Implementation of an online pragmatic randomized controlled trial: a methodological case study.
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ABSTRACT:
SUBMITTER: Cobb NK
PROVIDER: S-EPMC3771016 | biostudies-literature | 2013 Sep
REPOSITORIES: biostudies-literature
Publications
Implementation of an online pragmatic randomized controlled trial: a methodological case study.
Cobb Nathan K NK Poirier Josée J
Translational behavioral medicine 20130901 3
Rigorous evaluation of eHealth interventions is acutely needed but can be challenging to execute in a cost- and time-efficient way. The purpose of this study is to describe a randomized controlled trial carried out as part of an approach that evaluates and informs product development throughout an intervention's life cycle. We present the methodological case of a pragmatic randomized controlled trial evaluating the effectiveness of the web-based intervention "Daily Challenge." We conducted the t ...[more]
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Project description:Background and objectivesThe Changing Talk (CHAT) communication training effectively reduces elderspeak and subsequent behavioral challenges in residents with dementia in nursing homes (NHs). As part of the pilot pragmatic clinical trial testing Changing Talk: Online Training (CHATO), a new online version, a remote implementation design, and process evaluation were developed to capture contextual factors, ensure fidelity, and determine effective implementation strategies.Research design and methodsThe Expert Recommendation for Implementing Change compilation informed this 2-phase approach to develop and test remote implementation. An Advisory Board guided the developmental phase while pilot testing used a cluster-randomized design. Data were analyzed to evaluate NH characteristics; implementation strategies used; CHATO participation, completion, and passing rates; and leadership evaluation.ResultsFive out of 7 NHs were nonprofit with above average quality ratings (M = 4.3 of 5). Staff participants (N = 237) were mostly female (90%), non-Hispanic White (91%), and nursing assistants (46%). Implementation time ranged from 54 to 86 days (M = 70.3, standard deviation [SD] = 9.3), with planning phase ranging from 11 to 29 days (M = 20.1, SD = 6.7), and training phase ranging from 35 to 58 days (M = 50.0, SD = 7.6). A range from 3 to 11 implementation strategies were used by each NH. Assigning champions, including the social worker on the implementation team, utilizing multiple mediums for reminders, giving rewards or public recognition, supporting onsite discussions, and other tailoring strategies were associated with improved outcomes. Participation ranged from 20% to 76%. Over 63% of participants completed training (N = 150) and 87% passed the posttest (N = 130). Leadership evaluations noted staff used CHATO concepts in practice and improved communication culture.Discussion and implicationsLeadership who took an active role, engaged multiple team members, and varied strategies had better outcomes. Effectiveness of the strategies will be evaluated in a national pragmatic clinical trial testing CHATO's effects on reducing behavioral and psychological symptoms in dementia care.
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Project description:The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures.A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life.The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P?<?0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P?<?0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group.We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.
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Project description:Background and aimsSustained psychosocial support via online social groups may help former tobacco users maintain abstinence. This study aims to examine the effectiveness of participating in a WhatsApp social group for long-term smoking cessation.DesignTwo-arm, open-labelled, pragmatic, individually randomized controlled trial.SettingAll participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones.ParticipantsParticipants included 1008 adult quitters who self-report no tobacco use in the past 3-30 days.InterventionsThe intervention group (n = 504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones. All social groups will be led by counselors or specialist nurse practitioners. The control group (n = 504) will receive similar reminders via short messages to their own mobile phones but will not interact with other participants. The intervention duration for both groups is 8 weeks. Both groups will receive a booklet at baseline about how to prevent smoking relapse.MeasurementsThe primary outcome is biochemically validated tobacco abstinence at 12 months after consent.CommentsThe findings will provide evidence concerning the utility of operating online social group discussion for prevention of smoking relapse and sustaining long-term abstinence.
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Project description:Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm (n = 200) or the control arm (n = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant (p < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.
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Project description:BackgroundCisplatin is one of the most potent chemotherapeutic drugs used in head and neck cancer treatment; however, nephrotoxicity is the major side-effect limiting usage. Magnesium supplementation has been reported to reduce risk in non-controlled studies. We investigated whether preloading with magnesium prevents nephrotoxicity with a low-dose weekly cisplatin regimen.MethodsWe carried out a prospective pilot, single-blinded, randomized controlled trial to compare cisplatin-associated acute kidney injury (cis-AKI) and acute kidney disease (cis-AKD) between two groups: intravenous 0.9% NaCl 500 ml + KCL 20 mEq over 4 h pre-cisplatin 40 mg/m2 weekly for 7-8 weeks (control group) compared with additional 16 mEq magnesium added to the saline infusion (Mg group) in 30 head and neck cancer patients. Cis-AKI was defined as an increased serum creatinine (SCr) ≥ 0.3 mg/dl within 7 days and cis-AKD is an increased SCr ≥ 0.3 mg/dl between last SCr and baseline pre-chemotherapy SCr.ResultsThe overall cisplatin tumor response rate and survival were comparable between groups. The baseline characteristics were comparable between groups, although SCr was lower in the controls (0.70 ± 0.17 versus 0.87 ± 0.17 mg/dl, P = 0.01). The incidence of cis-AKI was similar (4.6% versus 1.3%); however, the incidence of cis-AKD was higher for the control group (46.7% versus 6.7%, hazard ratio = 0.082, 95% confidence interval 0.008-0.79, P = 0.03). The time to develop cis-AKD was significantly shorter in the control group (P = 0.007).ConclusionsThe magnesium-preloading regimen was safe and significantly showed a decreased incidence of cis-AKD. The encouraging results of our pilot study need to be confirmed in a large-scale randomized controlled trial.
| S-EPMC8717436 | biostudies-literature
Project description:Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N?=?55) or usual care group (UC: N?=?55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.
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Project description:BACKGROUND:Disordered eating (DE) is a widespread, serious problem. Efficacious prevention programs that can be delivered at-scale are needed. METHODS:A pragmatic randomized controlled trial of two online programs was conducted. Participants were young-adult women from Australia and New Zealand seeking to improve their body image. Media Smart-Targeted (MS-T) and Student Bodies (SB) were both 9-module interventions released weekly, whilst control participants received positive body image information. Primary [Eating Disorder Examination-Questionnaire (EDE-Q) Global], secondary (DE risk factors) and tertiary (DE) outcome measures were completed at baseline, post-program, 6- and 12-month follow-up. RESULTS:Baseline was completed by 608 women (M age = 20.71 years); 33 were excluded leaving 575 randomized to: MS-T (N = 191); SB (N = 190) or control (N = 194). Only 66% of those randomized to MS-T or SB accessed the intervention and were included in analyses with controls; 78% of this sample completed measures subsequent to baseline. Primary intent-to-treat (ITT) analyses revealed no differences between groups, while measure completer analyses found MS-T had significantly lower EDE-Q Global than controls at 12-month follow-up. Secondary ITT analyses found MS-T participants reported significantly higher quality of life-mental relative to both SB and controls (6-month follow-up), while MS-T and controls had lower clinical impairment relative to SB (post-program). Amongst measure completers, MS-T scored significantly lower than controls and SB on 5 variables. Of those with baseline DE, MS-T participants were significantly less likely than controls to have DE at 12-month follow-up. CONCLUSIONS:Given both programs were not therapist-moderated, MS-T has potential to achieve reductions in DE risk at low implementation costs.
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Project description:BackgroundFalls remain the leading cause of injury, long-term disability, premature institutionalization, and injury-related mortality in the older adult population. Home modifications, when delivered by occupational therapists, can reduce falls among high-risk community-dwelling older adults by 39%. However, home-modification implementation is not standard practice in the United States. The goal of the Home Hazard Removal Program (HARP) study is to implement an evidence-based home modification intervention for older adults designed to reduce the incidence of falls through an aging services network.MethodsWe will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who are randomized and followed for 12 months. Participants who are randomized to treatment will receive the home modification intervention provided by an occupational therapist in addition to usual care, defined as continued services from the area agency on aging. We will compare the effectiveness of the program and usual care using survival analysis with the time to the first fall over 12 months as the primary outcome of interest. Secondary outcomes include daily activity performance, fall self-efficacy, and health-related quality of life. Fidelity, dose, adherence, safety, cost, and health care utilization will also be examined in the implementation component of this study.DiscussionThis intervention targets an underserved, difficult to reach population of older adults. The tailored approach of the study intervention is a strength in improving adherence, as each recommendation is individualized to be acceptable to the participant. The effectiveness/implementation design of the study allows for rapid dissemination of results and implementation of the intervention in a United States social services agency.Trial registrationClinicaltrials.gov identifier: NCT02392013 . Retrospectively registered on March 5, 2015.
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Project description:BackgroundDespite US naloxone access laws, community pharmacists lack training and confidence in providing naloxone.ObjectiveTo assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as naloxone prescriptions dispensed.MethodsA 3-month pragmatic randomized controlled trial was conducted from December 2018 to March 2019. Alabama community pharmacists were recruited by mail, email, phone, and fax and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly reminders only). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3), including naloxone knowledge (%correct); perceived barriers, attitudes, confidence, and intention regarding naloxone services implementation (7-point Likert-type scale; 1 = strongly disagree, 7 = strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention from T1 to T3 were assessed using 2-way mixed analysis of variance and adjusted analyses were conducted using generalized estimating equations with negative binomial distribution to assess associations between variables.ResultsOf 55 participants (n = 27 intervention, n = 28 control), most were female (80.3%), white (80.6%), in independently owned pharmacies (39.1%). Increases in mean [SD] confidence (5.52 [1.03]-6.16 [0.74], P < 0.0005) and intention (5.35 [1.51]-6.10 [0.96], P = 0.023) occurred from pre- to post-program within the intervention group and were statistically significant compared with control (confidence P = 0.016, intention P = 0.014). Confidence (exp(β) = 1.46, P = 0.031) and perceived barriers (exp(β) = 0.75, P = 0.022) were associated with number of naloxone prescriptions dispensed.Conclusion and relevanceThe Empowering Community Pharmacists program improved community pharmacists' confidence and intention regarding naloxone services implementation. Other states can adapt program elements according to their laws.Clinicaltrials.gov identifierNCT05093309.
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Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).
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