Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03935282|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : March 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Prostatic Neoplasm Colorectal Neoplasms Endometrial Neoplasms Hodgkin Disease Non Hodgkin Lymphoma||Other: AH-HA Tool in the EPIC EHR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||645 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||March 7, 2024|
|Estimated Study Completion Date :||March 7, 2024|
Experimental: 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.
Other: AH-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.
No Intervention: 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.
- Proportion of patients reporting at least one non-ideal or missing CVH topic [ Time Frame: 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.
- Number of referrals to primary care and cardiology to manage CV risk [ Time Frame: 1 year ]Medical chart abstraction of referrals and communication with providers regarding CVH at each survivor visit.
- Number of CVH-relevant labs and treatments to manage CV risk [ Time Frame: 1 year ]Medical chart abstraction.
- Completed visits with primary care providers and cardiology [ Time Frame: 1 year ]Medical chart abstraction of referrals and communication with providers regarding CVH at each survivor visit.
- CVH behaviors recorded in the past year [ Time Frame: 1 year ]Medical chart abstraction; Patient survey as secondary, verification source. Measured using smoking status, BMI, physical activity, and healthy diet.
- CVH factors recorded in the past year [ Time Frame: 1 year ]Medical chart abstraction; Patient survey as secondary, verification source. Measured using total cholesterol, blood pressure, and fasting plasma glucose/Alc.
- Patient perception and knowledge of CV risks [ Time Frame: Baseline, 6 months, 1 year ]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.Minimum score is 0, maximum score is 3 and answer is the total number of questions where a patient responded agree or strongly agree.
- Proportion of survivors for whom AH-HA is utilized [ Time Frame: 1 year ]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 [ Time Frame: 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. Patients will respond to 5 questions on a scale from strongly agree to strongly disagree.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- >= 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935282
|United States, Arkansas|
|Mercy Hospital Fort Smith|
|Fort Smith, Arkansas, United States, 72903|
|United States, Iowa|
|Oncology Associates at Mercy Medical Center|
|Cedar Rapids, Iowa, United States, 52403|
|United States, Missouri|
|Saint Louis Cancer and Breast Institute-Ballwin|
|Ballwin, Missouri, United States, 63011|
|Mercy Hospital Saint Louis|
|Saint Louis, Missouri, United States, 63141|
|Mercy Hospital Springfield|
|Springfield, Missouri, United States, 65804|
|United States, Oklahoma|
|Mercy Hospital Oklahoma City|
|Oklahoma City, Oklahoma, United States, 73120|
|United States, Pennsylvania|
|Community Medical Center|
|Scranton, Pennsylvania, United States, 18510|
|Geisinger Wyoming Valley/Henry Cancer Center|
|Wilkes-Barre, Pennsylvania, United States, 18711|
|United States, Tennessee|
|Baptist Memorial Hospital and Cancer Center-Memphis|
|Memphis, Tennessee, United States, 38120|
|Baptist Memorial Hospital for Women|
|Memphis, Tennessee, United States, 38120|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|United States, Wisconsin|
|ThedaCare Regional Cancer Center|
|Appleton, Wisconsin, United States, 54911|
|Principal Investigator:||Kathryn Weaver, MD||Wake Forest University Health Sciences|
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
NCI-2019-01362 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R01CA226078 ( U.S. NIH Grant/Contract )
NCI-2019-01362 ( Registry Identifier: NCI CTRP )
|First Posted:||May 2, 2019 Key Record Dates|
|Last Update Posted:||March 3, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.|
|Time Frame:||6 months after publication for a 2 year duration.|
|Access Criteria:||upon request to NCORP@wakehealth.edu|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Histologic Type
Immune System Diseases
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Male Urogenital Diseases