Initiating Colorectal Cancer Screening in Unscreened Individuals 45 to 54
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measurement of acceptability and feasibility of implementation strategies
研究概览
简要总结
The goal of this observational study is to understand the barriers and facilitators to completing colorectal cancer screening from the patient and community health center staff perspective. The main question it aims to answer is to identify system-level determinants of colorectal cancer screening in individuals aged 45 to 54. Participants will be asked to partake in one-time interviews either online or in-person and community health center staff will also be asked to take an online survey.
详细描述
AIM 1: Identify system-level determinants of CRC screening in individuals age 45 to 54 using mixed methods.
A. Overview: The objective of this aim is to identify systems-level determinants of CRC screening in unscreened individuals age 45 to 54 at CSHC using the CFIR framework. We will work with Dr. Rachel Hindin, our clinical champion, to: (1) conduct a validated organizational survey with staff and providers and connect to patient-level EHR data to quantitatively assess systems-level determinants of screening; (2) conduct in-depth interviews with patient-facing CHC staff and providers; and (3) conduct in-depth interviews with patients.
B. Approach: B.1. Organizational Survey: Participants and recruitment: The organizational survey will be conducted at CSHC and 9 other CHCs, which will allow us to gather generalizable information about systems-level determinants of screening (n(CHCs) = 10; n(survey participants) = 50; n=5 staff and providers directly involved in CRC screening per CHC). Eligible staff at CHCs will be identified by our staff contact at each CHC.
Procedures: We will use a validated survey previously developed by ISCCCE, to collect data on systems-level factors that contribute to CRC screening. The survey collects data on CFIR inner setting constructs at the CHC including human resources practices, learning climate, available resources, patient needs and resources, linguistic services, implementation demands, and leadership engagement. Survey data will be collected via RedCap. Electronic informed consent will be obtained prior to each survey. Written or phone surveys (written or verbal consent) will be offered to those unable to provide electronic responses. We will connect survey data with patient DRVS data and fit models to quantitatively determine independent systems-level determinants of CRC screening. We will collect data across 10 ISCCCE partner sites which will also allow us to identify sites within the Mass League with similar contexts for testing in my future R01 and to maximize generalizability.
Data Analysis: Characteristics will be measured using a 5-point Likert scale with a "1" rating meaning strongly disagree and "5" rating meaning "strongly agree." Scores across responses will be collected as mean and standard deviations, and an aggregate score will be created by averaging survey responses pertaining to each characteristic. Generalized linear mixed effect models will be used to examine the outcome of CRC screening (yes/no) as function of patient demographics (first level) and inner setting survey construct scores (second level). Findings from the organizational survey will be used to adapt staff and patient interview guides to allow us to dive deeper into findings from the survey. Prior to the start of analysis, I will complete coursework in multilevel modeling under the guidance of Dr. Chan.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 54 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 45-54
- •Individuals who are patients at the health center
- •Individuals that are willing and able to give verbal/written consent
排除标准
- •Individuals with a personal history of CRC
- •Individuals with a family history of CRC
- •Individuals with a history of inflammatory bowel disease or high-risk cancer syndrome
- •Inclusion Criteria:
- •Individuals ages 18+
- •Individuals working at the health center
- •Individuals that are involved in CRC screening processes at CSHC
- •Individuals that are willing and able to give verbal/written consent
结局指标
主要结局
Measurement of acceptability and feasibility of implementation strategies
时间窗: From planning to testing and evaluation and assessment of outcomes will be a total of 12 months
For our primary outcome, participants will be asked to rate the acceptability and feasibility of implementation strategies using a previously validated instrument, which the investigator previously used with CHC staff. This tool has demonstrated good internal consistency reliability (0.85 for acceptability and 0.89 for feasibility) and similarly good test-retest reliability (correlations: acceptability- 0.80; feasibility - 0.88) and validity in a known groups analysis. There are no cut off numbers for acceptability and feasibility as these are just means but higher scores reflect higher acceptability. However, our surveys will allow us to better understand our survey findings. Quantitative survey interviews will be collected after first and second cycle of testing. The surveys and interviews will be measured together as this is a mixed methods study.
次要结局
- Measurement of reach, effectiveness, and maintenance of implementation strategies(From planning to testing and evaluation and assessment of outcomes will be a total of 12 months)
研究者
Adjoa Anyane-Yeboa, M.D.
Principal Investigator
Massachusetts General Hospital
