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| ID | Type | Description | Link |
|---|---|---|---|
| CDR-2018C3-14715 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily. Colorectal cancer screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). Screening rates go up when patients consider all these tests, not just colonoscopy. Informing patients about their options for CRC screening could produce higher quality decisions, improve the match between patient preferences and tests performed, and increase uptake of CRC screening. Decision aids (DAs) are a promising tool for accomplishing this goal. Also, precision CRC prevention - providing information about an individual's specific risk for CRC - has great promise to increase uptake and improve decision making.
Unfortunately, the COVID-19 pandemic is causing severe challenges to providing CRC screening and other prevention services. Health systems are trying to adapt, but these efforts have only begun and are poorly understood. Moreover, patient perceptions of disease risk and risk from COVID-19 are unknown.
The study team will engage with the leadership, staff, and providers in the study team's partner healthcare systems, to identify facilitators and barriers to implementing patient decision aids and provider notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for other evidence-based cancer screening during the COVID pandemic and, potentially, after the conclusion of the pandemic.
At the conclusion of the study, the investigators will have extensive information regarding how best to provide decision aids through an electronic health record (EHR) portal, with or without personalized information, and to deliver provider notifications, which can guide broader implementation.
The study will involve interviews with staff and providers at the study team's partner healthcare systems to identify facilitators and barriers to implementing decision aids and provider notifications for colorectal cancer screening.
Also, the investigators will interview patients to identify perceptions of prevention during the COVID-19 pandemic including risk perception and barriers to screening, perceptions of risk from both the pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in or postponed during the pandemic and patient rationales for their decisions. This part of the study will suggest potentially promising approaches for providing prevention and disease management during the COVID-19 pandemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthcare system leadership, providers, and staff | Leadership, providers, and staff at the study team's affiliated health systems. |
| |
| Patients receiving primary care at the study team's affiliated health systems | Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured interviews-Patients | Other | The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making. |
| Measure | Description | Time Frame |
|---|---|---|
| Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening. | Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening. | 2 years |
| Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff. | Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening. | 9 months |
| Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making. | 6 months |
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Inclusion Criteria:
Health system participants will be eligible if:
Patient participants will be eligible if:
Exclusion Criteria:
Patients will be excluded if:
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The participants will be health system primary care patients, and health system leadership, providers, or staff involved in primary care.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Schwartz, MD, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 462020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32749465 | Background | Kaufman HW, Chen Z, Niles J, Fesko Y. Changes in the Number of US Patients With Newly Identified Cancer Before and During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Netw Open. 2020 Aug 3;3(8):e2017267. doi: 10.1001/jamanetworkopen.2020.17267. | |
| 33558708 | Background | Castanon A, Rebolj M, Pesola F, Sasieni P. Recovery strategies following COVID-19 disruption to cervical cancer screening and their impact on excess diagnoses. Br J Cancer. 2021 Apr;124(8):1361-1365. doi: 10.1038/s41416-021-01275-3. Epub 2021 Feb 9. |
| Label | URL |
|---|---|
| Epic Health Research Network. Preventive Cancer Screenings during COVID-19 Pandemic. | View source |
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One patient that was consented, enrolled, and interviewed was removed from the study after review of data by PI and key research members concluded that the patient had undergone a diagnostic rather than screening procedure.
Healthcare system: we used snowball sampling to identify leadership, providers, and clinical staff involved in cancer screening, primary care and prevention. We interviewed 20 key informants in January-July 2021 and re-interviewed 11 of them in January-March 2022.
Patients: we interviewed patients (screened and not screened) who were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020. Interviews were conducted from August 2021 through February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthcare System Leadership, Providers, and Staff | Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic. |
| FG001 | Not Screened Patients | Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020, and did NOT complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making. |
| FG002 | Screened Patients | Patients who had at least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did completed the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Screened Patients | Patients who were due for cancer screening (breast, cervical, colorectal or lung cancer) between April-July 2020, however had not completed the screening they were selected for at time of interview. |
| BG001 | Screened Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic-age data for health system participants was not collected at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening. | Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening. | The initial sample of 8 interviewees identified 12 additional stakeholders, allowing us to "snowball" our sample to complete interviews with 20 participants including primary care providers, nurses, medical assistants, quality and clinic managers, and cancer screening program managers. | Posted | Number | Themes | 2 years |
|
Adverse events were monitored during the interviews. The time frame for patient participants was a one-time phone interview that lasted about 30 minutes. The interviews for health system participants lasted about 30-60 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthcare System Leadership, Providers, and Staff | Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic. |
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We involved just two healthcare systems in one Midwestern city. Our sample of interviewed leaders, providers, and staff may not have been representative of the entire organizations. Our method for identifying patients to interview did not include all patients at these health systems who were due for screening early in the pandemic, so we may have failed to include important perspectives or experiences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter H. Schwartz | Indiana University | 317-278-4037 | phschwar@iu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2020 | Jul 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2020 | Jul 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Semi-structured interviews-Health system | Other | The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic. |
|
| 33914015 | Background | Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of Cancer Screening Deficit in the United States With the COVID-19 Pandemic. JAMA Oncol. 2021 Jun 1;7(6):878-884. doi: 10.1001/jamaoncol.2021.0884. |
| 34079764 | Background | Alkatout I, Biebl M, Momenimovahed Z, Giovannucci E, Hadavandsiri F, Salehiniya H, Allahqoli L. Has COVID-19 Affected Cancer Screening Programs? A Systematic Review. Front Oncol. 2021 May 17;11:675038. doi: 10.3389/fonc.2021.675038. eCollection 2021. |
| 32915166 | Background | Czeisler ME, Marynak K, Clarke KEN, Salah Z, Shakya I, Thierry JM, Ali N, McMillan H, Wiley JF, Weaver MD, Czeisler CA, Rajaratnam SMW, Howard ME. Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1250-1257. doi: 10.15585/mmwr.mm6936a4. |
| 36218479 | Background | Findling MG, Blendon RJ, Benson JM. Delayed Care with Harmful Health Consequences-Reported Experiences from National Surveys During Coronavirus Disease 2019. JAMA Health Forum. 2020 Dec 1;1(12):e201463. doi: 10.1001/jamahealthforum.2020.1463. No abstract available. |
| 35977302 | Background | Park S, Stimpson JP. Trends in Self-reported Forgone Medical Care Among Medicare Beneficiaries During the COVID-19 Pandemic. JAMA Health Forum. 2021 Dec 30;2(12):e214299. doi: 10.1001/jamahealthforum.2021.4299. eCollection 2021 Dec. |
| 34062813 | Background | Lieneck C, Herzog B, Krips R. Analysis of Facilitators and Barriers to the Delivery of Routine Care during the COVID-19 Global Pandemic: A Systematic Review. Healthcare (Basel). 2021 May 1;9(5):528. doi: 10.3390/healthcare9050528. |
| Background | Aitken M, Kleinrock M. Shifts in Healthcare Demand, Delivery and Care During the COVID-19 Era. Published online 2020. https://www.iqvia.com/insights/the-iqvia-institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era |
| 28483887 | Background | Powell RE, Henstenburg JM, Cooper G, Hollander JE, Rising KL. Patient Perceptions of Telehealth Primary Care Video Visits. Ann Fam Med. 2017 May;15(3):225-229. doi: 10.1370/afm.2095. |
| 35313453 | Background | Price ST, Mainous AG, Rooks BJ. Survey of cancer screening practices and telehealth services among primary care physicians during the COVID-19 pandemic. Prev Med Rep. 2022 Mar 17;27:101769. doi: 10.1016/j.pmedr.2022.101769. eCollection 2022 Jun. |
| 33784177 | Background | Basu P, Alhomoud S, Taghavi K, Carvalho AL, Lucas E, Baussano I. Cancer Screening in the Coronavirus Pandemic Era: Adjusting to a New Situation. JCO Glob Oncol. 2021 Mar;7:416-424. doi: 10.1200/GO.21.00033. |
| 33027039 | Background | Cancino RS, Su Z, Mesa R, Tomlinson GE, Wang J. The Impact of COVID-19 on Cancer Screening: Challenges and Opportunities. JMIR Cancer. 2020 Oct 29;6(2):e21697. doi: 10.2196/21697. |
| 34995027 | Background | Horn DM, Haas JS. Expanded Lung and Colorectal Cancer Screening - Ensuring Equity and Safety under New Guidelines. N Engl J Med. 2022 Jan 13;386(2):100-102. doi: 10.1056/NEJMp2113332. Epub 2022 Jan 8. No abstract available. |
| 33170520 | Background | Gorin SNS, Jimbo M, Heizelman R, Harmes KM, Harper DM. The future of cancer screening after COVID-19 may be at home. Cancer. 2021 Feb 15;127(4):498-503. doi: 10.1002/cncr.33274. Epub 2020 Nov 10. |
| Background | Frey B. Snowball Sampling. In: The SAGE Encyclopedia of Educational Research, Measurement, and Evaluation. 2018. https://dx.doi.org/10.4135/9781506326139.n636 |
| Background | Beebe J. Rapid Qualitative Inquiry: A Guide to Team Based Assessment.; 2014. |
| 30709368 | Background | Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y. |
| 34215286 | Background | Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5. |
| 30297341 | Background | Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018 Oct 8;8(10):e019993. doi: 10.1136/bmjopen-2017-019993. |
| Centers for Medicare and Medicaid Centers for Medicare and Medicaid Services (CMS). Medicare telemedicine snapshot: Medicare claims and encounter data: March 1, 2020 to February 28, 2021. Received by September 9, 2021. | View source |
Patients who were due for cancer screening (breast, cervical, colorectal or lung cancer) between April-July 2020 and had completed the screening they were selected for at time of interview. |
| BG002 | Health System Participants | Leadership, providers, and clinical staff involved in cancer screening, primary care, and prevention at two affiliated health systems. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Demographic-sex/gender data for health system participants was not collected at baseline. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Demographic-race and ethnicity data for Health system participants was not collected at baseline. | Count of Participants | Participants |
|
| Living Situation | Living situation data will not be collected for health system participants. | Count of Participants | Participants |
|
| Highest Level of Education | Education level will not be collected for health system participants. | Count of Participants | Participants |
|
| Employment Status | Employment status data will not be collected from health system participants. | Count of Participants | Participants |
|
| Subjective Health Status | Subject Health Status data will not be collected from health system participants. | Count of Participants | Participants |
|
| Subjective Income | Subjective Income data will not be collected from health system participants. | Count of Participants | Participants |
|
| Difficulty Understanding Written Information | Health literacy data will not be collected from health system participants. | Count of Participants | Participants |
|
| Confidence Filling Out Medical Forms | Health literacy data will not be collected from health system participants. | Count of Participants | Participants |
|
| Have Help Reading Hospital Materials | Health literacy data will not be collected from health system participants. | Count of Participants | Participants |
|
| Health System Roles | Health system role data was only collected from health system participants. | Count of Participants | Participants |
|
|
|
| Primary | Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff. | Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening. | 20 leaders, managers, and providers were interviewed in January-July 2021, and 11 were re-interviewed in January-March 2022. We identified five emergent, overarching themes of the impact of COVID-19 pandemic on cancer screening and preventive care services across two healthcare organizations and across the time frame of the COVID-19 pandemic (2020-2022). | Posted | Number | Themes | 9 months |
|
|
|
| Primary | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making. | We interviewed 32 patients who completed screening in 2020 and 29 patients who did not complete the relevant screening test from April 2020 to the date of the interview. | Posted | Number | Themes | 6 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Not Screened Patients | Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did NOT complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Screened Patients | Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did complete the screening they were selected for at the time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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