An Interactive Preventive Health Record to Increase Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 683
- 试验地点
- 2
- 主要终点
- CRCS adherence provided by the electronic medical record
研究概览
简要总结
This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 50-75 years
- •Non-adherent to CRCS guidelines (i.e., no FOBT in last year, no sigmoidoscopy or barium enema in last 5 years, and no colonoscopy in last 10 years)
- •English-speaking
- •Have computer access (e.g. home, work, library)
- •Additional eligibility for Phase I: focus group participants will be ineligible for the subsequent prototype testing and cognitive/usability testing interviews
- •Additional eligibility for Phase I: prototype testing participants will be ineligible for the cognitive/usability testing interviews
- •Additional eligibility for Phase II: Seen in the clinic in the last 2 years
排除标准
- •Personal CRC history
- •Additional exclusion for Phase III: Patients seen at any clinic participating in Phase II
研究组 & 干预措施
Phase II: MyCRCS+Prefs
Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies.
Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+ arm in its entirety will be 5-7 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.
干预措施: MyCRCS+Prefs (Behavioral)
Phase II: MyCRCS+Prefs+Barriers
Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3 test-specific barriers/concerns in "real time".
Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers
干预措施: MyCRCS+Prefs+Barriers (Behavioral)
Phase II: Usual Care
The IPHR will be programmed so that where the IPHR-CRCS would normally present patients, who based on their demographics and health conditions, with content advising them to seek CRCS and links to third-party sites, they would instead be randomized to receive the usual care (IPHR-CRCS).
结局指标
主要结局
CRCS adherence provided by the electronic medical record
时间窗: Phase III: Baseline up to 12 months post intervention
Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.
CRCS adherence provided by the electronic medical record
时间窗: Phase II: Baseline up to 12 months post randomization
Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.
次要结局
- EHR Paradata(Phase III: Continuous)
- Self-reported CRCS adherence(Phase III: Baseline and 9 months post intervention)
- Psychosocial Constructs(Phase III: Baseline and 9 months post intervention)
- General and test-specific colorectal cancer screening barriers(Phase III: Baseline and 9 months post intervention)
- Feasibility of MyCRCS+ in target setting - patient survey(Phase III: Baseline and 9 months post intervention)
- Self-reported CRCS adherence(Phase II: Baseline, 3 months, and 9 months post randomization)
- EHR Paradata(Phase II: continuous)
- Psychosocial Constructs(Phase II: Baseline, 3 months, and 9 months post randomization)
- General and test-specific colorectal cancer screening barriers(Phase II: Baseline, 3 months, and 9 months post randomization)