scholarly journals Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ellen M. McCreedy ◽  
Roee Gutman ◽  
Rosa Baier ◽  
James L. Rudolph ◽  
Kali S. Thomas ◽  
...  
Keyword(s):  
Nursing Home ◽  
Real World ◽  
Implementation Strategies ◽  
Trial Registration ◽  
World Health ◽  
Secondary Outcome ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact ◽  
Adaptive Trial

Abstract Background Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. Methods We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents’ racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. Discussion This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2a} Trial registration ClinicalTrials.govNCT03821844. Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.

scholarly journals The 4MOTHERS trial of the impact of a mobile money-based intervention on maternal and neonatal health outcomes in Madagascar: study protocol of a cluster-randomized hybrid effectiveness-implementation trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Etienne Lacroze ◽  
Till Bärnighausen ◽  
Jan Walter De Neve ◽  
Sebastian Vollmer ◽  
Rolland Marie Ratsimbazafy ◽  
...  
Keyword(s):  
Antenatal Care ◽  
Health Outcomes ◽  
Sub Saharan Africa ◽  
Trial Registration ◽  
World Health ◽  
Neonatal Health ◽  
Mobile Money ◽  
Maternal And Neonatal Health ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Mobile money—a service enabling users to receive, store, and send electronic money using mobile phones—has been widely adopted across low- and middle-income economies to pay for a variety of services, including healthcare. However, evidence on its effects on healthcare access and health outcomes are scarce and the possible implications of using mobile money for financing and payment of maternal healthcare services—which generally require large one-time out-of-pocket payments—have not yet been systematically assessed in low-resource settings. The aim of this study is to determine the impact on health outcomes, cost-effectiveness, feasibility, acceptability, and usefulness of mobile phone-based savings and payment service, the Mobile Maternal Health Wallet (MMHW), for skilled healthcare during pregnancy and delivery among women in Madagascar. Methods This is a hybrid effectiveness-implementation type-1 trial, determining the effectiveness of the intervention while evaluating the context of its implementation in Madagascar’s Analamanga region, containing the capital, Antananarivo. Using a stratified cluster randomized design, 61 public-sector primary-care health facilities were randomized within 6 strata to either receive the intervention or not (29 intervention vs. 32 control facilities). The strata were defined by a health facility’s antenatal care visit volume and its capacity to offer facility-based deliveries. The registered pre-specified primary outcomes are (i) delivery at a health facility, (ii) antenatal care visits, and (iii) total healthcare expenditure during pregnancy, delivery, and neonatal period. The registered pre-specified secondary outcomes include additional health outcomes, economic outcomes, and measurements of user experience and satisfaction. Our estimated enrolment number is 4600 women, who completed their pregnancy between July 1, 2020, and December 31, 2021. A series of nested mixed-methods studies will elucidate client and provider perceptions on feasibility, acceptability, and usefulness of the intervention to inform future implementation efforts. Discussion A cluster-randomized, hybrid effectiveness-implementation design allows for a robust approach to determine whether the MMHW is a feasible and beneficial intervention in a resource-restricted public healthcare environment. We expect the results of our study to guide future initiatives and health policy decisions related to maternal and neonatal health and universal healthcare coverage through technology in Madagascar and other countries in sub-Saharan Africa. Trial registration This trial was registered on March 12, 2021: Deutsches Register Klinischer Studien (German Clinical Trials Register), identifier: DRKS00014928. For World Health Organization Trial Registration Data Set see Additional file 1.

scholarly journals Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Nadja Kehler Curth ◽  
Ursula Brinck-Claussen ◽  
Kirstine Bro Jørgensen ◽  
Susanne Rosendal ◽  
Carsten Hjorthøj ◽  
...  
Keyword(s):  
Collaborative Care ◽  
Well Being ◽  
World Health ◽  
Secondary Outcome ◽  
Depression Symptoms ◽  
Short Term ◽  
Positive Effects ◽  
Link Type ◽  
Cluster Randomized

Abstract Background Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3 months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials. Methods Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected. Discussion The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark. Trial registration ClinicalTrials.gov, NCT03113175 and NCT03113201. Registered on 13 April 2017.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Coadministration of tizanidine and ciprofloxacin: a retrospective analysis of the WHO pharmacovigilance database

2021 ◽  
Author(s):  
Annette Rudolph ◽  
Hendrike Dahmke ◽  
Hugo Kupferschmidt ◽  
Andrea Burden ◽  
Stefan Weiler
Keyword(s):  
Real World ◽  
Safety Issue ◽  
Demographic Data ◽  
Fatal Outcome ◽  
Individual Case ◽  
World Health ◽  
Global Database ◽  
The Usa ◽  
Pharmacovigilance Database ◽  
The Impact

Abstract Purpose Tizanidine, an alpha-adrenergic substance with antinociceptive and antihypertensive effects, is extensively metabolized via cytochrome P450 (CYP) 1A2. Therefore, coadministration with potent CYP1A2 inhibitors, such as ciprofloxacin, is contraindicated. However, both drugs are broadly utilized in various countries. Their concomitant use bears an inherent high risk for clinically significant symptoms, especially in multimorbid patients experiencing polypharmacy. This study aims to investigate the impact of coadministration of tizanidine and ciprofloxacin using real-world pharmacovigilance data and to raise awareness of this potentially underestimated safety issue. Methods We conducted a retrospective study including Individual Case Safety Reports (ICSR) registered until March 1, 2017, in the World Health Organization (WHO) global database. Demographic data, drug administration information, the course of the adverse drug reaction (ADR), its severity, and outcomes were analyzed for cases reporting ciprofloxacin comedication. Results In 91 (2.0%) of the identified 4192 worldwide ICSR on tizanidine, coadministration of ciprofloxacin was reported. Most of the patients were female (n = 59, 64.8%) with a median age of 54 years (range 13–85 years). The countries contributing most reports were the USA (n = 54, 59.3%) and Switzerland (n = 16, 17.6%). ADRs reported most often affected the nervous system and the cardiac function, especially with large tizanidine doses or drugs with CNS and cardiovascular depressant effects. In two cases, a fatal outcome was reported. Conclusion Despite the existing formal contraindication, the concomitant use of tizanidine and ciprofloxacin can be observed in real-world clinical practice. Reactions mainly affected the central nervous and the cardiovascular system resulting in potentially severe adverse effects. The concomitant use of tizanidine and ciprofloxacin should absolutely be avoided.

scholarly journals Evaluating the effectiveness of incentives to improve HIV prevention outcomes for young females in Eswatini: Sitakhela Likusasa impact evaluation protocol and baseline results

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marelize Gorgens ◽  
Andrew F. Longosz ◽  
Sosthenes Ketende ◽  
Muziwethu Nkambule ◽  
Tengetile Dlamini ◽  
...  
Keyword(s):  
Adolescent Girls ◽  
Young Women ◽  
Impact Evaluation ◽  
Trichomonas Vaginalis ◽  
Trial Registration ◽  
Baseline Survey ◽  
Young Females ◽  
Link Type ◽  
Cash Incentive ◽  
The Impact

Abstract Background Eswatini continues to have the highest prevalence of HIV in the world, and one of the highest HIV incidences among adult populations (aged 15–49). This analysis reports on both key elements of study design/protocol and baseline results from an impact evaluation of an intervention incentivizing (i) initiation, enrolment, attendance or completion of some form of education, and (ii) lower risk sexual behaviour. Methods The impact evaluation employs a two by two factorial design in which participants are enrolled in either the incentive for education arm (‘education treatment arm’ providing a conditional cash incentive) or the control arm (‘education control arm’). In each of these arms, 50% of participants were randomized to also be eligible for selection – three times a year – to participate in a conditional raffle conditional on testing negative for curable STIs (syphilis and Trichomonas vaginalis). Results Baseline recruitment and screening occurred in 2016 when a total of 6055 individuals were screened of which 4863 participated in the baseline survey, and 4819 individuals were randomized into one of the study arms. The baseline prevalence of HIV, Trichomonas vaginalis, and syphilis among adolescent girls and young women 8.20% (397/4840), 3.31% (150/4533) and 0.17% (8/4830) respectively. Conclusions An educational cash incentive and raffle incentive impact evaluation that addresses adolescent girls and young women who are in-education and out-of-education has the potential to reduce HIV risk in adolescent girls and young women in Eswatini. Trial registration Name of the registry: Pan African Clinical Trials Registry. Trial registration number: PACTR201811609257043. Date of registration: May 11, 2018 ‘Retrospectively registered’. URL of trial registry record: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=4685

scholarly journals The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
morgane guillou-landreat ◽  
Elkhan Tahmazov ◽  
Schreck Benoit ◽  
Marie Grall-bronnec ◽  
Patricia Conrod ◽  
...  
Keyword(s):  
Personality Traits ◽  
Binge Drinking ◽  
Sensation Seeking ◽  
Alcohol Intoxication ◽  
Trial Registration ◽  
Prevention Programme ◽  
Control Group ◽  
Targeted Prevention ◽  
Link Type ◽  
The Impact

Abstract Background Alcohol use is a major public health challenge in France, where at the age of 17 half the young people report an episode of severe alcohol intoxication in the month preceding the survey. Numerous prevention programmes have a general objective, but in adolescence individual vulnerabilities towards addictions differ significantly with personality traits. Prevention targeting personality traits enables work on risk factors for addictive behaviours, and has shown genuine efficacy. Among existing programmes, PREVENTURE has shown an effect on the reduction in alcohol consumption by targeting four personality traits: impulsivity, sensation-seeking, negative thoughts and anxiety. This programme has been tested on samples recruited in adolescent populations in school environments, identifying adolescents at risk, but it has not been tested on a more targeted recruitment of adolescents seen in consultation. Methods The main hypothesis of this study is that the targeted prevention programme PREVENTURE will have an impact on the prevalence of binge-drinking episodes. The secondary hypotheses explore other factors such as associated substance use, anxiety and depression, as well as the acceptability of the programme. This article presents the study protocol of “PREVADO” study. We intend to assess the impact of the targeted intervention programme PREVENTURE on the prevalence of binge-drinking episodes among adolescents aged 14 to 17 years consulting in one of the participating centres or referred by a school doctor. The study will be prospective, randomised, controlled and open-label, and will comprise an intervention group and a control group. The adolescents will then be followed and assessed 1, 3, 6 and 12 months after the intervention. The study needs to include 700 subjects in order to reach 340 adolescents randomised, 170 in each group. It will concern 33 centres. Discussion This project could favour the targeting of addictive behaviours among vulnerable adolescents, and its application on a larger scale could be envisaged. Trial registration The Trial registration number is NCT04599270, and it was registered on the ClinicalTrials.gov public website.

scholarly journals Adolescent to Adult Patient-centered HIV Transition (ADAPT): Study Protocol for a Cluster Randomized Trial

2019 ◽  
Author(s):  
Ernest Ekong ◽  
Chidozie Edokwe ◽  
Christopher Isah ◽  
Ashley Shutt ◽  
Manhattan Charurat ◽  
...  
Keyword(s):  
Cluster Randomized Trial ◽  
Healthcare Services ◽  
Secondary Outcome ◽  
Positive Health ◽  
Adult Care ◽  
Successful Transition ◽  
Network Analyses ◽  
Starting Point ◽  
Cluster Randomized ◽  
The Impact

Abstract Background: Innovative strategies and protocols are required for effective provision of healthcare services and attainment of optimal positive health outcomes for adolescents living with HIV (ALHIV) as they transition to adult care.HIV-infected youth must learn to navigate a complex healthcare system as they transition from pediatric to adult care. Poorly planned transitions can result in non-adherence to ART, loss-to-follow-up in care and supportive services, with resultant negative health impact. This study evaluates two different approaches to the process of transition from pediatric to adult care in six facilities in Nigeria. Methods: ADAPT will use a cluster randomized intervention trial to measure the impact of Peer Transition Advocates (PTAs) versus Education Interventionists (EIs) approach to the process of transition of ALHIV, with imbedded psychosocial/social network analyses. The study will be conducted in 6 healthcare facilities (three tertiary and three secondary) in Northern and Central Nigeria. The unit of randomization (cluster) will be the facilities (n=180 per intervention arm, N=360), study participants 17-19 year-old ALHIV enrolled in the pediatric ART clinic for ≥12 months and know their HIV status. Sixty participants will be recruited pre-transition per site and followed up 12 months post-transition. Primary outcome measure will be proportion of ALHIV achieving successful transition and viral suppression 12 months post-transition comparing the two arms. Secondary outcome measures are proportion of ALHIV achieving ownership of care, improved quality of life, better transfer experience, and social support system measured by individual and ego-network evaluation tools correlating with successful transition. Discussion: ADAPT hypothesizes that by involving ALHIV in the study design, the PTA intervention will result in more successful transition and clinical outcomes in adult care. Further, we postulate that properly trained and supervised task-oriented peer support using lay workers assigned to track and guide each adolescent along the transition pathway in the clinic and in the community is the key starting point for transforming a dysfunctional system. Findings from ADAPT will guide institutions on best practices for transitioning ALHIV and other adolescents with chronic conditions in Nigeria and other resource-limited settings.

scholarly journals Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mihaela S. Stefan ◽  
Penelope S. Pekow ◽  
Christopher M. Shea ◽  
Ashley M. Hughes ◽  
Nicholas S. Hill ◽  
...  
Keyword(s):  
Study Design ◽  
Noninvasive Ventilation ◽  
Implementation Strategies ◽  
Inpatient Setting ◽  
Effectiveness Trial ◽  
Copd Exacerbation ◽  
Implementation Effectiveness ◽  
Link Type ◽  
The Impact ◽  
Severe Copd

Abstract Background There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Yet, several studies have demonstrated substantial variation in NIV use across hospitals, leading to preventable morbidity and mortality. In addition, prior studies suggested that efforts to increase NIV use in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, our initial project aimed to compare two educational strategies: online education (OLE) and interprofessional education (IPE), which targets complex team-based care in NIV delivery. Due to the impact of the COVID-19 pandemic on recruitment and planned intervention, we had made several changes in the study design, statistical analysis, and implementation strategies delivery as outlined in the methods. Methods We originally proposed a two-arm, pragmatic, cluster, randomized hybrid implementation-effectiveness trial comparing two education strategies to improve NIV uptake in patients with severe COPD exacerbation in 20 hospitals with a low baseline rate of NIV use. Due to logistical constrains and slow recruitment, we changed the study design to an opened cohort stepped-wedge design with three steps which will allow the institutions to enroll when they are ready to participate. Only the IPE strategy will be implemented, and the education will be provided in an online virtual format. Our primary outcome will be the hospital-level risk-standardized NIV proportion for the period post-IPE training, along with the change in rate from the period prior to training. Aim 1 will compare the change over time of NIV use among patients with COPD in the step-wedged design. Aim 2 will explore the mediators’ role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and effectiveness. Finally, in Aim 3, through interviews with providers, we will assess the acceptability and feasibility of the educational training. Conclusion The changes in study design will result in several limitation. Most importantly, the hospitals in the three cohorts are not randomized as they enroll based on their readiness. Second, the delivery of the IPE is virtual, and it is not known if remote education is conducive to team building. However, this study will be among the first to test the impact of IPE in the inpatient setting carefully and may generalize to other interventions directed to seriously ill patients. Trial registration ClinicalTrials.govNCT04206735. Registered on December 20, 2019;

scholarly journals Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Deborah E. Polk ◽  
Erick G. Guerrero ◽  
Inga Gruß ◽  
Nilesh H. Shah ◽  
Nadia M. Yosuf ◽  
...  
Keyword(s):  
Implementation Strategies ◽  
Cluster Randomized Trial ◽  
Background Information ◽  
Evidence Based ◽  
Stepped Wedge ◽  
Link Type ◽  
Dental Clinics ◽  
Occlusal Surfaces ◽  
Cluster Randomized ◽  
General Dentists

Abstract Background The American Dental Association (ADA) recommends dental providers apply dental sealants to the occlusal surfaces of permanent molars for the prevention or treatment of non-cavitated dental caries. Despite the evidence-based support for this guideline, adherence among general dentists is low, ranging from less than 5 to 38.5%. Thus, an evidence-to-practice gap exists, and it is unclear which implementation strategies would best support providers in adopting and implementing the evidence-based practice. One potential approach to selecting and tailoring implementation strategies is a deliberative loop process, a stakeholder-engaged approach to decision-making. This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice. Methods Sixteen dental clinics within Kaiser Permanente Northwest Dental will be cluster randomized to determine the timing of receiving the intervention in this stepped-wedge trial. In the three-part deliberative loop intervention, clinic stakeholders engage in the following activities: (1) receive background information, (2) participate in facilitated small-group discussions designed to promote learning from each other’s lived experiences and develop informed opinions about effective clinic-level implementation strategies, and (3) share their informed opinions with clinic leaders, who may then choose to select and deploy implementation strategies based on the stakeholders’ informed opinions. The primary outcome of Reach will be defined as patient-level receipt of guideline-concordant care. Secondary outcomes will include the cost-effectiveness, acceptability, and feasibility of the deliberative loop process. Implementation strategies deployed will be catalogued over time. Discussion These results will establish the extent to which the deliberative loop process can help leaders select and tailor implementation strategies with the goal of improving guideline-concordant dental care. Trial registration This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730

scholarly journals Effect of Varying Repositioning Frequency on Prevention of Pressure Injuries in Nursing Home Residents: TEAM‐UP Cluster‐Randomized Clinical Trial Results

2021 ◽  
Author(s):  
Tracey L. Yap ◽  
Susan D. Horn ◽  
Phoebe D. Sharkey ◽  
Tianyu Zheng ◽  
Nancy Bergstrom ◽  
...  
Keyword(s):  
Nursing Home ◽  
Controlled Trial ◽  
Institutional Care ◽  
Nursing Home Residents ◽  
Clinical Effectiveness ◽  
Risk Scores ◽  
Secondary Outcome ◽  
Effective Sample Size ◽  
Injury Incidence ◽  
Cluster Randomized

Abstract Background: Pressure injuries (PrIs) cause pain and infection, lengthen institutional care, raise healthcare costs, and hasten death in nursing home (NH) residents. Repositioning residents to offload pressure on tissues is the most common prevention strategy, yetthe optimal interval remains uncertain.Objective: Investigate clinical effectiveness of three nursing-home-wide repositioning intervals (2-,3-, or 4-hours) without compromising PrI incidence in four weeks in adult nursing home residents.Design, Setting, and Participants: Anembedded pragmatic cluster randomized controlled trial was conducted in 9 NHs from a large proprietary system located in 34 states. Each NH was randomly assigned to one of three NH-wide repositioning interval Arms (every 2, 3, or 4 hours). Data were provided for 12-month Baseline and 4-week Intervention during the Turn Everyone And Move for Ulcer Prevention (TEAM-UP) study. Intervention residents were without current PrIs, had PrIrisk (Braden Score) ≥10 (low, mild, moderate, or high risk; not severe risk), and used viable 7” high-density foam mattresses.Methods: Each Arm included three NHs with assigned single repositioning interval as standard care during the 4-week Intervention. Mandatory staff education sessions were provided.A wireless patient monitoring system, using wearable single-use patient sensors, cued staff by displaying resident repositioning need on conveniently placed monitors.Primary outcome was PrI incidence; secondary outcome was staff repositioning compliance fidelity.Results: Eleven hundred residents from 9 NHs were fitted with sensors; 108 of these were ineligible for some analyses due to missing Baseline data. Effective sample size included 992 residents (mean age 78 years [SD13]; 63% female). Pressure injury incidence during the Intervention was 0.0% compared to 5.24% in Baseline, even though Intervention resident clinical risk scores were significantlyhigher (p<0.001). Repositioning compliance for 4-hour repositioning interval (95%) was significantly better than 2- (80%) or 3- (90%) hours (p<.001).Conclusions: This study contributes to understanding alternativerepositioning intervalssuggestingcurrent 2-hour protocolscan be relaxed for many without compromising PrI development. Causal link was not established between three repositioning interval treatments and primary outcome—PrIs; however, no new PrIs developed. Cueing staff may benefit repositioningimplementation; compliance improved as repositioning interval lengthened.Trial Registration: (ClinicalTrials.gov Identifier: NCT02996331).Date: 16/05/2017

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