Trial Outcomes & Findings for Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (NCT NCT03935282)

NCT ID: NCT03935282

Last Updated: 2026-04-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

645 participants

Primary outcome timeframe

Baseline

Results posted on

2026-04-15

Participant Flow

Unit of analysis: Practices

Participant milestones

Participant milestones
Measure
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. 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.
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.
Pre-Visit Baseline
STARTED
296 4
349 5
Pre-Visit Baseline
COMPLETED
294 4
346 5
Pre-Visit Baseline
NOT COMPLETED
2 0
3 0
Post-Visit Baseline
STARTED
294 4
346 5
Post-Visit Baseline
COMPLETED
292 4
343 5
Post-Visit Baseline
NOT COMPLETED
2 0
3 0
6-Months Post-Visit
STARTED
292 4
343 5
6-Months Post-Visit
COMPLETED
274 4
336 5
6-Months Post-Visit
NOT COMPLETED
18 0
7 0
12-Months Post-Visit
STARTED
274 4
336 5
12-Months Post-Visit
COMPLETED
259 4
326 5
12-Months Post-Visit
NOT COMPLETED
15 0
10 0

Reasons for withdrawal

Reasons for withdrawal
Measure
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. 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.
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.
Pre-Visit Baseline
Withdrawal by Subject
2
2
Pre-Visit Baseline
Lost to Follow-up
0
1
Post-Visit Baseline
Withdrawal by Subject
1
2
Post-Visit Baseline
Physician Decision
1
0
Post-Visit Baseline
Lost to Follow-up
0
1
6-Months Post-Visit
Lost to Follow-up
13
5
6-Months Post-Visit
Death
1
0
6-Months Post-Visit
Withdrawal by Subject
4
2
12-Months Post-Visit
Lost to Follow-up
15
7
12-Months Post-Visit
Death
0
2
12-Months Post-Visit
Withdrawal by Subject
0
1

Baseline Characteristics

Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention - AH-HA Tool
n=296 Participants
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. 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.
Usual Care
n=349 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Total
n=645 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=193 Participants
0 Participants
n=193 Participants
0 Participants
n=386 Participants
Age, Categorical
Between 18 and 65 years
164 Participants
n=193 Participants
195 Participants
n=193 Participants
359 Participants
n=386 Participants
Age, Categorical
>=65 years
132 Participants
n=193 Participants
154 Participants
n=193 Participants
286 Participants
n=386 Participants
Sex: Female, Male
Female
288 Participants
n=193 Participants
329 Participants
n=193 Participants
617 Participants
n=386 Participants
Sex: Female, Male
Male
8 Participants
n=193 Participants
20 Participants
n=193 Participants
28 Participants
n=386 Participants
Race/Ethnicity, Customized
Race/Ethnicity · White
233 Participants
n=193 Participants
308 Participants
n=193 Participants
541 Participants
n=386 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
35 Participants
n=193 Participants
15 Participants
n=193 Participants
50 Participants
n=386 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
14 Participants
n=193 Participants
10 Participants
n=193 Participants
24 Participants
n=386 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Other/More than one race
14 Participants
n=193 Participants
16 Participants
n=193 Participants
30 Participants
n=386 Participants
Cancer Type
Breast
274 Participants
n=193 Participants
255 Participants
n=193 Participants
529 Participants
n=386 Participants
Cancer Type
Endometrial
1 Participants
n=193 Participants
53 Participants
n=193 Participants
54 Participants
n=386 Participants
Cancer Type
Other/Multiple
20 Participants
n=193 Participants
40 Participants
n=193 Participants
60 Participants
n=386 Participants
Cancer Type
Uknown
1 Participants
n=193 Participants
1 Participants
n=193 Participants
2 Participants
n=386 Participants
Rural Residence
57 Participants
n=193 Participants
56 Participants
n=193 Participants
113 Participants
n=386 Participants
Time Since Cancer Diagnosis
4.57 Years
STANDARD_DEVIATION 3.87 • n=193 Participants
4.82 Years
STANDARD_DEVIATION 3.83 • n=193 Participants
4.70 Years
STANDARD_DEVIATION 3.85 • n=386 Participants
Receipt of Any Cancer Treatment
285 Participants
n=193 Participants
315 Participants
n=193 Participants
600 Participants
n=386 Participants
Receipt of Radiation
194 Participants
n=193 Participants
245 Participants
n=193 Participants
439 Participants
n=386 Participants
Receipt of Chemotherapy
109 Participants
n=193 Participants
226 Participants
n=193 Participants
335 Participants
n=386 Participants
Receipt of Anthracyclines
57 Participants
n=193 Participants
94 Participants
n=193 Participants
151 Participants
n=386 Participants
Receipt of Hormone Therapy/Aromatase Inhibitors
233 Participants
n=193 Participants
196 Participants
n=193 Participants
429 Participants
n=386 Participants
Receipt of Monoclonal Antibodies
35 Participants
n=193 Participants
51 Participants
n=193 Participants
86 Participants
n=386 Participants
Cardiovascular Comorbidities
Hypertension/High Blood Pressure
128 Participants
n=193 Participants
176 Participants
n=193 Participants
304 Participants
n=386 Participants
Cardiovascular Comorbidities
High Cholesterol
124 Participants
n=193 Participants
172 Participants
n=193 Participants
296 Participants
n=386 Participants
Cardiovascular Comorbidities
Obesity
55 Participants
n=193 Participants
151 Participants
n=193 Participants
206 Participants
n=386 Participants
Cardiovascular Comorbidities
Diabetes
52 Participants
n=193 Participants
68 Participants
n=193 Participants
120 Participants
n=386 Participants
Cardiovascular Comorbidities
Atherosclerotic Vascular Disease (ASCVD)
22 Participants
n=193 Participants
73 Participants
n=193 Participants
95 Participants
n=386 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
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 Discussion of at Least One Non-ideal or Missing CVH Topic
96.2 Percentage of participants
Interval 93.5 to 97.8
52.2 Percentage of participants
Interval 45.6 to 58.8

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Referrals to Primary Care to Manage CV Risk
28.7 percentage of participants
Interval 15.7 to 46.7
24.8 percentage of participants
Interval 14.2 to 39.7

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Referrals to Cardiology to Manage CV Risk
2.9 percentage of participants
Interval 0.8 to 10.0
2.9 percentage of participants
Interval 1.4 to 5.8

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test
25 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test
19 Participants
49 Participants

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test
22 Participants
1 Participants

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication
3 Participants
3 Participants

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Baseline

Medical chart abstraction.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication
3 Participants
3 Participants

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Any Completed Visits With Primary Care Providers
63.2 percentage of participants
Interval 46.9 to 77.0
74.5 percentage of participants
Interval 62.2 to 83.8

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Any Completed Visits With Cardiology Providers
5.3 percentage of participants
Interval 2.6 to 10.5
16.2 percentage of participants
Interval 12.0 to 21.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Behaviors Recorded in the Past Year: Smoking Status
47.1 percentage of participants
Interval 18.1 to 78.1
13.1 percentage of participants
Interval 1.8 to 55.8

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction; Patient survey as secondary, verification source. Change in BMI from baseline to 1-year.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Behaviors Recorded in the Past Year: BMI
-0.98 BMI (kg/m^2)
Interval -3.01 to 1.05
0.97 BMI (kg/m^2)
Interval -0.56 to 2.49

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Behaviors Recorded in the Past Year: Physical Activity
-32.8 minutes/week
Interval -151.7 to 86.0
23.9 minutes/week
Interval -66.1 to 113.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score
0.5 diet score
Interval 0.2 to 0.8
0.4 diet score
Interval 0.1 to 0.6

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction; Patient survey as secondary, verification source. Change in total cholesterol from baseline to 1-year.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Factors Recorded in the Past Year: Total Cholesterol
-1.3 total cholesterol (mg/dL)
Interval -8.6 to 6.0
-0.4 total cholesterol (mg/dL)
Interval -6.2 to 5.4

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction; Patient survey as secondary, verification source. Change in systolic blood pressure l from baseline to 1-year.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure
0.1 SBP (mmHg)
Interval -2.5 to 2.8
-0.2 SBP (mmHg)
Interval -2.3 to 1.8

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction; Patient survey as secondary, verification source. Change in diastolic blood pressure l from baseline to 1-year.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure
-0.8 DBP (mmHg)
Interval -2.3 to 0.8
-0.4 DBP (mmHg)
Interval -1.6 to 0.8

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction; Patient survey as secondary, verification source. Change in A1c from baseline to 1-year.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Factors Recorded in the Past Year: A1c
-0.2 A1c (%)
Interval -0.7 to 0.3
0.3 A1c (%)
Interval -0.1 to 0.6

SECONDARY outcome

Timeframe: 1 year

Medical chart abstraction; Patient survey as secondary, verification source. Change in glucose from baseline to 1-year.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=274 Participants
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. 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.
Usual Care
n=336 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Change in CVH Factors Recorded in the Past Year: Glucose
6.3 glucose (mg/dL)
Interval -4.1 to 16.7
4.4 glucose (mg/dL)
Interval -2.3 to 11.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease
61.3 percentage of participants
Interval 40.6 to 78.6
42.0 percentage of participants
Interval 27.8 to 57.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health
80.8 percentage of participants
Interval 65.3 to 90.4
54.9 percentage of participants
Interval 36.3 to 72.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year
79.2 percentage of participants
Interval 48.8 to 93.8
49.5 percentage of participants
Interval 33.2 to 65.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health
33.4 percentage of participants
Interval 13.4 to 61.9
45.0 percentage of participants
Interval 22.2 to 70.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health
57.1 percentage of participants
Interval 39.7 to 72.9
31.8 percentage of participants
Interval 21.6 to 44.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health
61.6 percentage of participants
Interval 42.0 to 78.0
24.7 percentage of participants
Interval 16.3 to 35.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health
63.3 percentage of participants
Interval 51.5 to 73.7
67.9 percentage of participants
Interval 50.2 to 81.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=294 Participants
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. 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.
Usual Care
n=346 Participants
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health
63.4 percentage of participants
Interval 40.6 to 81.5
23.7 percentage of participants
Interval 16.0 to 33.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=296 Participants
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. 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.
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 Survivors for Whom AH-HA is Utilized
245 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Of the 294 participants in the intervention arm, 245 reported using the AH-HA tool with their provider at baseline visit.

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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=245 Participants
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. 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.
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.
Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider
231 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Of the 294 participants in the intervention arm, 245 reported using the AH-HA tool with their provider at baseline visit.

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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=245 Participants
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. 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.
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.
Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score
229 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Of the 294 participants in the intervention arm, 245 reported using the AH-HA tool with their provider at baseline visit.

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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=245 Participants
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. 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.
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.
Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand
228 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Of the 294 participants in the intervention arm, 245 reported using the AH-HA tool with their provider at baseline visit.

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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=245 Participants
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. 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.
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.
Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health
204 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Of the 294 participants in the intervention arm, 245 reported using the AH-HA tool with their provider at baseline visit.

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.

Outcome measures

Outcome measures
Measure
Intervention - AH-HA Tool
n=245 Participants
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. 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.
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.
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
208 Participants

Adverse Events

Intervention - AH-HA Tool

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emily Dressler

NCORP

Phone: 336-716-0891

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place