Breast Neoplasm, Colorectal Neoplasms, Endometrial Neoplasms, Hodgkin Disease, Non Hodgkin Lymphoma, Prostatic Neoplasm
Conditions
Keywords
Cardiovascular risk, Cardiovascular disease, Cancer, Survivor, Health Behaviors, Oncology Providers, EHR, Informatics
Brief summary
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.
Detailed description
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.
Interventions
OTHERAH-HA Tool in the EPIC EHR
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Washington University School of Medicine
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referrals to Primary Care to Manage CV Risk | Baseline | Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit. |
| Referrals to Cardiology to Manage CV Risk | Baseline | Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit. |
| Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test | Baseline | Medical chart abstraction. |
| Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test | Baseline | Medical chart abstraction. |
| Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test | Baseline | Medical chart abstraction. |
| Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication | Baseline | Medical chart abstraction. |
| Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication | Baseline | Medical chart abstraction. |
| Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication | Baseline | Medical chart abstraction. |
| Any Completed Visits With Primary Care Providers | 1 year | Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit |
| Any Completed Visits With Cardiology Providers | 1 year | Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit |
| Change in CVH Behaviors Recorded in the Past Year: Smoking Status | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Proportion of participants who were non-smoking at 1-year, of those who were smoking at baseline. |
| Change in CVH Behaviors Recorded in the Past Year: BMI | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in BMI from baseline to 1-year. |
| Change in CVH Behaviors Recorded in the Past Year: Physical Activity | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in total minutes of physical activity per week from baseline to 1-year. |
| Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in healthy diet score from baseline to 1-year. Healthy diet score is calculated from the sum of 5 diet questions (range: 0-5) with higher scores indicating a healthier diet. |
| Change in CVH Factors Recorded in the Past Year: Total Cholesterol | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in total cholesterol from baseline to 1-year. |
| Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in systolic blood pressure l from baseline to 1-year. |
| Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in diastolic blood pressure l from baseline to 1-year. |
| Change in CVH Factors Recorded in the Past Year: A1c | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in A1c from baseline to 1-year. |
| Change in CVH Factors Recorded in the Past Year: Glucose | 1 year | Medical chart abstraction; Patient survey as secondary, verification source. Change in glucose from baseline to 1-year. |
| Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease | Baseline | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline. |
| Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health | Baseline | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit 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 | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline. |
| Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health | Baseline | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline. |
| Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health | Baseline | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline. |
| Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health | Baseline | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit 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 | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline. |
| Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health | Baseline | Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline. |
| Proportion of Survivors for Whom AH-HA is Utilized | Baseline | We will capture the number of eligible patient visits during which the AH-HA tool was used in intervention clinics and the total number of eligible visits to calculate the proportion of patients where AH-HA was utilized. |
| Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider | Baseline | In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree. |
| Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score | Baseline | In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree. |
| Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand | Baseline | In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree. |
| Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health | Baseline | In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree. |
| 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 | In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKathryn Weaver, MD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 286 Participants |
| Age, Categorical Between 18 and 65 years | 164 Participants |
| Cancer Type Breast | 274 Participants |
| Cancer Type Endometrial | 54 Participants |
| Cancer Type Other/Multiple | 40 Participants |
| Cancer Type Uknown | 1 Participants |
| Cardiovascular Comorbidities Atherosclerotic Vascular Disease (ASCVD) | 73 Participants |
| Cardiovascular Comorbidities Diabetes | 52 Participants |
| Cardiovascular Comorbidities High Cholesterol | 172 Participants |
| Cardiovascular Comorbidities Hypertension/High Blood Pressure | 128 Participants |
| Cardiovascular Comorbidities Obesity | 206 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 50 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other/More than one race | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 308 Participants |
| Receipt of Anthracyclines | 151 Participants |
| Receipt of Any Cancer Treatment | 315 Participants |
| Receipt of Chemotherapy | 335 Participants |
| Receipt of Hormone Therapy/Aromatase Inhibitors | 429 Participants |
| Receipt of Monoclonal Antibodies | 86 Participants |
| Receipt of Radiation | 439 Participants |
| Rural Residence | 113 Participants |
| Sex: Female, Male Female | 329 Participants |
| Sex: Female, Male Male | 8 Participants |
| Time Since Cancer Diagnosis | 4.82 Years STANDARD_DEVIATION 3.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 296 | 2 / 349 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed