Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05645328 |
| Other study ID # |
202202104 |
| Secondary ID |
R01CA254628 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2023 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
University of Iowa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to implement and evaluate the recently developed Iowa Cancer
Affiliate Network (ICAN) intervention.
The ICAN intervention will consist of members of the research team providing ongoing support
to participating hospitals in achieving the quality standards outlined by the American
College of Surgeons Commission on Cancer (CoC). Support will be offered in the form of
education and training regarding the standards and provision of cancer services, regular
in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision
of documentation and educational resources regarding standard requirements.
Implementation approach:1) Engage implementation teams and develop and execute implementation
plans based on hospital needs assessments; and 2) Conduct interviews with key ICAN
stakeholders to assess acceptability, adoption, appropriateness and cost (based on Proctor's
implementation outcomes framework) and determinants of these outcomes (e.g., hospital
structure, culture, resources, capacity, readiness) based on the Consolidated Framework for
Implementation Research.
Evaluation approach: Using Iowa Cancer Registry data routinely collected for surveillance
purposes, the investigators will compare rates of compliance with pre- and post-intervention
treatment-related quality measures in target and control hospitals. The rural hospitals in
Iowa that serve the most rural cancer patients and have never been accredited by the CoC were
chosen for intervention targets, and all committed to participating in the study (letters of
support provided). The remainder of rural hospitals that care for >100 newly diagnosed cancer
patients per year (n=5) were chosen as a comparison group. The investigators will use data
routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality
measures for cancer care between the hospitals included in the intervention and comparison
group hospitals using a difference-in-difference estimator. In addition, the investigators
will conduct interviews with representatives from intervention hospitals to assess the extent
to which ICAN hospitals implemented the CoC standards of cancer care.
Description:
Intervention: The investigators received letters of support from hospitals, and those who
direct the cancer center staff have expressed their willingness to participate on behalf of
their staff. This is a health-system-level intervention, designed as single-arm intervention
trial, where five participating hospitals will be offered support in the areas of training
and education, cancer data collection and reporting, quality improvement and clinical
peer-to-peer support.
The ICAN intervention was developed through implementation science processes as an adaptation
of the Markey Cancer Center Affiliate Network (MCCAN) with retention of identified core
functions. Each hospital in the intervention arm has undergone interviews about their current
cancer program needs and offerings. From the information gathered through these meetings, the
investigators established baseline understandings of cancer centers and their services.
Through these meetings, the investigators elicited program goals, challenges, and readiness
for change within their cancer services. Prior to starting the ICAN intervention, the cancer
centers will be provided a documentation specifying current status for meeting CoC
accreditation standards, gaps identified, suggestions and resources for the next steps to
meet goals, and progress toward fulfilling CoC accreditation standards. Through the
intervention, each of the five hospitals will be offered support, expertise, and resources
necessary to facilitate hospitals in achieving the standards set forth by the American
College of Surgeons Commission on Cancer. Support will be offered in the form of education
and training regarding the standards and provision of cancer services, regular in-person and
zoom check-ins with hospital stakeholders to evaluate progress, and provision of
documentation and educational resources regarding standard requirements. The specific
intervention actions will be tailored to the needs identified for each hospital or health
system based on particular standards they currently do not meet and choose to work toward.
4 years from the start of the intervention, the investigators will use Iowa Cancer Registry
data to evaluate the success of the intervention by comparing rates of compliance with pre-
and post-intervention treatment-related quality measures in target and control hospitals
using a difference-in-difference estimator. The rural hospitals in Iowa that serve the most
rural cancer patients (all care for >100 newly diagnosed cancer patients per year) and have
never been accredited by the CoC were chosen for intervention targets. The remainder of rural
hospitals that care for >100 newly diagnosed cancer patients per year (n=4) were chosen as a
comparison group. They were not contacted, as they will not be providing us with any data.
Rather, the investigators will use data routinely collected by the Iowa Cancer Registry to
compare aggregate compliance with quality measures for cancer care between the hospitals
included in the intervention and hospitals that were not.
These variables needed to compute compliance with quality measures by hospital are routinely
collected by the Iowa Cancer Registry from all hospitals in Iowa as part of routine public
health surveillance. The investigators will only be using data provided to us by the Iowa
Cancer Registry to calculate these measures for both intervention and control hospitals and
will not be accessing medical record data from the intervention or control hospitals.
Interviews: Subjects from intervention hospitals will be asked to reply to the recruitment
email and provide times over the subsequent two weeks that would for them to participate in a
one-time audio/video-recorded telephone interview which will take approximately 30-45
minutes. Subjects will be asked prior to recording whether recording is permitted. If
permitted, the interview will be recorded on zoom and converted to an audio file using UI
(University of Iowa)-Capture. The recordings will be used to audio-transcribe the interview
so that they transcript can be used in qualitative data-analysis. Only members of the
research team will have access to the recordings. The audio-transcriptions will be done using
the web-based service Rev.com. The recordings will be destroyed on completion of the
data-analysis. The interview will include questions about the culture, structure, changes and
current processes at their hospital for providing cancer care and the impact of the
intervention. They will be mailed a $50 check in appreciation of their time after the
interview has been conducted. There will be no additional follow-up to the interviews.
