A cluster randomized trial of a patient-centered communication intervention in advanced cancer: The Values and Options In Cancer Care (VOICE) study.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
Joshua J Fenton ◽  
Richard L Kravitz ◽  
Paul Duberstein ◽  
Daniel J Tancredi ◽  
Guibo Xing ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Communication Training ◽  
Community Dwelling ◽  
Patient Centered ◽  
Hematologic Cancer ◽  
Coaching Intervention ◽  
Secondary Outcomes ◽  
Cluster Randomized

2 Background: Observational studies demonstrate links between patient-centered communication, prognosis discordance, quality of life (QoL) and aggressive treatments near the end of life, yet there are few randomized evaluations of communication interventions in advanced cancer. Methods: We completed a cluster randomized controlled trial in cancer clinics in Western NY and Northern CA with medical oncologists (n = 38 randomized to intervention or control) and their community-dwelling adult patients with advanced non-hematologic cancer (n = 265; 194 with enrolled caregivers). Interventions foroncologists (individualized communication training using Standardized Patient Instructors) and patients/caregivers (individualized coaching using question prompt lists) were directed towards enhancing patient engagement in consultations, oncologists’ response to emotions, and provision of balanced information about prognosis and treatment choices. Oncologists and patients randomized to control received no interventions. Primary outcome was a composite of 4 communication measures coded from audio-recorded oncologist visits shortly after patient coaching (intervention) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QoL, and utilization of aggressive treatments and hospice in the last 30 days of life. Results: In fully-adjusted models, the intervention significantly improved mean composite communication scores [0.34, 95% CI (0.06, 0.62), p = 0.017]. Effects on secondary outcomes were not significant. Conclusions: Oncologist communication training combined with coaching for patients with advanced cancer and available caregivers promoted patient-centered communication. Nevertheless, we did not observe changes in QoL and utilization, suggesting that more intensive, psychologically-oriented or longitudinal interventions may be needed, along with support and incentives for clinicians to participate. Clinical trial information: NCT01485627.

scholarly journals Effects of Live Music Therapy on Autonomic Stability in Preterm Infants: A Cluster-Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1077
Author(s):  
Dana Yakobson ◽  
Christian Gold ◽  
Bolette Daniels Beck ◽  
Cochavit Elefant ◽  
Sofia Bauer-Rusek ◽  
...  
Keyword(s):  
Music Therapy ◽  
Preterm Infants ◽  
Stress Responses ◽  
Emotional Development ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Study Groups ◽  
Outcome Variable ◽  
Secondary Outcomes ◽  
Cluster Randomized

Unbuffered stress levels may negatively influence preterm-infants’ autonomic nervous system (ANS) maturation, thus affecting neurobehavior and psycho-emotional development. Music therapy (MT) is an evidence-based treatment modality in neonatal care. When coupled with skin-to-skin care (SSC), it may reduce stress responses in both preterm infants and their parents and enhance family-centered care. Accordingly, we aimed to compare the effects of combined MT and SSC and SSC alone on ANS stabilization in preterm infants. In a single-center, cluster-randomized trial design, ten two-month time-clusters were randomized to either combined MT and SSC or SSC alone. Families of preterm infants were offered two sessions of the allocated condition in the NICU, and a three-month follow up session at home. The primary outcome variable was stabilization of the ANS, defined by change in the high frequency (HF) power of heart rate variability (HRV) during the second session. Secondary outcomes included other HRV measures, parent–infant attachment, and parental anxiety at each session. Sixty-eight families were included. MT combined with SSC improved infants’ ANS stability, as indicated by a greater increase in HF power during MT compared to SSC alone (mean difference 5.19 m2/Hz, SE = 1.27, p < 0.001) (95% confidence interval 0.87 to 2.05). Most secondary outcomes were not significantly different between the study groups. MT contributes to preterm-infants’ autonomic stability, thus laying an important foundation for neuro-behavioral and psycho-emotional development. Studies evaluating longer-term effects of MT on preterm infants’ development are warranted.

scholarly journals Does #Tamojunto alter the dynamic between drug use and school violence among youth? Secondary analysis from a large cluster-randomized trial

2021 ◽  
Author(s):  
Hugo Cogo-Moreira ◽  
Julia D. Gusmões ◽  
Juliana Y. Valente ◽  
Michael Eid ◽  
Zila M. Sanchez
Keyword(s):  
Drug Use ◽  
School Violence ◽  
Causal Effect ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cluster Randomized Trial ◽  
Random Intercept ◽  
Carry Over ◽  
Cluster Randomized ◽  
Use Behavior

AbstractThe present study investigated how intervention might alter the relationship between perpetrating violence and later drug use. A cluster-randomized controlled trial design involving 72 schools (38 intervention, 34 control) and 6390 students attending grades 7 and 8 was employed in Brazil. Drug use and violence were assessed at three points. A random-intercept cross-lagged panel model examined the reciprocal association between drug use and school violence domains across the three data collection waves. For both groups, we found that the cross-lagged effect of perpetration on further drug use in adolescents was stronger than the reverse, but the interrelationship was not statistically significant between #Tamojunto and control schools. The carry-over effects of drug use and violence were also not significantly different between groups. There is a lack of evidence showing that #Tamojunto can modify the dynamics between drug use and school violence across the 21-month period. The direction of the causal effect (i.e., the more perpetration behavior, the more subsequent drug use behavior) is present, but weak in both groups. The trial registration protocol at the national Brazilian Register of Clinical Trials (REBEC) is #RBR-4mnv5g.

scholarly journals Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abdou Amza ◽  
Boubacar Kadri ◽  
Beido Nassirou ◽  
Ahmed M. Arzika ◽  
Ariana Austin ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Baseline Assessment ◽  
Randomized Controlled ◽  
Registration Number ◽  
Cluster Randomized ◽  
Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

Prognostic understanding, hospitalization, and hospice use among older patients with advanced cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12037-12037
Author(s):  
Kah Poh Loh ◽  
Christopher Seplaki ◽  
Reza Yousefi Nooraie ◽  
Jennifer Leigh Lund ◽  
Ronald M. Epstein ◽  
...  
Keyword(s):  
Older Adults ◽  
Advanced Cancer ◽  
Generalized Estimating Equations ◽  
Older Patients ◽  
Cluster Randomized Trial ◽  
Response Options ◽  
Lower Odds ◽  
Poor Understanding ◽  
Cluster Randomized ◽  
Hospice Use

12037 Background: Poor prognostic understanding of curability is associated with lower hospice use in patients with advanced cancer. Little is known if this holds true for older adults specifically. In addition, prognostic understanding are variably assessed and defined in prior studies. We evaluated the associations of poor prognostic understanding and patient-oncologist discordance in both curability and survival estimates with hospitalization and hospice use in older patients with advanced cancer. Methods: We utilized data from a national geriatric assessment cluster-randomized trial (URCC 13070: PI Mohile) that recruited 541 patients aged ≥70 with incurable solid tumor or lymphoma considering any line of cancer treatment and their oncologists. At enrollment, patients and oncologists were asked about their beliefs about cancer curability (options: 100%, > 50%, 50/50, < 50%, 0%, and uncertain) and estimates of patient’s survival (options: 0-6 months, 7-12 months, 1-2 years, 2-5 years, and > 5 years). Non-0% options were considered poor understanding of curability (uncertain was removed from the analysis) and > 5 years was considered poor understanding of survival estimates. Any difference in response options was considered discordant. We used generalized estimating equations to estimate adjusted odds ratios (AOR) assessing associations of poor prognostic understanding and discordance with hospitalization and hospice use at 6 months, adjusting for covariates and practice clusters. Results: Poor prognostic understanding of curability and survival estimates occurred in 59% (206/348) and 41% (205/496) of patients, respectively. Approximately 60% (202/336) and 72% (356/492) of patient-oncologist dyads were discordant in curability and survival estimates, respectively. In the first 6 months after enrollment, 24% were hospitalized and 15% utilized hospice. Poor prognostic understanding of survival estimates was associated with lower odds of hospice use (AOR 0.30, 95% CI 0.16-0.59) (Table). Discordance in survival estimates was associated with greater odds of hospitalization (AOR 1.64, 95% CI 1.01-2.66). Conclusions: Prognostic understanding may be associated with hospitalization or hospice use depending on how patients were queried about their prognosis and whether oncologists’ estimates were considered.[Table: see text]

scholarly journals A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lisa Zubkoff ◽  
Kathleen Doyle Lyons ◽  
J. Nicholas Dionne-Odom ◽  
Gregory Hagley ◽  
Maria Pisu ◽  
...  
Keyword(s):  
Palliative Care ◽  
Advanced Cancer ◽  
Technical Assistance ◽  
Controlled Trial ◽  
Implementation Strategies ◽  
Care Program ◽  
Early Palliative Care ◽  
Randomized Controlled ◽  
Community Oncology ◽  
Cluster Randomized

Abstract Background Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration Clinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

scholarly journals Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jaameeta Kurji ◽  
Lakew Abebe Gebretsadik ◽  
Muluemebet Abera Wordofa ◽  
Sudhakar Morankar ◽  
Kunuz Haji Bedru ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Safe Motherhood ◽  
Link Type ◽  
Local Leader ◽  
Maternity Waiting Homes ◽  
Leader Training ◽  
Cluster Randomized

Abstract Background Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration The trial was retrospectively registered on the Clinical Trials website (https://clinicaltrials.gov) on 3rd October 2017. The trial identifier is NCT03299491.

scholarly journals Impact of group-based dietary education on the dietary habits of female adolescents: a cluster randomized trial

2010 ◽  
Vol 14 (4) ◽  
pp. 702-708 ◽  
Author(s):  
Kazue Yamaoka ◽  
Mariko Watanabe ◽  
Eisuke Hida ◽  
Toshiro Tango
Keyword(s):  
Dietary Intake ◽  
Energy Intake ◽  
Young Women ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Female Adolescents ◽  
Control Group ◽  
Dietary Education ◽  
Cluster Randomized

AbstractObjectiveThe number of extremely thin young women has increased and education at school on maintaining an optimal weight has become important. The aim of the present study was to assess the effectiveness of a group-based home-collaborative dietary education (HCDE) programme to maintain appropriate dietary intake compared to conventional school classroom education.DesignTwo-arm cluster randomized controlled trial. Twelve classes were randomly assigned as clusters to either the HCDE group or the control group. Each participant in the HCDE group received twelve sessions of group counselling aimed at increasing energy intake at breakfast by modifying dietary intake and adopting appropriate habits. The hypothesis underlying the study was that after 6 months of HCDE the total energy intake would be increased by 627 kJ from baseline (primary endpoint). Secondary outcomes were differences in intake of various nutrients from baseline. Outcome measures after log transformation were examined by t tests and linear mixed models (crude and baseline-adjusted).SettingYoung women among Japanese female adolescents in Tokyo.SubjectsFour hundred and seventy-four participants aged 13–15 years.ResultsStudents in twelve classes were used for analysis (n 459). Energy intake was decreased in many of the classes during the 6-month period, especially for those in the control group. After adjustment for the baseline value, significant increases in energy intake and protein, calcium, magnesium and iron intakes at breakfast were observed (P < 0·05)ConclusionsAlthough energy intake was increased in the HCDE group compared to the control group, further study of the HCDE is warranted.

Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist

2020 ◽  
Vol 41 (11) ◽  
pp. 1266-1271
Author(s):  
Trevor C. Van Schooneveld ◽  
Mark E. Rupp ◽  
R. Jenifer Cavaleiri ◽  
Elizabeth Lyden ◽  
Kiri Rolek
Keyword(s):  
Controlled Trial ◽  
Early Period ◽  
Cluster Randomized Trial ◽  
Antibiotic Use ◽  
Effective Strategies ◽  
Randomized Controlled ◽  
Time Out ◽  
Academic Medical ◽  
Cluster Randomized ◽  
Medicine Team

AbstractObjective:Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.Design:Cluster randomized controlled trial.Setting:Six medicine teams at an academic medical facility.Patients:Inpatients who received antibiotics and were cared for by a medicine team.Intervention:In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).Results:In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.Conclusions:Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.

scholarly journals Feasibility of Conducting Nonpharmacological Interventions to Manage Dementia Symptoms in Community-Dwelling Older Adults: A Cluster Randomized Controlled Trial

2019 ◽  
Vol 35 ◽  
pp. 153331751987263 ◽  
Author(s):  
Juyoung Park ◽  
Magdalena I. Tolea ◽  
Diane Sherman ◽  
Amie Rosenfeld ◽  
Victoria Arcay ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Retention Rate ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Cluster Randomized Controlled Trial ◽  
Group Differences ◽  
Significant Group ◽  
Randomized Controlled ◽  
Cluster Randomized

This study assessed the feasibility of conducting 3 nonpharmacological interventions with older adults in dementia, exploring the effects of chair yoga (CY), compared to music intervention (MI) and chair-based exercise (CBE) in this population. Using a cluster randomized controlled trial (RCT), 3 community sites were randomly assigned 1:1:1 to CY, MI, or CBE. Participants attended twice-weekly 45-minute sessions for 12 weeks. Thirty-one participants were enrolled; 27 safely completed the interventions and final data collection (retention rate of 87%). Linear mixed modeling was performed to examine baseline and longitudinal group differences. The CY group improved significantly in quality of life compared to the MI group (CY mean = 35.6, standard deviation [SD] = 3.8; MI mean = 29.9, SD = 5.3, P = .010). However, no significant group differences were observed in physical function, behavioral, or psychological symptoms (eg, for mini-PPT: slopetime = 0.01, standard error [SE] = 0.3, P = .984 in the CBE group; slopetime = −0.1, SE = 0.3, P = .869 in the MI group; slopetime = −0.3, SE = 0.3, P = .361 in the CY group) over the 12-week intervention period. Overall, this pilot study is notable as the first cluster RCT of a range of nonpharmacological interventions to examine the feasibility of such interventions in older adults, most with moderate-to-severe dementia. Future clinical trials should be conducted to examine the effects of nonpharmacological interventions for older adults with dementia on health outcomes.

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