Getting To Implementation: Comparing the Effectiveness of Implementation Strategies to Improve Cancer Screening for Veterans
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30,300
- 试验地点
- 1
- 主要终点
- Change in Reach of HCC screening from Baseline to 12 months
研究概览
简要总结
Gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the US. Testing could catch these cancers early, helping people live longer. The goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing.
The main question it aims to answer is: how should healthcare systems go about choosing one or the other?
Researchers will look at cancer testing rates over time at sites that are trying these different approaches. They will also survey and interview participants from these sites.
详细描述
Researchers will conduct two hybrid type 3, cluster-randomized trials to compare the effectiveness of Patient Navigation (PN) and Implementation Facilitation (IF) on hepatocellular cancer (HCC) and colorectal cancer (CRC) screening completion. Trials will enroll 24 sites for the HCC arm and 32 sites for the CRC arm, passively enrolling and cluster-randomizing Veterans by their site of primary care. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will also be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants. Comparing findings in the two trials will allow researchers to understand how the barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Enrolled in Veterans Health Administration (VA)
- •Have ≥1 VA encounter in the prior 18 months
- •Hepatocellular cancer (HCC) screening subgroup: Diagnosis of cirrhosis in electronic medical record
- •Colorectal cancer (CRC) screening subgroup: ≥45 years of age, positive fecal immunochemical test (FIT) (or other screening stool test) in the last 18 months
- •Healthcare provider or related staff at participating VA site or engaged in CRC or HCC screening pathways in an included VA site (e.g., scheduling)
- •≥18 years of age
排除标准
- •<18 years of age
- •Not enrolled in VA
- •No VA encounters in the prior 18 months
- •Limited life expectancy (< 6 months), defined as having a code for hospice
- •Members of the study team will not participate, even if their sites are recruited
研究组 & 干预措施
Implementation Facilitation (IF)
Half of the HCC sites and half of the CRC sites will be randomized to IF delivered by 2 facilitators (one clinical and one evaluation expert) per site.
干预措施: Implementation Facilitation (Behavioral)
Patient Navigation (PN)
Half of the HCC sites and half of the CRC sites will be randomized to PN.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Change in Reach of HCC screening from Baseline to 12 months
时间窗: Baseline, 12 months from Baseline
Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of eligible Veterans in the HCC screening subgroup receiving guideline-concordant abdominal imaging within the prior 6 months.
Change in Reach of CRC screening from Baseline to 12 months
时间窗: Baseline, 12 months from Baseline
Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of eligible Veterans in the CRC screening subgroup receiving a colonoscopy.
次要结局
- Effectiveness of screening - Change in time to treatment from Baseline to 12 months(Baseline, 12 months from Baseline)
- Change in Adoption of screening from Baseline to 12 months(Baseline, 12 months from Baseline)
- Fidelity - Proportion of Veterans receiving recommended screening(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12)
- Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM)(12 months from Baseline)
- Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months(Baseline, 12 months from Baseline)
- Acceptability assessed by the Acceptability of Intervention Measure (AIM)(12 months from Baseline)
- Appropriateness assessed by the Intervention Appropriateness Measure (IAM)(12 months from Baseline)
- Maintenance of HCC Screening at 18 and 24 months from Baseline(6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline))
- Maintenance of CRC Screening at 18 and 24 months from Baseline(6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline))
研究者
Shari Rogal
Professor
University of Pittsburgh