Symptom management care pathway adaptation process and specific adaptation decisions

BACKGROUND: There is substantial heterogeneity in symptom management provided to pediatric patients with cancer. The primary objective was to describe the adaptation process and specific adaptation decisions related to symptom management care pathways based on clinical practice guidelines. The secondary objective evaluated if institutional factors were associated with adaptation decisions. METHODS: Fourteen previously developed symptom management care pathway templates were reviewed by an institutional adaptation team composed of two clinicians at each of 10 institutions. They worked through each statement for all care pathway templates sequentially. The institutional adaptation team made the decision to adopt, adapt or reject each statement, resulting in institution-specific symptom management care pathway drafts. Institutional adaption teams distributed the 14 care pathway drafts to their respective teams; their feedback led to care pathway modifications. RESULTS: Initial care pathway adaptation decision making was completed over a median of 4.2 (interquartile range 2.0-5.3) weeks per institution. Across all institutions and among 1350 statements, 551 (40.8%) were adopted, 657 (48.7%) were adapted, 86 (6.4%) were rejected and 56 (4.1%) were no longer applicable because of a previous decision. Most commonly, the reason for rejection was not agreeing with the statement (70/86, 81.4%). Institutional-level factors were not significantly associated with statement rejection. CONCLUSIONS: Acceptability of the 14 care pathways was evident by most statements being adopted or adapted. The adaptation process was accomplished over a relatively short timeframe. Future work should focus on evaluation of care pathway compliance and determination of the impact of care pathway-consistent care on patient outcomes. TRIAL REGISTRATION: clinicaltrials.gov, NCT04614662. Registered 04/11/2020, https://clinicaltrials.gov/ct2/show/NCT04614662?term=NCT04614662&draw=2&rank=1

Enhancing the Evidence for Behavioral Counseling A Perspective From the Society of Behavioral Medicine

U.S. Preventive Services Task Force (USPSTF) clinical guidelines at present rarely assign the highest grade recommendation to behavioral counseling interventions for chronic disease prevention or risk reduction because of concerns about the certainty and quality of the evidence base. As a result, the broad integration of behavioral counseling interventions in primary care remains elusive. Thus, there is an urgent need for novel perspectives on how to generate the highest-quality and -certainty evidence for primary care–focused behavioral counseling interventions. As members of the Society of Behavioral Medicine (SBM)—a multidisciplinary scientific organization committed to improving population health through behavior change—we review the USPSTF mandate and current recommendations for behavioral counseling interventions and provide a perspective for the future that calls for concerted and coordinated efforts among SBM, USPSTF, and other organizations invested in the rapid and wider uptake of beneficial, feasible, and referable primary care–focused behavioral counseling interventions. This perspective highlights five areas for further development, including (1) behavioral counseling–focused practice-based research networks; (2) promotion of USPSTF evidence standards and the increased use of pragmatic RCT design; (3) quality control and improvement procedures for behavioral counseling training; (4) systematic research on effective primary care–based collaborative care models; and (5) methodologic innovations that capitalize on disruptive technologies and healthcare transformation. Collective efforts to improve the health of all Americans in the 21st century and beyond must ensure that effective, feasible, and referable behavioral counseling interventions are embedded in modern primary care practice

Barriers to symptom management care pathway implementation in pediatric cancer

BACKGROUND: Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. METHODS: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. RESULTS: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). CONCLUSIONS: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology

Understanding disruptions in cancer care to reduce increased cancer burden

BACKGROUND: This study seeks to understand how and for whom COVID-19 disrupted cancer care to understand the potential for cancer health disparities across the cancer prevention and control continuum. METHODS: In this cross-sectional study, participants age 30+residing in an 82-county region in Missouri and Illinois completed an online survey from June-August 2020. Descriptive statistics were calculated for all variables separately and by care disruption status. Logistic regression modeling was conducted to determine the correlates of care disruption. RESULTS: Participants (N=680) reported 21% to 57% of cancer screening or treatment appointments were canceled/postponed from March 2020 through the end of 2020. Approximately 34% of residents stated they would need to know if their doctor\u27s office is taking the appropriate COVID-related safety precautions to return to care. Higher education (OR = 1.26, 95% CI:1.11-1.43), identifying as female (OR = 1.60, 95% CI:1.12-2.30), experiencing more discrimination in healthcare settings (OR = 1.40, 95% CI:1.13-1.72), and having scheduled a telehealth appointment (OR = 1.51, 95% CI:1.07-2.15) were associated with higher odds of care disruption. Factors associated with care disruption were not consistent across races. Higher odds of care disruption for White residents were associated with higher education, female identity, older age, and having scheduled a telehealth appointment, while higher odds of care disruption for Black residents were associated only with higher education. CONCLUSIONS: This study provides an understanding of the factors associated with cancer care disruption and what patients need to return to care. Results may inform outreach and engagement strategies to reduce delayed cancer screenings and encourage returning to cancer care. FUNDING: This study was supported by the National Cancer Institute\u27s Administrative Supplements for P30 Cancer Center Support Grants (P30CA091842-18S2 and P30CA091842-19S4). Kia L. Davis, Lisa Klesges, Sarah Humble, and Bettina Drake were supported by the National Cancer Institute\u27s P50CA244431 and Kia L. Davis was also supported by the Breast Cancer Research Foundation. Callie Walsh-Bailey was supported by NIMHD T37 MD014218. The content does not necessarily represent the official view of these funding agencies and is solely the responsibility of the authors

Self-sampling tools to increase cancer screening among underserved patients: A pilot randomized controlled trial

BACKGROUND: Screening can reduce cancer mortality, but uptake is suboptimal and characterized by disparities. Home-based self-sampling can facilitate screening for colorectal cancer (with stool tests, eg, fecal immunochemical tests) and for cervical cancer (with self-collected human papillomavirus tests), especially among patients who face barriers to accessing health care. Additional data are needed on feasibility and potential effects of self-sampling tools for cancer screening among underserved patients. METHODS: We conducted a pilot randomized controlled trial with patients (female, ages 50-65 years, out of date with colorectal and cervical cancer screening) recruited from federally qualified health centers in rural and racially segregated counties in Pennsylvania. Participants in the standard-of-care arm (n = 24) received screening reminder letters. Participants in the self-sampling arm (n = 24) received self-sampling tools for fecal immunochemical tests and human papillomavirus testing. We assessed uptake of screening (10-week follow-up), self-sampling screening outcomes, and psychosocial variables. Analyses used Fisher exact tests to assess the effect of study arm on outcomes. RESULTS: Cancer screening was higher in the self-sampling arm than the standard-of-care arm (colorectal: 75% vs 13%, respectively, odds ratio = 31.32, 95% confidence interval = 5.20 to 289.33; cervical: 79% vs 8%, odds ratio = 72.03, 95% confidence interval = 9.15 to 1141.41). Among participants who returned the self-sampling tools, the prevalence of abnormal findings was 24% for colorectal and 18% for cervical cancer screening. Cancer screening knowledge was positively associated with uptake (P \u3c .05). CONCLUSIONS: Self-sampling tools can increase colorectal and cervical cancer screening among unscreened, underserved patients. Increasing the use of self-sampling tools can improve primary care and cancer detection among underserved patients. CLINICAL TRIALS REGISTRATION NUMBER: STUDY00015480

Impact of the COVID-19 pandemic on the implementation of mobile health to improve the uptake of hydroxyurea in patients with sickle cell disease: Mixed methods study

BACKGROUND: Hydroxyurea therapy is effective for reducing complications related to sickle cell disease (SCD) and is recommended by National Health Lung and Blood Institute care guidelines. However, hydroxyurea is underutilized, and adherence is suboptimal. We wanted to test a multilevel mobile health (mHealth) intervention to increase hydroxyurea adherence among patients and improve prescribing among providers in a multicenter clinical trial. In the first 2 study sites, participants were exposed to the early phases of the COVID-19 pandemic, which included disruption to their regular SCD care. OBJECTIVE: We aimed to describe the impact of the COVID-19 pandemic on the implementation of an mHealth behavioral intervention for improving hydroxyurea adherence among patients with SCD. METHODS: The first 2 sites initiated enrollment 3 months prior to the start of the pandemic (November 2019 to March 2020). During implementation, site A clinics shut down for 2 months and site B clinics shut down for 9 months. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to evaluate the implementation and effectiveness of the intervention. mHealth implementation was assessed based on patients\u27 daily app use. Adherence to hydroxyurea was calculated as the proportion of days covered (PDC) from prescription records over the first 12 and 24 weeks after implementation. A linear model examined the relationship between app usage and PDC change, adjusting for baseline PDC, lockdown duration, and site. We conducted semistructured interviews with patients, health care providers, administrators, and research staff to identify factors associated with mHealth implementation and effectiveness. We used a mixed methods approach to investigate the convergence of qualitative and quantitative findings. RESULTS: The percentage of patients accessing the app decreased after March 15, 2020 from 86% (n=55) to 70% (n=45). The overall mean PDC increase from baseline to week 12 was 4.5% (P=.32) and to week 24 was 1.5% (P=.70). The mean PDC change was greater at site A (12 weeks: 20.9%; P=.003; 24 weeks: 16.7%; P=.01) than site B (12 weeks: -8.2%; P=.14; 24 weeks: -10.3%; P=.02). After adjustment, PDC change was 13.8% greater in those with increased app use after March 15, 2020. Interview findings indicated that site B\u27s closure during COVID-19 had a greater impact, but almost all patients reported that the InCharge Health app helped support more consistent medication use. CONCLUSIONS: We found significant impacts of the early clinic lockdowns, which reduced implementation of the mHealth intervention and led to reduced patient adherence to hydroxyurea. However, disruptions were lower among participants who experienced shorter clinic lockdowns and were associated with higher hydroxyurea adherence. Investigation of added strategies to mitigate the effects of care interruptions during major emergencies (eg, patient coaching and health navigation) may insulate the implementation of interventions to increase medication adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16319

Creating research-ready partnerships: The initial development of seven implementation laboratories to advance cancer control

BACKGROUND: In 2019-2020, with National Cancer Institute funding, seven implementation laboratory (I-Lab) partnerships between scientists and stakeholders in \u27real-world\u27 settings working to implement evidence-based interventions were developed within the Implementation Science Centers in Cancer Control (ISC3) consortium. This paper describes and compares approaches to the initial development of seven I-Labs in order to gain an understanding of the development of research partnerships representing various implementation science designs. METHODS: In April-June 2021, members of the ISC3 Implementation Laboratories workgroup interviewed research teams involved in I-Lab development in each center. This cross-sectional study used semi-structured interviews and case-study-based methods to collect and analyze data about I-Lab designs and activities. Interview notes were analyzed to identify a set of comparable domains across sites. These domains served as the framework for seven case descriptions summarizing design decisions and partnership elements across sites. RESULTS: Domains identified from interviews as comparable across sites included engagement of community and clinical I-Lab members in research activities, data sources, engagement methods, dissemination strategies, and health equity. The I-Labs use a variety of research partnership designs to support engagement including participatory research, community-engaged research, and learning health systems of embedded research. Regarding data, I-Labs in which members use common electronic health records (EHRs) leverage these both as a data source and a digital implementation strategy. I-Labs without a shared EHR among partners also leverage other sources for research or surveillance, most commonly qualitative data, surveys, and public health data systems. All seven I-Labs use advisory boards or partnership meetings to engage with members; six use stakeholder interviews and regular communications. Most (70%) tools or methods used to engage I-Lab members such as advisory groups, coalitions, or regular communications, were pre-existing. Think tanks, which two I-Labs developed, represented novel engagement approaches. To disseminate research results, all centers developed web-based products, and most (n = 6) use publications, learning collaboratives, and community forums. Important variations emerged in approaches to health equity, ranging from partnering with members serving historically marginalized populations to the development of novel methods. CONCLUSIONS: The development of the ISC3 implementation laboratories, which represented a variety of research partnership designs, offers the opportunity to advance understanding of how researchers developed and built partnerships to effectively engage stakeholders throughout the cancer control research lifecycle. In future years, we will be able to share lessons learned for the development and sustainment of implementation laboratories

A Multilevel Mhealth intervention Boosts adherence to Hydroxyurea in individuals With Sickle Cell Disease

Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P \u3c 0.001) and sustained (39.7% to 51.4%, P \u3c 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P \u3c 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167

The impact of disseminating the whole-community project '10,000 Steps': a RE-AIM analysis

<p>Abstract</p> <p>Background</p> <p>There are insufficient research reports on the wide-scale dissemination of effective whole-community physical activity (PA) programs. The purpose of this paper is to evaluate the impact of the wide-scale dissemination of '10,000 Steps', using the RE-AIM framework.</p> <p>Methods</p> <p>Dissemination efforts targeted a large region of Belgium and were concentrated on media strategies and peer networks of specific professional organizations, such as local health promotion services. Heads of department of 69 organizations received an on-line survey to assess project awareness, adoption, implementation and intended continuation of '10,000 Steps'. On the individual level, 755 citizens living in the work area of the organizations were interviewed for project awareness and PA levels. Measures were structured according to the RE-AIM dimensions (reach, effectiveness, adoption, implementation, maintenance). Independent sample <it>t </it>and chi-square tests were used to compare groups for representativeness at the organizational and individual level, and for individual PA differences.</p> <p>Results</p> <p>Of all organizations, 90% was aware of '10,000 Steps' (effectiveness - organizational level) and 36% adopted the project (adoption). The global implementation score was 52%. One third intended to continue the project in the future (maintenance) and 48% was still undecided. On the individual level, 35% of citizens were aware of '10,000 Steps' (reach). They reported significantly higher leisure-time PA levels than those not aware of '10,000 Steps' (256 ± 237 and 207 ± 216 min/week, respectively; <it>t </it>= -2.8; p < .005) (effectiveness - individual level). When considering representativeness, adoption of '10.000 Steps' was independent of most organizational characteristics, except for years of experience in PA promotion (7.6 ± 4.6 and 2.9 ± 5.9 years for project staff and non-project staff members, respectively; <it>t </it>= 2.79; <it>p </it>< 0.01). Project awareness in citizens was independent of all demographic characteristics.</p> <p>Conclusions</p> <p>'10,000 Steps' shows potential for wide-scale dissemination but a supportive linkage system seems recommended to encourage adoption levels and high quality implementation.</p