Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer With The Psychosocial Assessment Tool (PAT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Ethnic minority families screened
研究概览
简要总结
The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the social ecology, including patient and caregiver physical and psychosocial health. It is the strong recommendation from the first Standard of the Psychosocial Standards of Care in Pediatric Cancer that cancer centers engage in universal, systematic, psychosocial risk screening for newly diagnosed patients and their families. Universal screening at diagnosis fosters early identification of psychosocial risks and provides the opportunity to match psychosocial care to the level of family need for more equitable, effective and integrated services. However, few programs offer such care in an efficient, comprehensive, and consistent manner, potentially resulting in insufficient care that magnifies inequities in outcomes. To support pediatric cancer centers in their goal of meeting the first Standard of Psychosocial Care, this study will compare two implementation strategies for the Psychosocial Assessment Tool (PAT), a validated parent report screener of family psychosocial risk in English and Spanish, in a cluster randomized trial across 18 pediatric cancer programs in the United States.
详细描述
Background: Childhood cancer affects multiple levels of the social ecology, including social determinants of health (e.g. financial and resource issues, child and family problems). The 2015 Standards of Psychosocial Care in Pediatric Cancer outline optimal psychosocial care, starting with a standard devoted to assessment of psychosocial healthcare needs. The Psychosocial Assessment Tool (PAT) is a validated family psychosocial risk screener now ready for broad implementation. Method: The PAT will be implemented across a national sample of 18 pediatric cancer programs in a comparative effectiveness study, guided by the Interactive Systems Framework for Dissemination and Implementation, comparing two Strategies. It is hypothesized that implementation will be more successful at the patient/family, provider, and institutional level when Training (Strategy I) is combined with Implementation Expanded Resources (Strategy II). The trial will be informed by input from Stakeholders and will result in a web-based Toolkit for dissemination nationally. Sites will be randomized to cohort (one of three years) and strategy (Strategy I, II) for the trial. Outcomes include adoption and penetration of screening (patient/family), staff job satisfaction/burnout (provider), and cost effective use of resources consistent with family risk (institution). Discussion Use of the PAT across children's cancer programs nationally can achieve the assessment Standard and deliver psychosocial care matched to family need for all patients, especially those most impacted by health inequities.
Based on the Interactive Systems Framework for Dissemination and Implementation (ISF), this study is a comparative effectiveness trial of the two strategies at 18 childhood cancer centers of three sizes based on new patients per year, examining family (penetration, health equity), provider (feasibility, acceptability, burnout and job satisfaction), and institution (adoption, sustainability, costs) implementation outcomes.7 Sites will be randomized to time of implementation (three cohorts) and Strategy (two - I, II).
Aim. Compare the two theoretically based and empirically informed strategies to implement the PAT in English and Spanish using a cluster randomized controlled trial. Compared to Training:
H1. At the patient/family level, TIER will be associated with: a) a higher proportion of families of newly diagnosed children screened and provided with feedback (penetration); and b) higher rates of screening for ethnic minority and socioeconomically diverse families (health equity).
H2. At the provider level, TIER will be: a) more feasible and rated as appropriate and acceptable; b) associated with greater engagement in addressing health disparities; and c) associated with less burnout and better job satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
This is an implementation trial in which institutions are assigned to conditions. There is no masking.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sites were selected in advance based on data collected in a previous study regarding psychosocial staffing in the pediatric cancer program.
- •Sites that were at or above the median for size of their psychosocial staff were eligible. - --
- •Site selection took into consideration number of new pediatric cancer patients annually, geographical representation and sites with significant proportions of Spanish speaking families and/or families of low socioeconomic status.
排除标准
- •- Sites with psychosocial staffing below the median in the prior study were not eligible.
结局指标
主要结局
Ethnic minority families screened
时间窗: At conclusion of cohort year (12 months post baseline)
Number of ethnic minority families screened divided by number of ethnic minority families eligible
Intervention Appropriateness Measure (IAM)
时间窗: Baseline, 6 months, 12 months
Changes in perceived appropriateness of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher appropriateness
Families screened
时间窗: At conclusion of cohort year (12 months post baseline)
Number of families screened divided by number of families eligible
Families provided feedback
时间窗: At conclusion of cohort year (12 months post baseline)
Number of families provided feedback divided by number of families screened
Physician Engagement in Addressing Racial and Ethnic Health Care Disparities (AREA) scale
时间窗: Baseline, 6 and 12 months
Changes in level of engagement in addressing health disparities as measured by the AREA, a 9 point scale with a 5 point likert response. Total scores range from 0 to 36 with higher scores indicating higher level of engagement
Feasibility of Intervention Measure (FIM)
时间窗: Baseline, 6 months, 12 months
Changes in perceptions of the feasibility of using the PAT measured with this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher feasibility
Site Participation Rate
时间窗: At conclusion of the study (12 months post baseline)
Number of sites that completed the study divided by sites enrolled
Maslach Burnout Inventory (MBI)
时间窗: Baseline, 6 and 12 months
Changes in burnout measured with this 22 item scale with a items on a 7 point Likert scale, higher scores indicate higher job satisfaction. Range of scores is from 0 to 42.
Acceptability of Intervention Measure (AIM)
时间窗: Baseline, 6 months, 12 months
Changes in acceptability of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher acceptability
次要结局
未报告次要终点
研究者
Anne E Kazak, PhD, ABPP
Center Director
Nemours Children's Clinic