Trial Outcomes & Findings for Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for HF (NCT NCT03334188)

Last Updated: 2021-10-06

Results Overview

The investigators were interested in whether the patient engagement tool led to an increase in the optimization of HFrEF medications for patients. This was measured through medical record review of all medications and doses immediately preceding the cardiology clinic visit (enrollment) to 30 days after enrollment.

Recruitment status

COMPLETED

Study phase

Target enrollment

306 participants

Primary outcome timeframe

Enrollment, 1 month (30 days) after enrollment

Results posted on

2021-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Control Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their heart failure with a reduced ejection fraction (HFrEF) medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their heart failure with a reduced ejection fraction (HFrEF) medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Overall Study STARTED	153	153
Overall Study COMPLETED	145	145
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their heart failure with a reduced ejection fraction (HFrEF) medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their heart failure with a reduced ejection fraction (HFrEF) medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Overall Study Withdrawal by Subject	0	1
Overall Study Death	1	0
Overall Study Never had qualifying clinic visit	7	7

Baseline Characteristics

Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for HF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=145 Participants Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention n=145 Participants Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.	Total n=290 Participants Total of all reporting groups
Age, Customized Age	64 years n=5 Participants	66 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	104 Participants n=7 Participants	206 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=5 Participants	134 Participants n=7 Participants	270 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	120 Participants n=5 Participants	119 Participants n=7 Participants	239 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Employment Employed	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Employment Retired	59 Participants n=5 Participants	72 Participants n=7 Participants	131 Participants n=5 Participants
Employment Unemployed	39 Participants n=5 Participants	23 Participants n=7 Participants	62 Participants n=5 Participants
Employment Missing	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Insurance Medicare, Tricare	71 Participants n=5 Participants	73 Participants n=7 Participants	144 Participants n=5 Participants
Insurance Medicaid	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Insurance Private	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Insurance None	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Income Less than or equal to $20,000	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Income $20,001--$40,000	31 Participants n=5 Participants	17 Participants n=7 Participants	48 Participants n=5 Participants
Income $40,001--$60,000	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Income $60,001--$80,000	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Income Greater than $80,000	32 Participants n=5 Participants	44 Participants n=7 Participants	76 Participants n=5 Participants
Income Missing	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Single Relationship Status	59 Participants n=5 Participants	56 Participants n=7 Participants	115 Participants n=5 Participants
Can receive text messages	86 Participants n=5 Participants	77 Participants n=7 Participants	163 Participants n=5 Participants
Systolic blood pressure	110 mmHg n=5 Participants	112.5 mmHg n=7 Participants	111.3 mmHg n=5 Participants
Diastolic blood pressure	70 mmHg n=5 Participants	70 mmHg n=7 Participants	70 mmHg n=5 Participants
Pulse	74.5 bpm (beats per minute) n=5 Participants	72.5 bpm (beats per minute) n=7 Participants	73.5 bpm (beats per minute) n=5 Participants
left ventricular ejection fraction (LVEF)	32.5 percent n=5 Participants	32.5 percent n=7 Participants	32.5 percent n=5 Participants
brain natriuretic peptide (BNP)	266 pg/mL n=5 Participants	161.5 pg/mL n=7 Participants	213.8 pg/mL n=5 Participants
Serum creatinine	1.1 mg/dL n=5 Participants	1.0 mg/dL n=7 Participants	1.05 mg/dL n=5 Participants
Serum potassium	4.3 mmol/L n=5 Participants	4.2 mmol/L n=7 Participants	4.25 mmol/L n=5 Participants

PRIMARY outcome

Timeframe: Enrollment, 1 month (30 days) after enrollment

Outcome measures

Outcome measures
Measure	Control n=145 Participants Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention n=145 Participants Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT)	29.7 percentage of participants	49.0 percentage of participants

SECONDARY outcome

Timeframe: 1 month after delivery of intervention materials.

Population: Of the 145 intervention patients that were sent the survey, 126 responded to the survey. Only intervention participants were analyzed for this outcome, since Control participants received usual care.

The investigators were interested in whether the patient engagement tool (a 3-minute video and 1-page checklist-delivered electronically 1 week prior, 3 days prior and 24 hours prior to the enrollment cardiology clinic visit) led to an increase in patient sense of engagement around their HFrEF medication prescribing, prompting patients to begin a dialogue with their clinician about their medication plan. This was assessed among the Intervention group by comparing answers from a self-reported survey at 1 month after delivery of intervention materials. Participants were sent the survey and asked if they received and reviewed the intervention materials. Survey measures were included as well as a series of questions asking about how and when medications were discussed during clinical interactions.

Outcome measures

Outcome measures
Measure	Control n=126 Participants Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Self-Reported Patient Engagement Around HFrEF Medications Reported receiving the video	81 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Reported reviewing the video	73 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Found the video helpful in understanding their medical plan	53 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Found the video helpful in discussing their medicines with their doctor	51 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Reported receiving the checklist	83 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Reported reviewing the checklist	74 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Found the checklist helpful in understanding their medical plan	56 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Found the checklist helpful in discussing their medicines with their doctor	48 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Brought the checklist to their appointment	61 Participants	—
Self-Reported Patient Engagement Around HFrEF Medications Talked about checklist with doctor at their appointment	52 Participants	—

SECONDARY outcome

Timeframe: Enrollment, 1 month (30 days) after enrollment

Initiation or intensification of key heart failure medications was determined by medical chart review conducted at immediately following the cardiology clinic appointment (enrollment) and for the clinic visit closest to 1 month (30 days) after the enrollment visit. Raw numbers of participants were analyzed.

Outcome measures

Outcome measures
Measure	Control n=145 Participants Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention n=145 Participants Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Intensification occurring during cardiology clinic visit (day 1)	42 Participants	61 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Any intensification in HFrEF medication, including GDMT, loop diuretic, or digoxin	45 Participants	73 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Key heart failure medication added	10 Participants	17 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Beta blocker added	2 Participants	0 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ACE-I added	1 Participants	4 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ARB added	4 Participants	2 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ARNI added	0 Participants	0 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Loop diuretic added	0 Participants	0 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Aldosterone antagonist added	3 Participants	5 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Ivabradine added	0 Participants	1 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Hydralazine added	1 Participants	1 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Isosorbide added	1 Participants	2 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Digoxin added	0 Participants	0 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ACE-I or ARB replaced with ARNI	3 Participants	4 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Key heart failure medication up titrated	33 Participants	58 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Beta blocker up titrated	16 Participants	32 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ACE-I up titrated	4 Participants	7 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ARB up titrated	7 Participants	7 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications ARNI up titrated	5 Participants	6 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Loop diuretic up titrated	1 Participants	0 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Aldosterone antagonist up titrated	3 Participants	8 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Ivabradine up titrated	0 Participants	0 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Hydralazine up titrated	0 Participants	2 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Isosorbide up titrated	0 Participants	1 Participants
Number of Participants With Initiation/Intensification of Key Heart Failure Medications Digoxin up titrated	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Enrollment, 1 month (30 days) after enrollment

Guideline-directed medical therapy (GDMT) intensifications per patient from the pre-clinic visit (enrollment) to 1-month (30 days) after enrollment. This was measured by medical chart reviewing of the pre-clinic visit appointment and the closest clinic appointment preceding the 30 day mark after enrollment. Key: guideline directed medical therapy (GDMT); evidence-based beta blocker (EVBB); angiotensin converting enzyme inhibitors (ACE-I); angiotensin receptor blockers (ARB); angiotensin receptor neprilysin inhibitors (ARNI); mineralocorticoid receptor agonists (MRA); hydralazine/isosorbide dinitrate (H/ISDN); Ivabradine (Iva)

Outcome measures

Outcome measures
Measure	Control n=145 Participants Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention n=145 Participants Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient # of GDMT intensifications (initiation/dose increase EVBB, ACEI, ARB, ARNI, MRA, H/ISDN, or Iva)	0.36 intensifications Standard Deviation 0.61	0.61 intensifications Standard Deviation 0.73
Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient # of all intensifications (including GDMT plus initiation or uptitration of loop diuretic or digoxin	0.38 intensifications Standard Deviation 0.62	0.63 intensifications Standard Deviation 0.73

SECONDARY outcome

Timeframe: Enrollment, 1-month (30 days) after Enrollment

Unplanned hospitalizations or emergency department visits without hospitalization from the cardiology clinic visit (enrollment) to 1-month (30 days) after enrollment. Hospitalization and emergency department visits were obtained via medical chart review and were analyzed as yes/no per patient.

Outcome measures

Outcome measures
Measure	Control n=145 Participants Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'. No Intervention--Usual Care: Control for intervention--patient receives care as usual from provider to contrast against intervention arm.	Intervention n=145 Participants Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.' Patient engagement materials: The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
Safety Outcomes Unplanned hospitalization at 30 days	4 participants	6 participants
Safety Outcomes Emergency department visit without hospitalization at 30 days	5 participants	9 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Larry Allen, Professor of Medicine

University of Colorado | School of Medicine | ACCORDS

Phone: 303-724-4713

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place