This is a health-system-level intervention, designed as two-arm intervention trial, where four 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.

Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. We selected 4 of the 9 rural hospitals meeting this criteria to administer the intervention.

Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. The remaining 5 hospitals meeting this criteria that were not selected for the intervention will serve as controls.

Each hospital in the intervention has undergone interviews in which the investigators elicited program goals, challenges, and readiness for change. Prior to the intervention, the cancer centers will be provided a document specifying current status for meeting Commission on Cancer (CoC) accreditation standards, gaps identified, suggestions and resources for the next steps to meet goals, and progress toward fulfilling CoC accreditation standards. The hospitals will be offered support, expertise, and resources to facilitate them in achieving the CoC standards. Support will be offered in the form of education/training regarding the standards and provision of cancer services, regular in-person/zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation/educational resources regarding standard requirements. The intervention actions will be tailored to the needs of each hospital based on standards they currently do not meet and choose to work toward.

Iowa Cancer Affiliate Network (ICAN)

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.

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.

Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural Patients

Effectiveness and Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural, Underserved Patients

primary quality measure for breast cancer: percent of patients receiving tamoxifen or 3rd gen aromatase inhibitor within 1 year of diagnosis for women with T1cN0M0 or stage IB-III hormone receptor-positive cancer

primary quality measure for colon cancer: percent of patients having \>12 regional lymph nodes removed and examined

percent of patients receiving radiation within 1 year of diagnosis for women \<70 years old receiving breast conserving surgery for breast cancer

percent of patients receiving combination chemomotherapy within 4 months of diagnosis for women \<70 years old with T1cN0M0 or stage IB-III hormone receptor-negative breast cancer

percent of patients receiving adjuvant chemotherapy within 4 months of diagnosis for patients \<80 years old with AJCC Stage III (lymph node positive) colon cancer

Number and percentage of the 38 evidence-based CoC standards being met by each hospital

National Cancer Institute (NCI)

Mary Charlton

Associate Professor

The CP-CDS group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.

The CP-CDS + SDMT group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The CP-CDS + SDMT arm also provides shared decision making tools to patient and provider at the time of the visit.

The usual care group will have no access to the CP-CDS, or the CP-CDS + SDMT.

The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

CP-CDS

Thomas E Elliott, MD

The objective of this project is to implement and evaluate the effectiveness of a sophisticated Web-based, electronic health record (EHR)-linked clinical decision support (CDS) system designed to improve primary and secondary cancer preventive care.

This project will engage a rural population with substantial healthcare disparities and gaps in the receipt of primary and secondary cancer prevention. Results will advance dissemination and implementation research methods that can reduce health disparities and improve healthcare for millions in medically under-served areas.

The objective of this project is to implement and evaluate the effectiveness of a sophisticated Web-based, electronic health record (EHR)-linked clinical decision support (CDS) system designed to improve primary and secondary cancer preventive care. To achieve this objective, EHR data is sent to evidence-based cancer prevention algorithms, housed on a secure Web site. The algorithms: (a) identify at the point of care all eligible patients not up to date on their cancer prevention interventions; and (b) present to both patient and primary care provider (PCP), appropriate evidence-based primary cancer prevention interventions and cancer screening options at the point of care. The cancer prevention (CP)-CDS will focus on breast cancer screening in women aged 50-74, colorectal cancer screening for both sexes aged 50-75, cervical cancer screening for women aged 21-65, human papilloma virus (HPV) vaccination for both sexes aged 11-26, and referrals for weight management and smoking cessation in all adults aged 18 and older. Effectiveness is assessed by cluster-randomizing 30 primary care clinics with roughly 285 PCPs and 153,000 study-eligible patients into one of three experimental conditions: Group 1: CP-CDS intervention in which the decision support is printed for the PCP and patient, designed to engage patients in discussions about appropriate cancer prevention strategies. Group 2: CP-CDS + shared decision making tools (SDMT) intervention in which the CP-CDS is printed along with additional shared decision making tools. Group 3: clinics provide usual care (UC) with no intervention-related activity related to cancer prevention.

With 10 clinics, 95 PCPs, and 51,000 potentially eligible patients per study arm, this study will formally test the hypothesis that Groups 1 and 2 are superior to Group 3 over an 12-month follow-up period with respect to: (a) significantly higher rates of appropriate screening for breast, cervix, and colorectal cancer, as defined by the United States Preventive Services Task Force; and (b) significantly higher rates of human papillomavirus (HPV) vaccination in males and females aged 11-26 years. Secondary analysis will evaluate the impact of the intervention on lung cancer screening. The investigators further posit that Groups 1 and 2 will have higher short-term health care costs but better long-term cost-effectiveness than Group 3. The Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) conceptual frameworks will be used to guide implementation planning, organization, conduct, and impact evaluation of the intervention in a large rural healthcare system.

This project will engage a rural population with substantial healthcare disparities and gaps in the receipt of primary and secondary cancer prevention. Results will advance dissemination and implementation research methods that can reduce health disparities and improve healthcare for millions in medically under-served areas.

Cancer Prevention Clinical Decision Support

Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support

Participants up to date on composite endpoint of breast, cervical, and colorectal cancer screening at 1 year post index date.

Participants up to date on HPV vaccination at 1 year post index date.

Participants up to date on lung cancer screening at 1 year post index date.

HealthPartners Institute

This is a minimal risk study designed to improve cancer screening rates. Feedback from providers on the CDS tool was monitored and printing rates for the CDS interface were monitored.

Providers in the PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Providers in the SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

CP-CDS + SDMT

Providers practicing at clinics assigned to the usual care arm will have no access to the CP Wizard.

Usual Care

Providers practicing in the PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Providers practicing in the SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Analysis population included patients not up to date on one or more composite screening for breast, cervical, or colorectal cancer, HPV vaccine, or lung cancer screening.

The study was conducted at one relatively high-performing predominantly rural healthcare system, and generalizability of results to other care systems or patient populations is uncertain. The intervention was delivered during clinic encounters with primary care providers; the impact of the clinical decision support delivered in other clinical venues or directly to patients using mobile health technologies may be greater or less than what we observed.

Dr. Tom Elliott

Generalized linear mixed models with logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index for breast, cervical, and colorectal cancer. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two contrasts were 2-sided with P-values \< 0.025 considered statistically significant.

Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index date for breast, cervical, and colorectal cancer. Model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in randomization process. Tests of the planned contrasts were 2-sided with P-values \< 0.025 considered statistically significant.

The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Analysis population included adult patients ages 21-75 who had a visit at a study clinic over the accrual period, and who were due for one or more breast, cervical, or colorectal cancer screening test.

Composite Cancer Screening Tests up to Date

Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.

Young adults ages 18-26 with a visit at a study clinic during the accrual period, and not up to date on HPV vaccination.

HPV Vaccination up to Date

Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of lung cancer screening by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.

Generalized linear mixed models with a logit link and binomial error distribution were used to test the intervention effect on the completion of lung cancer screening by 12 months post-index. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.

Adult patients with a visit at a study clinic and not up to date for lung cancer screening at index date.

Lung Cancer Screening up to Date

The CP-CDS group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

The SDMT-focused group will receive the point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.

CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Patients of providers practicing at clinics assigned to the usual care arm will have no access to the CP-CDS or CP-CDS + SDMTs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural Patients	NCT05645328	Cancer	Iowa Cancer Aff...	18 Years - 100 Years	University of Iowa
Cancer Prevention Clinical Decision Support	NCT02986230	Cancer Preventi...	CP-CDS	18 Years - 80 Years	HealthPartners Institute

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