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Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)

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ClinicalTrials.gov Identifier: NCT03935282
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Washington University School of Medicine
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
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 : May 21, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Number of CVH-relevant labs and treatments to manage CV risk [ Time Frame: 1 year ]
    Medical chart abstraction.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, 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.
  • Ability to understand and the willingness to sign a written informed consent document.

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.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Washington University School of Medicine
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Kathryn Weaver, MD Wake Forest University Health Sciences

Publications:
Hassoon A, Appel L, Maruthur N and Yeh H-C. Abstract 15582: Cardiovascular Risk Factors in Breast Cancer Survivors: Analysis of NHANES 1999-2012. Circulation. 2015;132:A15582-A15582.
IOM. Cancer Survivorship Care Planning. 2005.
From Cancer Patient to Cancer Survivor: Lost in Transition: The National Academies Press; 2005.
Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis: The National Academies Press; 2013.
Pearlstein K. Prevalence of cardiovascular disease (CVD) risk factors and preventive care among U.S. cancer survivors. Paper presented at: American Society of Clinical Oncology Annual Meeting; 2013; Chicago, IL.
HIMSS. United States EMR Adoption Model. EMR Adoption Model. 2012.
Improving Cancer-Related Outcomes with Connected Health: A Report to the President of the United States from the President's Cancer Panel. 2016.
Howlader N, Noone A, Krapcho M, Garshell J, Miller D, Altekruse S, Kosary C, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis D, Chen H, Feuer E and Cronin K. SEER Cancer Statistics Review, 1975-2011. SEER. 2014.
RE-AIM. Reach Effectiveness Adoption Implementation Maintenance. 2017;2017.
Foraker R, Kelley M, Wilkister T, Lin E-J and Weaver K. Oncologists' perceptions of the usability of SPHERE: an electronic health record applicaton based on Life's Simple 7. American Heart Association. 2016;133:AP075.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03935282     History of Changes
Other Study ID Numbers: IRB00056774
NCI-2019-01362 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Cardiovascular risk
Cardiovascular disease
Cancer
Survivor
Health Behaviors
Oncology Providers
EHR
Informatics

Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Endometrial Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Breast Diseases
Skin Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Diseases, Male