Testing the Impact of the MOHR Follow-up Support
Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition
研究概览
地位
详细说明
In previous pilot studies was found that patients in clinics randomized to the MOHR intervention vs. control significantly improved physical activity (p < 0.001) and diet risk behaviors (p < 0.001), as well as other risk factors. However, two gaps were identified. First, clinic partners voiced a need for a more flexible menu of delivery options to feasibly adopt and sustain the intervention. Second, to achieve sustained behavior change, particularly for those with unmet social needs, clinics need to provide structured follow-up. Structured follow-up bundles are part of the ERIC strategy of "enhance uptake and adherence (among patients)" and "technical assistance." In other work, additional reminders and resources improved outcomes of goal-setting interventions in general and among those with unmet social needs, so the study team operationalized these to be delivered either electronically (Reminder and Resources (R2) Message) or by a person (R2 Navigation). To fill these two gaps, we engaged with a subset of both UCHealth and rural primary care clinics and patient advisors to co-develop a menu of delivery options for the MOHR intervention and also a menu of options for the R2 Message and R2 Navigation strategy bundles.
In a randomized comparative effectiveness-implementation trial the study team will enroll 1,000 adult patients with two or more cancer risks (including both insufficient physical activity and fruit/vegetable intake). The study team will evaluate the outcomes of R2 Message and R2 Navigation alone or in combination. Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) improvement in practice value outcomes, including patient experience ratings.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Principal Investigator
- 电话号码：(303) 724-2268
- 邮箱：amy.huebschmann@cuanschutz.edu
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- 招聘中
- University Of Colorado Hospital
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接触：
- Rebekah Gomes
- 电话号码：303-724-3115
- 邮箱：rebekah.gomes@cuanschutz.edu
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首席研究员：
- Amy Huebschmann
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Denver、Colorado、美国、80206
- 招聘中
- UCHealth Cherry Creek Medical Center
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接触：
- Rebekah Gomes
- 电话号码：303-724-3115
- 邮箱：rebekah.gomes@cuanschutz.edu
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首席研究员：
- Amy Huebschmann
-
Denver、Colorado、美国、80045
- 招聘中
- UCHealth Women's Integrated Services in Health (WISH)
-
接触：
- Rebekah Gomes
- 电话号码：303-724-3115
- 邮箱：rebekah.gomes@cuanschutz.edu
-
Denver、Colorado、美国、80230
- 招聘中
- UCHealth Internal Medical Clinic - Lowry
-
接触：
- Rebekah Gomes
- 电话号码：303-724-3115
- 邮箱：rebekah.gomes@cuanschutz.edu
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首席研究员：
- Amy Huebschmann
-
Lone Tree、Colorado、美国、80124
- 招聘中
- UCHealth Lone Tree Medical Center
-
接触：
- Rebekah Gomes
- 电话号码：303-724-3115
- 邮箱：rebekah.gomes@cuanschutz.edu
-
首席研究员：
- Amy Huebschmann
-
Westminster、Colorado、美国、80021
- 招聘中
- UCHealth Family Medicine - Westminster
-
接触：
- Rebekah Gomes
- 电话号码：303-724-3115
- 邮箱：rebekah.gomes@cuanschutz.edu
-
首席研究员：
- Amy Huebschmann
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults, aged 18 years and older.
- Completion of the MOHR health risk assessment and goal-setting tool
- Score in the "at-risk" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit/vegetables
- Patient at one of the participating clinics
Exclusion Criteria:
- Incomplete or no MOHR assessment
- Language preference/proficiency other than English or Spanish
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Control Arm
Standardized version of usual care
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Regular (standard) care provided by healthcare provider team
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实验性的：R2 Message Only
Reminder and Resources Messages sent to patient
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Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using messages sent to patients.
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实验性的：R2 Navigation only
Reminder and Resources provided to patient via health navigator
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Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using health navigators calling the patients.
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实验性的：R2 Message + R2 Navigation
Both reminder and resources messages and navigation provided to the patient
|
Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using messages sent to patients.
Patients will be provided reminders and resources using health navigators calling the patients.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of MOHR risk factors
大体时间：From enrollment to the follow-up survey timepoint at 2 months.
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Primary effectiveness outcome measured on scale from -6 to +6 as change of the number of risk factors improved.
MOHR questions are organized into 6 risk areas: 1) intake of fruits and vegetables; 2) high sugar beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep.
Each risk factor is evaluated as low risk, medium risk, or high risk.
Level of improvement in risk factors outcome will be a count score from -6 to 6 (any improvement or decrement in level of risk in each factor will count as 1 or -1).
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From enrollment to the follow-up survey timepoint at 2 months.
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REACH - specifically representative engagement
大体时间：From enrollment to the follow-up survey timepoint at 6 months.
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Primary implementation outcome.
Representative engagement: Engagement during the follow-up period involves interactions over time of the participant with either or both a navigator or text messages .
Engagement will be assessed percent of navigator calls completed (maximum of 12 over 6 months) and percent of text messages successfully sent (maximum of 60 over 6 months).
To assess whether engagement is representative our primary assessments will be if there is differential engagement across conditions (e.g., an interaction effect) based on 1) number of baseline social needs, 2) Latine vs. non Latine ethnicity or 3) digital literacy.
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From enrollment to the follow-up survey timepoint at 6 months.
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Patient experience
大体时间：From enrollment to the follow up survey time point at 6 months.
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Primary practice value outcome measured by change in mean score on Patient Assessment of Quality-of-Care subscales of goal setting/tailoring and follow-up/coordination (PACIC).
Scale ranges from almost never (indicating the worst patient experience) to almost always (indicating the best patient experience).
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From enrollment to the follow up survey time point at 6 months.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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