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临床试验/NCT04763824
NCT04763824已完成不适用

KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Tumor Surveillance Completion (Pre-Intervention)

研究概览

简要总结

Approximately, 20 rural primary care practices to participate in a delayed intervention-controlled trial.

Phase I: Formal and structured work flow evaluations to better identify specific gaps in processes of care while assessing what on-going training is needed for adoption of high-quality cancer survivorship care in rural practice. These will be incorporated into the ECHO sessions (Aim 1).

Phase II: Conduct and test the effectiveness of the novel KanSurvive-ECHO intervention (Aim 2) and finally identify barriers and facilitators to implementation of KanSurvive-ECHO (Aim 3).

详细描述

While evidence-based practice (EBP) guidelines exist for cancer survivorship care, implementation in rural practices has fallen short. Approximately 72.5% of Kansas cancer survivors who have completed their cancer treatment receive a majority of their health care from Primary Care Providers, yet these providers describe a lack of basic awareness of risk-based surveillance, effects of cancer treatment and their management, as well as inadequate resources, and growing administrative demands as reasons for not working to improve survivorship care. These factors may also prevent shared care management of cancer survivors between primary care and rural oncology care providers. There is a pressing need to understand primary care practice capacity to implement guideline informed management and follow-up for cancer survivors in the acute and extended phases of care.

Specific Aim 1. Formally assess gaps in processes of care and additional training needed to result in actual adoption of high-quality care for acute and chronic survivors of breast, colorectal, lung, and prostate cancer in 20 rural primary care practices. Utilize this formative information to further refine the KanSurvive-ECHO.

Specific Aim 2. Evaluate the effectiveness of KanSurvive-ECHO for enhancing evidence-based survivorship care for rural breast, colorectal, lung, and prostate cancer survivors.

Hypothesis: Compared to delayed intervention control, rural primary care practices randomized to KanSurvive-ECHO will demonstrate greater concordance with evidence-based survivorship care guidelines as measured by a composition score determined by change in EHR documentation consistent with guideline concordant care.

Specific Aim 3: Utilizing the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework describe key facilitators and barriers to implementation of KanSurvive-ECHO including innovation, recipients, context, and facilitation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary care practice (PCP) caring for rural cancer survivors
  • Willing to participate in four ECHO sessions
  • Capable and willing to complete pre- and post- data collection under a data use agreement
  • Cancer survivor data is eligible for extraction if the patient is a breast, prostate, lung, and/or colorectal cancer survivor and considered to have a "reasonable likelihood" of 24-month survival by a practice provider.

排除标准

  • PCPs unwilling to engage in project activities
  • PCPs with no rural-dwelling patients on their patient panel
  • Cancer survivor data is ineligible for extraction if the patient is <18 years of age or >75 years of age, is currently receiving hospice services, or has a history of cancer other than breast, prostate, lung, or colorectal.

研究组 & 干预措施

KanSurvive Telementoring with Practice Facilitation

Other

This study does not involve a therapeutic intervention.

The KanSurvive project includes Project ECHO telementoring and education with practice facilitation to improve the delivery of cancer survivorship care in primary care practice.

干预措施: KanSurvive ECHO and Practice Facilitation (Other)

结局指标

主要结局

Tumor Surveillance Completion (Pre-Intervention)

时间窗: Baseline (Pre-Intervention) Chart Audit

This outcome reflects whether recommended tumor surveillance was completed and documented in the EHR. Tumor surveillance includes cancer-specific follow-up imaging consistent with evidence-based survivorship guidelines (e.g., NCCN, ASCO). Charts were coded as "Completed" if the recommended surveillance test was documented within the appropriate interval and "Not Completed" if documentation was absent, outdated, or incomplete. The outcome reports the proportion of EHR charts meeting tumor surveillance recommendations at baseline (pre-intervention) and again 24 months after the intervention.

Tumor Surveillance Completion (Post-Intervention)

时间窗: 24-Month Follow-Up (Post-Intervention) Chart Audit

This outcome reflects whether recommended tumor surveillance was completed and documented in the EHR. Tumor surveillance includes cancer-specific follow-up imaging consistent with evidence-based survivorship guidelines (e.g., NCCN, ASCO). Charts were coded as "Completed" if the recommended surveillance test was documented within the appropriate interval and "Not Completed" if documentation was absent, outdated, or incomplete. The outcome reports the proportion of EHR charts meeting tumor surveillance recommendations at baseline (pre-intervention) and again 24 months after the intervention.

Distress Screening Completion (Pre-Intervention)

时间窗: Baseline (Pre-intervention) Chart Review

This outcome reflects whether recommended Distress Screening was completed and documented in the EHR. Distress Screening was defined as documentation of using a standardized distress assessment tool consistent with survivorship best practices. Charts were coded as "Completed" when a distress screening result was documented during the chart abstraction interval. "Not Complete" indicated missing or incomplete documentation.

Distress Screening Completion (Post-Intervention)

时间窗: 24-Month Follow-Up (Post-Intervention) Chart Audit

This outcome reflects whether recommended Distress Screening was completed and documented in the EHR. Distress Screening was defined as documentation of using a standardized distress assessment tool consistent with survivorship best practices. Charts were coded as "Completed" when a distress screening result was documented during the chart abstraction interval. "Not Complete" indicated missing or incomplete documentation.

Body Mass Index (BMI) Assessment Completion (Pre-Intervention)

时间窗: Baseline (Pre-intervention) Chart Review

BMI assessment was defined as documentation of a height and weight measurement sufficient to calculate body mass index (BMI) in the electronic health record (EHR). Charts were coded as "Completed" when BMI or its components were documented within the recommended timeframe.

Body Mass Index (BMI) Assessment Completion (Post-Intervention)

时间窗: 24-Month Follow-Up (Post-Intervention) Chart Audit

BMI assessment was defined as documentation of a height and weight measurement sufficient to calculate body mass index (BMI) in the electronic health record (EHR). Charts were coded as "Completed" when BMI or its components were documented within the recommended timeframe.

Tobacco Use Screening Completion (Pre-Intervention)

时间窗: Baseline (Pre-Intervention) Chart Audit

Tobacco use screening was defined as documentation of current tobacco use status in the electronic health record (EHR). Charts were coded as "Completed" when a screening result was documented within the recommended timeframe.

Tobacco Use Screening Completion (Post-Intervention)

时间窗: 24-Month Follow-Up (Post-Intervention) Chart Audit

Tobacco use screening was defined as documentation of current tobacco use status in the electronic health record (EHR). Charts were coded as "Completed" when a screening result was documented within the recommended timeframe.

Cancer Diagnosis on Problem List (Pre-Intervention)

时间窗: Baseline (Pre-Intervention) Chart Audit

This outcome reflects whether a cancer diagnosis was documented on the patient's EHR problem list, consistent with survivorship care documentation standards. Charts were coded as "Completed" when the cancer diagnosis appeared in the structured problem list.

Cancer Diagnosis on Problem List (Post-Intervention)

时间窗: 24-Month Follow-Up (Post-Intervention) Chart Audit

This outcome reflects whether a cancer diagnosis was documented on the patient's EHR problem list, consistent with survivorship care documentation standards. Charts were coded as "Completed" when the cancer diagnosis appeared in the structured problem list.

Family History of Cancer Documentation (Pre-Intervention)

时间窗: Baseline (Pre-intervention) Chart Audit

Family history of cancer documentation was defined as the presence of cancer-related family history information in the EHR. Charts were coded as "Completed" when documentation included a family history of cancer assessment entry.

Family History of Cancer Documentation (Post-Intervention)

时间窗: 24-Month Follow-Up (Post-Intervention) Chart Audit

Family history of cancer documentation was defined as the presence of cancer-related family history information in the EHR. Charts were coded as "Completed" when documentation included a family history of cancer assessment entry.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Klemp, PhD, MA, MPH

Professor

University of Kansas Medical Center

研究点 (1)

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