Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04446728 |
| Other study ID # |
AK001 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Nemours Children's Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
H3. At the institution level, TIER will be associated with: a) a higher rate of site
participation (adoption), b) more positive perceptions of implementation benefits and fewer
challenges (sustainability); and c) psychosocial care better matched to need demonstrating a
more equitable distribution of services and costs of care.
All sites, regardless of randomization to Strategy I or II, will participate in a 3-hour
professionally prepared internet based learning session (webinar) at the beginning of their
cohort. Each site PI, all staff who will be directly involved in screening, and the research
coordinator will participate. For sites randomized to Strategy II, the Champion will also
attend. The investigators will work with sites to identify the team that will participate in
screening and the Champion (in TIER) ("individuals who dedicate themselves to supporting,
marketing, and driving through an implementation, overcoming indifference or resistance that
the intervention may encounter in an organization"), recognizing that these determinations
will vary across programs. The webinar will be professionally prepared to be engaging and
effective as an educational approach with resource materials provided (Develop Educational
Materials, Distribute Educational Materials).
The training webinar will include all information necessary to access the web-based PAT.
Sites will be provided with a User Agreement, user manual, and access to the password
protected site. The completed PAT is scored immediately and a summary of the score and
clinical concerns identified is sent. Only de-identified data will be transmitted to the
study data core. Sites will be supported in the technical aspects of the implementation
related to using the web-based forms (Centralize Technical Assistance). If any pattern of
problems with technical aspects of implementation is identified, the study staff will
communicate with sites promptly. During training, each site PI and staff involved in
screening will develop a specific implementation plan, describing who will implement the PAT,
who will be screened, where results will be stored, how results will be communicated and how
results will be used (Develop a Formal Implementation Blueprint). For TIER, the Plan includes
questions about the Champion and the Consultation Calls.
Strategy I. For sites randomized to Strategy I (Training), the webinar is the implementation
condition. Sites will also receive technology support, as needed, throughout the one-year
implementation period. These strategies correspond to implementation strategies: creating a
structure for implementation including creating implementation teams, developing an
implementation plan.2
Strategy II. Strategy II, Training + Implementation Expanded Resources (TIER), includes the
same webinar and technical support as in Strategy I with the addition of two evidence-based
resources that may improve implementation (as finalized from analysis of Aim 1 interviews).
The Site PI and center staff conducting screening will participate in a monthly one-hour PAT
Implementation Consultation Call (Provide Ongoing Consultation, Create a Learning
Collaborative). The group format of this strategy is intended to foster group problem-solving
about common issues in implementation and provide peer support for those implementing the
PAT. The data regarding implementation progress and challenges from the calls will be
addressed in subsequent calls and will be considered in the development of the Toolkit.
Second, sites will identify a Champion for PAT implementation (Identify and Prepare
Champions), most likely be a division chief, nurse in a leadership role, or clinical
administrator.
At the Patient/Family level the following data for the English and Spanish versions of the
PAT will be reported monthly: new patients meeting eligibility requirements as outlined on
the PAT Implementation Plan (n); patients with documentation of PAT screening (n); patients
with evidence of family feedback letter (n); demographic data (race, ethnicity, zip code,
insurance). As part of the PAT Implementation Plan, the Site PI and Coordinator will
determine institution-specific ways to identify new patients and their demographic
characteristics.
At the Provider level the Site PI and staff identified as screeners will complete self-report
measures at baseline and at 6 and 12 months.
There are four outcomes at the Institution level. The first outcome is adoption, or the
intention of sites to use the PAT, by examining the site participation rate. To evaluate the
extent to which screening is perceived as an asset to the institution electronic health
record data (EHR) data will be extracted and aggregated at the site level for each family at
30, 60 and 90 days after screening. It provides a sum of hospital based services and external
referrals and the number and length of inpatient and outpatient visits, missed appointments
and evidence of non-adherence or difficulties in delivering care, allowing determination of
healthcare utilization or medical services delivered. Cost will be assessed to understand the
relationship among PAT risk level, psychosocial services provided, and aspects of medical
care that may reflect unnecessary or inefficient services. Because the care provided may be
related to the intensity of medical treatment, the Intensity of Treatment Scale will be used.
Analysis
H1. ANOVA will compare the effectiveness of the two implementation strategies on penetration
and health equity. The outcomes are proportions: families screened/families eligible,
families provided feedback/families screened, ethnic minority families screened/ethnic
minority families eligible, low socioeconomic status (SES) families screened/low SES families
eligible. Interclass Correlation Coefficients (ICC) among the clusters will be calculated and
used to adjust for the cluster effect.
H2. Three sets of outcome variables - perception of implementation, engagement in addressing
health disparities, and burnout/job satisfaction - will be tested. A two group analysis with
the framework of Structural Equation Modeling (SEM) will be conducted to compare the
effectiveness of the two strategies. To test the effect of time (T1, T2, T3), latent growth
curve analysis will be conducted; it is expected that provider outcomes will improve over
time. Analyses will be performed using Mplus 5.0 with ML estimation for outcome variables
that meet the distribution assumptions, and with Robust Least Weighted Squares (WLSMV)
estimation for outcome variables that do not. Potential mediating effects of favorable
perception of implementation on provider job satisfaction and burnout will be examined using
mediation models. TIER is expected to be associated with more favorable perceptions of
implementation, which in turn will lead to less burnout and higher job satisfaction.
H3. At the institution level adoption of the PAT will be measured by a ratio of sites that
initiate implementation/sites that agreed (H3a). If substitutions are necessary, sites that
are newly invited will be added to the denominator and adoption calculated by total
acceptances/total invited. ANOVA will be conducted to compare the effectiveness of the two
strategies. For H3b sustainability (PIQ perceptions of implementation benefits and
challenges), ANOVA will be conducted to compare the effectiveness of the two strategies on
benefits and challenges. For H3c the interest is in the extent to which psychosocial care is
matched to need and the extent to which intensive medical and psychosocial services are
delivered for those most in need. There has not yet been established a cost-effectiveness
threshold or criterion to which to compare costs of screening with these two implementation
strategies, necessitating our consideration of valued outcomes in the psychosocial screening
literature and resources available. ANOVA will be conducted to test whether psychosocial care
is matched with levels of psychosocial risks, resulting in a 2 (Strategy) x 3 (psychosocial
risks: clinical, targeted, universal) design on distribution of services and costs of care.
It is expected that the 3 levels of the Pediatric Psychosocial Preventative Health Model
(PPPHM) will be related to number and costs of services provided as measured on the
Psychosocial Services and Medical Treatment Checklist (PSMTC). Additional analyses will be
conducted to compare English speaking and Spanish speaking families, different ethnicity,
race, and SES and insurance status on the outcome variables.
