Decision aids for localized prostate cancer: Initial outcomes from NCI Community Oncology Research Program Alliance Research Base Cancer Care Delivery Research (CCDR) Protocol - A191402CD - A Cluster-Randomized Trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24176-e24176
Author(s):  
Jon Charles Tilburt ◽  
Joel E Pacyna ◽  
Daniel G. Petereit ◽  
Judith Salmon Kaur ◽  
Bruce D. Rapkin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Usual Care ◽  
Care Delivery ◽  
Decision Aids ◽  
Clinical Stage ◽  
Cluster Randomized Trial ◽  
Relative Effect ◽  
Oncology Research ◽  
Cluster Randomized ◽  
Cluster Correlation

e24176 Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .

Lessons learned from implementing the first Alliance NCORP Research Base Cancer Care Delivery Research (CCDR) trial A191402CD.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 175-175
Author(s):  
Joel E Pacyna ◽  
Jeff A. Sloan ◽  
Simon P. Kim ◽  
Hillary Sedlacek ◽  
Jon Charles Tilburt
Keyword(s):  
Clinical Trials ◽  
Cancer Care ◽  
Early Stage ◽  
Care Delivery ◽  
Decision Aids ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Lessons Learned ◽  
Oncology Research ◽  
Minority Men

175 Background: Biomedical research focused on the experiences of cancer patients in care delivery has progressed remarkably in recent years, including the emergence of Cancer Care Delivery Research (CCDR) within the NCI Community Oncology Research Program (NCORP). CCDR is a relatively new mechanism with the NCORP to support protocols that test questions beyond standard clinical trials for treatment or symptom control interventions. CCDR leverages the NCORP infrastructure to develop and test care delivery interventions in community hospital settings and in settings serving underserved and minority populations. CCDR enables researchers to conduct care delivery studies in critical places and in niche populations. Methods: We will describe our experience coordinating the first Alliance NCORP Research Base Cancer CCDR trial. Our trial – a four arm, cluster-randomized trial of decision aids among sites capable of oversampling minority men with a diagnosis of early stage prostate cancer – was the first CCDR trial in the Alliance NCORP Research Base. We will describe the opportunities and challenges we encountered. Results: We implemented a CCDR protocol even as the oversight for CCDR was being worked out in parallel. Curating partnerships outside of established channels of clinical trials, engaging minority serving institutions, and engaging surgical practices like urology illustrate some of the challenges of implementing a care-delivery trial in a diverse multi-site network. Research staff must learn the art of mitigating the disruption of care delivery research procedures within clinics. Additionally, the researcher’s skills are drawn upon at multiple points— establishing relationships, advocating for flexibility in implementing rules, cheerleading, connecting dots, and directing traffic. Conclusions: Our “lessons learned” presentation will provide an experiential account that will inform aspiring care delivery researchers in their work and describe some of the emerging aspects of the institutional implementation of new initiatives in modern cooperative group research. Our presentation will also inform key stakeholders about how to best facilitate this type of research.

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 The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration

2019 ◽  
Vol 30 (5) ◽  
pp. 890-903 ◽  
Author(s):  
Laura M. Dember ◽  
Eduardo Lacson ◽  
Steven M. Brunelli ◽  
Jesse Y. Hsu ◽  
Alfred K. Cheung ◽  
...  
Keyword(s):  
Usual Care ◽  
Care Delivery ◽  
Clinical Care ◽  
Pragmatic Trial ◽  
Intervention Group ◽  
Time Trial ◽  
Hospitalization Rate ◽  
Maintenance Hemodialysis ◽  
Session Duration ◽  
Cluster Randomized

BackgroundData from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.MethodsTo develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.ResultsThe trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care.ConclusionsAlthough a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

Improving communication with older patients with cancer using geriatric assessment (GA): A University of Rochester NCI Community Oncology Research Program (NCORP) cluster randomized controlled trial (CRCT).

2018 ◽  
Vol 36 (18_suppl) ◽  
pp. LBA10003-LBA10003 ◽  
Author(s):  
Supriya Gupta Mohile ◽  
Ronald M. Epstein ◽  
Arti Hurria ◽  
Charles E. Heckler ◽  
Paul Duberstein ◽  
...  
Keyword(s):  
Usual Care ◽  
Older Patients ◽  
Controlled Trial ◽  
Intraclass Correlation ◽  
Clinic Visit ◽  
Adverse Outcomes ◽  
Oncology Research ◽  
Age Related ◽  
Cluster Randomized

LBA10003 Background: GA includes validated measures that assess age-related health domains (e.g., function, cognition) known to increase adverse outcomes. In this PCORI and NCI funded CRCT, we evaluated if providing a GA summary and recommendations for GA-guided interventions improves communication about age-related concerns for older patients (pts) with cancer. Methods: Pts aged ≥ 70 with advanced solid tumors or lymphoma and at least 1 impaired GA domain were enrolled. Oncology practices were randomized to intervention (oncologists received GA summary) or usual care (no summary provided). The primary outcomes were: 1) number of discussions about age-related concerns (the clinic visit after GA was audio-recorded and transcribed; 2 blinded coders evaluated quality of communication and plan for follow-up interventions) and 2) telephone surveys of patient satisfaction (modified Health Care Climate Questionnaire [HCCQ-age] scored 7-35). Outcomes were analyzed using linear mixed models with arm as the fixed effect, controlling for practice. Results: From 2014-17, 544 pts (295 in GA) were enrolled from 31 practices. There were no differences in demographics by arm (mean age 77 yrs; 49% female). More patients in usual care had impaired physical performance (96% vs 92%, p = 0.03) and social support (33% vs 25%, p = 0.05). In 530 evaluable pts, the overall mean number of discussions was 6.3 (SD: 4.0). The GA arm had 3.5 more discussions about age-related concerns (95%CI: 2.28-4.72, p = 10-6; intraclass correlation coefficient [ICC] = 0.24) compared to usual care; of these, in the GA arm, 2.0 more discussions on average had higher quality communication (95%CI: 1.20-2.69; p = 6x10-6) and 1.9 more led to interventions (95% CI: 1.14-2.73; p = 1.6x10-5). The GA arm had significantly more discussions for almost all GA domains. In 511 pts with HCCQ-age, the mean score was 22.9 (SD 4.5); the score was 1.12 points higher in the GA arm (95%CI: 0.23-2.03; p = .027; ICC = 0.02). Conclusions: Providing a GA summary to oncologists increases the number and quality of discussions about age-related concerns and improves pt satisfaction. Clinical trial information: NCT02107443.

scholarly journals Patients’ experience of communication and handling of symptomatic adverse events in breast cancer patients receiving adjuvant chemotherapy

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Christina Witt Bæksted ◽  
Aase Nissen ◽  
Ann S. Knoop ◽  
Helle Pappot
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Usual Care ◽  
Cancer Patients ◽  
Cluster Randomized Trial ◽  
Breast Cancer Patients ◽  
High Satisfaction ◽  
Patient Reported ◽  
Patient Representatives ◽  
Cluster Randomized

Abstract Background The study is based on a national cluster randomized trial investigating the effect of electronic patient-reported outcomes (ePRO) on treatment outcomes in breast cancer patients receiving adjuvant chemotherapy. All 13 oncology departments (11 clusters) treating breast cancer patients in Denmark were randomized to use electronic patient-reported outcomes with real-time clinician feedback (ePRO arm) to track symptoms or usual care for eliciting symptoms using a short paper tracking list (usual care arm). The impact of ePRO on clinical outcomes were examined, which is reported elsewhere. The purpose of the present study was to examine patient-reported experience measure (PREM) regarding communication and handling of side effects/symptoms. Methods For this sub-study, patient representatives were involved in the development of a PREM questionnaire. Patients enrolled in the cluster randomized trial completed the PREM questionnaire at their last treatment visit. Semi-structured telephone-interviews were performed with a subgroup of patients. The interviews were based on an interview guide comprised of the questions from the PREM questionnaire and aimed to elaborate on the PREM questionnaire data. Results A 12 item PREM questionnaire was developed in partnership with patient representatives. In total, 439 out of 682 patients (64.4%) included patients completed the PREM questionnaire. Telephone semi-structured interviews were performed with 22 patients. In total, 52% (ePRO arm) and 65% (usual care arm) reported having talked with the oncologist/nurse about their responses in the tracking systems before each chemotherapy cycle. Fewer patients in the ePRO arm compared to the usual care arm experienced side effects/symptoms not included in the side effect questionnaire. Patients experienced high satisfaction with oncologists’ and nurses’ handling of side effects/symptoms. Conclusions Patients experienced high satisfaction with oncologists’ and nurses’ handling of chemotherapy adverse events. The study indicates a need for a more comprehensive side effect questionnaire as tracking system covering more symptoms than the one used in usual care today. Trial registration Clinicaltrials.gov identifier NCT02996201. Registered 19 December 2016, retrospectively registered.

scholarly journals Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand

BMJ ◽  
2020 ◽  
pp. m3797 ◽  
Author(s):  
Justin S White ◽  
Christopher Lowenstein ◽  
Nucharee Srivirojana ◽  
Aree Jampaklay ◽  
William H Dow
Keyword(s):  
Usual Care ◽  
Text Messaging ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Monetary Incentive ◽  
Care Group ◽  
Smoking Abstinence ◽  
Open Label ◽  
Intention To Treat ◽  
Cluster Randomized

Abstract Objective To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country. Design Parallel group, open label, assessor blinded, cluster randomized controlled trial. Setting Large industrial workplaces in metropolitan Bangkok, Thailand. Participants Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies). Interventions Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40). Main outcome measures The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers. Results Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval −2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; −3.2 points, −6.6 to −0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other. Conclusions Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings. Trial registration ClinicalTrials.gov ( NCT02421224 ).

scholarly journals Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention

Endocrine ◽  
2021 ◽  
Author(s):  
Marleen Kunneman ◽  
Megan E. Branda ◽  
Jennifer L. Ridgeway ◽  
Kristina Tiedje ◽  
Carl R. May ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Decision Making ◽  
Mixed Methods ◽  
Medication Adherence ◽  
Usual Care ◽  
Cluster Randomized Trial ◽  
Patient Knowledge ◽  
Cluster Randomized

Abstract Purpose To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. Methods In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. Results We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. Conclusions Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. Clinical trial registration ClinicalTrial.gov: NCT01502891.

The impact of within-visit and pre-visit decision aids for localized prostate cancer on patient knowledge.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 151-151
Author(s):  
Jon Charles Tilburt ◽  
Joel E Pacyna ◽  
Kristin Cina ◽  
Daniel G. Petereit ◽  
Judith Salmon Kaur ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Linear Regression ◽  
Cancer Treatment ◽  
Usual Care ◽  
Decision Aid ◽  
Decision Aids ◽  
Specific Antigen ◽  
Patient Knowledge ◽  
Prostate Cancer Treatment ◽  
The Impact

151 Background: Decision aids (DAs) for prostate cancer treatment can improve knowledge and reduce decisional conflict, but the relative effect of pre-visit and within-visit DAs is not known, and effect sizes for minority populations has not been estimated. Methods: We conducted a 3-arm, patient-level-RCT in specialty urology and radiation oncology practices in Ohio, South Dakota, and Alaska, test the effect of pre-consultation and with-in consultation decision aids on patient knowledge immediately after specialty consultation compared to usual care. We used linear regression to estimate effects of each intervention arm, including the respective standard error, two-sided 95% confidence interval, and two-sided P value for testing the study’s hypotheses. Results: 103 patients were recruited and randomized to receive either the pre-visit decision aid, within-visit decision aid, or neither decision aids (usual care). In 2017 and 20018, we accrued similar numbers of men to pre-consultation aid (n = 37), during-consultation aid (n = 33) and usual care arms, respectively (n = 33). The median (range) age in years was 64 [49, 81]; 67.6% were White, 15.7% were Black or African American, 16.7% were American Indian or Alaska Native, and 1% were not reported. 47.6%, 45.6%, and 6.8% had a baseline clinical stage of T1, T2, and T3, respectively. The median [range] prostate specific antigen (PSA) was 8.0 [2.4, 53.7]. There were no clinically notable imbalances. We obtained usable data on 102 of the 103 patient-participants. The pre-visit decision aid arm showed a mean knowledge effect of 0.694 (0.636, 0.753). The within-visit decision arm showed a very similar mean knowledge effect of 0.686 (0.625, 0.748). The usual care arm showed a mean knowledge effect of 0.644 (0.582,0.705). The linear regression model showed, that, compared with usual care, neither intervention effect achieved statistical significance in the primary analysis (p = 0.24, 0.330, for pre-visit and within-visit, respectively). Conclusions: Modest knowledge gains of pre-visit and during-visit decision aids for prostate cancer treatment were not statistically significant. Clinical trial information: NCT03182998 .

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