Clinical trial NCT05645328: Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural Patients
Official title: Effectiveness and Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural, Underserved Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Health system intervention
Rural health
Quality improvement
Implementation science
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Administrators, clinicians, and data monitoring staff who help provide cancer related care at one of the four hospitals that have been included in our study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Compliance with CoC quality of cancer care measures: Hormone therapy (HT)
timeFrame: 36 months post implementation of intervention
measure: Compliance with CoC quality of cancer care measures: 12 regional lymph nodes (12RLN)
timeFrame: 36 months post implementation of intervention
Secondary outcomes:
measure: Compliance with CoC quality of cancer care measures: Breast conserving surgery radiation therapy (BCSRT)
timeFrame: 36 months post implementation of intervention
measure: Compliance with CoC quality of cancer care measures: Multi-agent chemotherapy (MAC)
timeFrame: 36 months post implementation of intervention
measure: Compliance with CoC quality of cancer care measures: Adjuvant chemotherapy (ACT)
timeFrame: 36 months post implementation of intervention
measure: Percentage of CoC evidence-based standards of cancer care implemented
timeFrame: 36 months post implementation of intervention
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: