Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 645
- 试验地点
- 23
- 主要终点
- Proportion of patients reporting at least one non-ideal or missing CVH topic
研究概览
简要总结
The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology practices, using a group-randomized trial design (6 intervention practices and 6 usual care practices). Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk reduction and health promotion activities compared to usual care.
详细描述
In this hybrid effectiveness-implementation group-randomized clinical trial, 6 intervention practices will receive an EHR-based cardiovascular health assessment tool (Automated Heart Health Assessment for Survivors: AH-HA) and 6 practices will serve as usual care (control) practices without access to the AH-HA tool. AH-HA renders a visual, interactive display of CVH risk factors, automatically populated from the EHR. This tool was first implemented in primary care and now incorporates EHR data on receipt of cancer treatments with cardiotoxic potential. Providers at each intervention site will be trained to use the tool during routine follow-up care with survivors. Eligible survivors with breast, prostate, colorectal, endometrial, or Hodgkin and non-Hodgkin lymphoma cancer (n=600) will provide baseline data before and immediately after seeing their oncology provider and complete 6-month and 1-year study follow-up visits. The study team will compare changes in outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from survivor self-reports and the EHR. The primary outcome is CVH discussions defined as the number of patient-reported discussions with their provider regarding up to seven non-ideal CVH conditions identified for that patient during oncology visits. Secondary outcomes include referrals to primary care and cardiology, provider efforts to manage CV risk, survivors' completed visits with primary care providers and cardiologists, and control of CVH factors and behaviors. Implementation metrics will be assessed using data from the EHR and semi-structured interviews with providers and administrators (n=24-30) at intervention clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •>= 6 months post-potentially curative cancer treatment for breast, prostate, colorectal, or endometrial cancers or Hodgkin and non-Hodgkin lymphomas. Ongoing hormonal therapies such as tamoxifen, aromatase inhibitors (with or without adjuvant CDK 4/6 inhibitors such as abemaciclib), or androgen deprivation are allowed.
- •Scheduled for a routine cancer-related follow-up care visit within the next 30 days with a provider who received training to use AH-HA.
- •Able and willing to complete a follow-up assessment in one year.
- •Survivors must have no evidence of disease at the time of last medical visit for all cancers, except non-melanoma skin disease.
- •Age >= 18 years.
- •Able to understand and willing to provide verbal informed consent.
排除标准
- •Survivors will be excluded if they have a history of cancer recurrence for any cancer other than non-melanoma skin disease.
- •Prostate patients on active surveillance will be excluded.
- •Survivor does not speak English or Spanish.
- •Survivors who are currently on another interventional protocol in which cardiovascular risk factors (e.g., blood pressure, smoking, diet, physical activity) are being addressed, as per patient self-report or research staff members' knowledge at the time of consent.
研究组 & 干预措施
Intervention - AH-HA tool
With assistance from the study team, the clinic will implement the AH-HA tool in the clinics' EPIC EHR. Providers at the intervention sites will be trained to use the tool during routine follow-up care with survivors. During a routine follow-up care appointment, the provider will use the AH-HA tool with enrolled patients.
干预措施: AH-HA Tool in the EPIC EHR (Other)
Usual Care
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
结局指标
主要结局
Proportion of patients reporting at least one non-ideal or missing CVH topic
时间窗: Baseline
Discussion of non-ideal cardiovascular health (CVH) factors (yes or no). CVH discussions will be defined as patient-reported discussions with their provider for any of the seven non-ideal CVH conditions identified for that patient. Conditions include CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical activity). Measured using survivor survey (discussions, diet, and primary care) and EHR for other CVH factors.
Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic
时间窗: Baseline
Discussion of non-ideal cardiovascular health (CVH) factors (yes or no). CVH discussions will be defined as patient-reported discussions with their provider for any of the seven non-ideal CVH conditions identified for that patient. Conditions include CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical activity). Measured using survivor survey (discussions, diet, and primary care) and EHR for other CVH factors.
次要结局
- CVH factors recorded in the past year(1 year)
- CVH behaviors recorded in the past year(1 year)
- Number of referrals to primary care and cardiology to manage CV risk(1 year)
- Completed visits with primary care providers and cardiology(1 year)
- Number of CVH-relevant labs and treatments to manage CV risk(1 year)
- Patient perception and knowledge of CV risks(Baseline, 6 months, 1 year)
- Proportion of survivors for whom AH-HA is utilized(1 year)
- Measure of tool acceptability with Tool Assessment(Baseline)
- Referrals to Primary Care to Manage CV Risk(Baseline)
- Referrals to Cardiology to Manage CV Risk(Baseline)
- Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test(Baseline)
- Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test(Baseline)
- Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test(Baseline)
- Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication(Baseline)
- Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication(Baseline)
- Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication(Baseline)
- Any Completed Visits With Primary Care Providers(1 year)
- Any Completed Visits With Cardiology Providers(1 year)
- Change in CVH Behaviors Recorded in the Past Year: Smoking Status(1 year)
- Change in CVH Behaviors Recorded in the Past Year: BMI(1 year)
- Change in CVH Behaviors Recorded in the Past Year: Physical Activity(1 year)
- Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score(1 year)
- Change in CVH Factors Recorded in the Past Year: Total Cholesterol(1 year)
- Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure(1 year)
- Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure(1 year)
- Change in CVH Factors Recorded in the Past Year: A1c(1 year)
- Change in CVH Factors Recorded in the Past Year: Glucose(1 year)
- Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease(Baseline)
- Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health(Baseline)
- Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year(Baseline)
- Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health(Baseline)
- Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health(Baseline)
- Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health(Baseline)
- Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health(Baseline)
- Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health(Baseline)
- Proportion of Survivors for Whom AH-HA is Utilized(Baseline)
- Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider(Baseline)
- Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score(Baseline)
- Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand(Baseline)
- Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health(Baseline)
- Measure of Tool Acceptability With Tool Assessment: I Would Like to Use This Tool to Talk About my Heart Health With my Oncology Provider at a Future Appointment(Baseline)