomes were: (1) change in AUDIT total scores and (2) the proportions no longer hazardous or harmful drinkers (scoring <?8) at 3?months. The four secondary outcomes were: the three subscale scores of the AUDIT (for consumption, problems and dependence) and health status according to the EQ-5D (a standardized instrument for use as a measure of health outcome).At 3 months 326 (80% overall; 82% intervention, 78% control) participants were followed-up. The difference in reduction in total AUDIT score (intervention minus control) was -0.57, 95% confidence interval (CI)?=?-1.59 to 0.45, P?=?0.28. The odds ratio for AUDIT ??8 (control as reference) was 0.87, 95% CI?=?0.50 to 1.51, P?=?0.61). For two of the four secondary outcomes (dependence score: -0.46, 95% CI?=?-0.82 to -0.09, P?=?0.014; health status score: -0.09, 95% CI?=?-0.16 to -0.02, P?=?0.013) the control group did better, and in the other two there were no differences (consumption score: -0.05, 95% CI?=?-0.54 to 0.44, P?=?0.85; non-dependence problems score: -0.13, 95% CI?=?-0.66 to 0.41). Sensitivity analyses did not change these findings.A brief intervention delivered by community pharmacists appears to have had no effect in reducing hazardous or harmful alcohol consumption.

Project description:Background:There is lack of ideal and comprehensive economic evaluations of various GDM strategies. The aim of this study is to the compare efficacy and cost-effectiveness of five different methods of screening for gestational diabetes mellitus (GDM). Methods:This study is a randomized community non-inferiority trial among 30,000 pregnant women in five different geographic regions of Iran, who were randomly assigned to one of the five GDM screening methods. All first trimester pregnant women, seeking prenatal care in governmental health care systems, who met our eligibility criteria were enrolled. The criteria suggested by the International-Association-of-Diabetes-in-Pregnancy-Study-Group, the most intensive approach, were used as reference. We used the non-inferiority approach to compare less intensive strategies to the reference one. Along with routine prenatal standard care, all participants were scheduled to have two phases of GDM screening in first and second-trimester of pregnancy, based on five different pre-specified protocols. The screening protocol included fasting plasma glucose in the first trimester and either a one step or a two-step screening method in the second trimester of pregnancy. Pregnant women were classified in three groups based on the results: diagnosed with preexisting pre-gestational overt diabetes; gestational diabetes and non-GDM women. Each group received packages for standard-care and all participants were followed till delivery; pregnancy outcomes, quality of life and cost of health care were recorded in detail using specific standardized questionnaires. Primary outcomes were defined as % birth-weight?>?90th percentile and primary cesarean section. In addition, we assessed the direct health care direct and indirect costs. Results:This study will enable us to compare the cost effectiveness of different GDM screening protocols and intervention intensity (low versus high). Conclusion:Results which if needed, will also enable policy makers to optimize the national GMD strategy as a resource for enhancing GDM guidelines.Trial registration Name of the registry: Iranian Registry of Clinical Trials. Trial registration number: IRCT138707081281N1. Date of registration: 2017-02-15. URL of trial registry record: https://www.irct.ir/trial/518.

Project description:BackgroundThe transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery.MethodsThis was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively.Results60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0-4.5] UTAP vs. 0 [0-8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8-17.1] UTAP vs. 3.6 [0-12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5-70.2] UTAP vs. 22.2 [7.5-63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.ConclusionsSurgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.Trial registryThe trial was registered at clinicaltrials.gov Identifier NCT03577912.

Project description:Volatile anesthetics possess cardioprotective properties, but it is unknown if the cardioprotective effects extend equally to all members of the class. Although sevoflurane is a relatively newer anesthetic than isoflurane, its introduction into practice was not preceded by a head-to-head comparison with isoflurane in a trial focusing on clinically important outcomes. Our objective was to determine whether sevoflurane was non-inferior to isoflurane on a clinically important primary outcome in a heterogeneous group of adults undergoing cardiac surgery.This was a pragmatic randomized non-inferiority comparative effectiveness clinical trial in 464 adults having coronary artery bypass graft and/or single valve surgery during November 2011 to March 2014. The intervention was maintenance of anesthesia with sevoflurane (n = 231) or isoflurane (n = 233) administered at a dose of 0.5-2.0 MAC throughout the entire operation. All caregivers were blinded except for the anesthesiologist and perfusionist. The primary outcome was a composite of intensive care unit (ICU) length of stay ? 48 hr and all-cause 30-day mortality. We hypothesized that sevoflurane would be non-inferior to isoflurane (non-inferiority margin < 10% based on an expected event rate of 25%). Secondary outcomes included prolonged ICU stay, 30- and 365-day all-cause mortality, inotrope or vasopressor usage, new-onset hemodialysis or atrial fibrillation, stroke, and readmission to the ICU.No losses to follow-up occurred. The primary outcome occurred in 25% of sevoflurane patients and 30% of isoflurane patients (absolute difference, -5.4%; one-sided 95% confidence interval, 1.4), thus non-inferiority was declared. Sevoflurane was not superior to isoflurane for the primary outcome (P = 0.21) or for any secondary outcomes.Sevoflurane is non-inferior to isoflurane on a composite outcome of prolonged ICU stay and all-cause 30-day mortality. Sevoflurane is not superior to isoflurane on any other of the clinically important outcomes. This trial was registered at clinicaltrials.gov; NCT01477151.

Project description:BackgroundThe lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers.MethodsWe will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode.DiscussionThis trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC.Trial registrationThe trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.

Dataset Information

Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial.

Publications

Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial.

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