PRECIS-2 Can Assess Pragmatic Aspects of Ongoing Cervical Cancer Screening Trials to Generate Implementation Evidence

Posted on July 30, 2020August 4, 2020 by coprhcon

METHODS

ESTAMPA is a multi-centric screening and triage study recruiting 50,000 women aged 30-64 years, in 12 sites from 9 Latin American countries.[1] The goal of the study is to evaluate different triage methods for HPV positive women and the feasibility of country/setting-specific implementation process. Using the Pragmatic Explanatory Continuum Indicator (PRECIS-2) [2] we conducted a facilitated group discussion with the primary coordinating team from the International Agency for Research on Cancer (IARC) and separately with the country specific study teams. In addition, we surveyed study teams (n=107) using previously validated measures [3] to assess acceptability, appropriateness, and feasibility of conducting the screening process in their context.

RESULTS

Overall, the PRECIS-2 tool allowed for a formal approach to assess pragmatic aspects ESTAMPA from the perspectives of the coordinating team that discussed the study with respect to the nine domains (scores in parenthesis) (Eligibility (5); Recruitment (3); Setting (5); Organization (3); Flexibility of delivery (4); Flexibility of intervention (2); Follow-up (4); Primary outcome (4); and Primary analysis (5). We are currently engaging with the country teams to generate a discussion using PRECIS-2 about the implementation of the trials in their settings. Results from the survey conducted on staff teams show overall acceptability at 63%, appropriateness at 80%, and feasibility at 71%.

CONCLUSIONS

Although ESTAMPA was not designed as a pragmatic trial, we found that it lies mostly in the pragmatic end of the continuum. The trial was conducted with “future implementation in mind” and followed the IARC model of conducting studies where participating countries were considered as partners in research and the study was implemented keeping in mind existing system characteristics. Using PRECIS-2 can help facilitate discussion surrounding the implementation of interventions and processes. This research can helps contextualize research findings and provide decision making guidance for future implementation of effective HPV cervical cancer screening programs in LMICs.

From Clinic to Community: Adapting Evidenced-Based Weight Management for Overweight Latino Children in Immigrant Families

Posted on July 30, 2020August 4, 2020 by coprhcon

BACKGROUND

US born Latino children with immigrant parents, who comprise half of Latino children, have a higher rate of childhood obesity than other Latino children. The US Preventive Services Task Force recommends referral of all obese children to intensive weight management programs to decrease body mass index. When available, intensive programs are limited to clinical settings and do not address social determinants of health among Latino immigrant families. Active and Healthy Families (AHF), a Spanish-language, culturally tailored group visit program for children has demonstrated effectiveness in decreasing body mass index.1 AHF does not address families’ barriers to frequent engagement with the healthcare system nor social determinants barriers other than immigration. Adapting the intervention for community-based delivery may increase acceptability and family engagement.

METHODS

Guided by the intervention mapping-adapt process, we solicited feedback from a stakeholder network from Aug 2018-Dec 2019.2 The network included 4 subcommittees: 1) Latino immigrant families including those who had participated in AHF delivered in a healthcare setting; 2) members of and leaders of community organizations; 3) healthcare services delivery leaders; and 4) researchers in health disparities and Latino health. Subcommittee activities included applying user-centered design principles and Photovoice, a participatory action research method.

RESULTS

Stakeholders identified three functions3 (i.e. essential components) of the evidence-based intervention: a collaborative, multidisciplinary facilitation model, use of the transtheoretical model of change to prompt family-level behavior change tailored to cultural values, and a financially sustainable reimbursement model. The network reached consensus on forms (strategies to meet each function) needed for community-based implementation. Form changes included: 1) different professional roles of facilitators to better align with availability of community experts, family preferences, and to contain costs; 2) incorporation of social determinants facilitators and barriers to behavior change and strategies to mitigate these barriers into the curriculum; and 3) addressing financial sustainability using the Medicare Diabetes Prevention Program as a model. (See Table 1)

High-Intensity Rehabilitation plus Mobility

Posted on July 23, 2020July 29, 2020 by coprhcon

BACKGROUND

Following a hospitalization and skilled nursing facility (SNF) stay, patients are often unprepared for the transition to home, as evidenced by enduring deficits in physical function and continued dependence for activities of daily living (ADLs) at time of discharge. 1) Our previous research has shown that just days before discharge, patients in SNFs took only 916 steps per day and were sitting or lying down 87% of their waking hours. 2) To put this finding into context: participants took far fewer than the ~2,500 steps per day considered basal activity (i.e., the minimum requirement to perform activities of daily living) were ~85% more sedentary than community-dwelling older adults. 3) To combat this pressing problem, we designed High-Intensity Rehabilitation plus Mobility (HeRo), a pilot pragmatic intervention to improve mobility and physical function while in the SNF.

METHODS

A mobility coach with certified nursing assistant credentials will deliver a structured mobility program to complement the progressive rehabilitation intervention that has been successfully implemented at the SNF facility. We will use a pragmatic, pre/post-test design to compare 2 historical cohorts (usual care, progressive rehabilitation alone) to HeRo (progressive rehabilitation coupled with structured mobility). Implementation will be iteratively developed and refined in collaboration with patients and SNF staff to increase adoption and utilization of the intervention. Qualitative interviews with patients and focus groups with providers will complement quantitative measures of effectiveness and implementation in a convergent, embedded mixed-methods design. Program implementation will be evaluated using the Consolidated Framework for Implementation Research4 and the RE-AIM Framework.5 Percent of patients admitted to the SNF who receive the intervention will determine reach. Effectiveness will be measured based on patient-centered outcomes including changes in gait speed, physical function, and physical activity. Focus groups, conducted at regular intervals with rehabilitation and nursing staff throughout the project, will explore how HeRo is integrated into daily practice as key indicators of adoption and potential for maintenance/sustainability. Direct observations of treatment fidelity sessions, documentation audits, and step count goal adherence will serve as indicators of implementation.