An interventional study of Patient engagement materials and No Intervention--Usual Care in Patient Engagement, Medication Optimization and Heart Failure With Reduced Ejection Fraction, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other
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Among 154 studies in Patient Participation with a site in United States — 27 open to participants now, 31 under way, none of them phase 3. Patient Participation · United States.
Among the 154 studies in Patient Participation with a site in United States, this one is the 42nd largest by enrollment of the 139 interventional ones that give a count, is one of 6 that started in 2018, is one of 132 with no phase, and was the 43rd registered.
409 studies on the registry are indexed under Patient Participation; 100 are open to participants now.
Browse Patient Participation studies →27 of the 154 studies in Patient Participation with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 18+ · Women only · Healthy volunteers
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
University of Nebraska · Sites in United States
Ages 15–18
University of Washington · Sites in United States
Ages 14+ · Healthy volunteers
Columbia University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 48 Patient Participation studies recruiting now, 32 (67%) set no upper age limit and 9 (19%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 306 is above the median of 128 across 322 interventional studies indexed under Patient Participation.
Median enrollment 130 across the 139 interventional studies, 257 across the 15 observational. Of the 114 that completed or were terminated, 42 (37%) have results posted.
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10 of 154 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Patient Participation — fewer than ten, so there is no comparison to draw.
13 of the studies in Patient Participation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
| NCT06246409University of FloridaModernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy | 2026-12 |
| NCT07489105Auburn UniversityForge AHEAD: Feasibility of Yoga to Improve Cognitive Function | 2026-12-31 |
| NCT06581484University of California, San FranciscoImproving Congenital Heart Disease Care | 2026-12-31 |
| NCT06358261Johns Hopkins UniversityStudy of a Diabetes Prevention Patient Activation Clinical Decision Support Tool | 2027-01-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 154 studies in Patient Participation with a site in United States, from their registry updates:
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The EPIC-HF study will test the effectiveness of a patient empowerment and activation for optimization of Heart Failure with reduced Ejection Fraction (HFrEF) medication plans. Three main regional centers in the University of Colorado Health (UCHealth) system will participate in a two-arm, randomized study design. In this design, each site participates in both control and intervention, with members of the sites eligible patient population randomly enrolled in either the intervention or the control arm. All eligible patients who agree to participate in the study will complete the Baseline Survey, the Follow-Up Survey, and will have information collected from their medical record at baseline, 1 month after the first clinic appointment post-enrollment, and 1 year after enrollment. Enrollment will take place at three UCHealth locations: UCHealth University of Colorado Hospital (Metro), UCHealth Medical Center of the Rockies and UCHealth Poudre Valley Hospital (North), and UCHealth Memorial Central and Memorial North (South). Study personnel at the North and South sites will carry out enrollment and Baseline Surveys with patients for those locations; all other study procedures will be conducted by study personnel at the University of Colorado (UC) School of Medicine (SOM) (UCSOM) at UCHealth University of Colorado School of Medicine.
Patients enrolled in the intervention arm will receive, by email and/or text, a link to 1) a short patient engagement video around HFrEF medications, and 2) a link to an online portable document format (PDF) of a HFrEF medication checklist. Patients in the intervention arm will receive these materials after enrollment and one week prior to their next scheduled clinic appointment. The materials will be delivered in a second communication, three days after the first, via text, as well as a third communication on the day of the clinic appointment. Patients enrolled in the control arm will not receive any materials at any point of time and will receive their usual care.
For both arms, medication changes in patient medical records will be assessed before and after clinic visits to measure the effectiveness of the intervention on aim 1; surveys will be compared before and after clinic visits to determine the effectiveness of the intervention on aim 2.
Multiple medications improve left ventricular remodeling, quality of life, and survival in patients with heart failure with reduced ejection fraction (HFrEF). Unfortunately, the real-world use of HFrEF medications is suboptimal, particularly for more recently approved agents such as aldosterone antagonists. The introduction of sacubitril/valsartan and ivabradine add to already complex HFrEF treatment regimens. Without novel mechanisms to improve medication use, the benefits of advances in HF treatment will be largely unrealized.
Efforts to optimize HFrEF medication delivery have focused primarily on 1) provider decision support around prescribing and 2) patient education around adherence. An important gap is the failure to empower patients to engage more directly in HFrEF prescribing efforts. Patients have a direct stake in making sure they are getting efficacious treatments, want to be involved in decisions about their treatments, and if engaged are more likely to adhere to them. Direct-to-consumer marketing and proliferation of shared decision making reflect a culture where patients are increasingly involved in medication prescribing.
Within this context, the American Heart Association (AHA) has funded four centers across the United States to examine ways in which heart failure treatment and prevention may be optimized. The University of Colorado, Denver is one of these sites; The Development and Trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure Tool (EPIC-HF) is the population-focused arm of study. Inspired by the gap in HFrEF medication optimization, this study aims to develop a patient-centered intervention in order to 1) activate and engage patients with HFrEF in their prescribing regimen, 2) empower them to initiate discussions with their provider about ways in which their medication plan could be improved, which will result in 3) a superior HFrEF medication plan. The investigators modeled this tool with the previous success of flipped classrooms and patient empowerment initiatives in mind. The intervention was iteratively developed with the input of both clinician and patient stakeholders, and is innovative in its emphasis on patient self-actualization and role as an equal with their healthcare provider in the discussion around medication prescribing. This study applies the intervention in a two-arm, randomized controlled trial across three sites (UCHealth metro, Memorial, and Medical Center of the Rockies) in the UCHealth medical system.
Aim 1: Assess the effectiveness of the EPIC-HF intervention on HFrEF medication optimization Hypothesis 1: Compared to usual care, EPIC-HF will increase the number of HFrEF medication optimizations (i.e., dose changes for beta-blockers (βB), Angiotensin-converting enzyme inhibitors (ACE-I)/Angiotensin receptor blockers (ARB)/sacubitril, Aldosterone Receptor Antagonists (AldaA), Ivabradine, etc.) without compromising secondary outcomes including safety and healthcare provider satisfaction.
Aim 2: Assess the effectiveness of the EPIC-HF intervention on patient empowerment and activation around their HFrEF medication plan Hypothesis 2: Compared to usual care, EPIC-HF will result in increased patient empowerment and activation around their HFrEF medication plan as measured through patient self-assessment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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'.
Behavioral: No Intervention--Usual Care
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.'
Behavioral: 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.
Control for intervention--patient receives care as usual from provider to contrast against intervention arm.
Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT)
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.
Time frame: Enrollment, 1 month (30 days) after enrollment
Self-Reported Patient Engagement Around HFrEF Medications
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.
Time frame: 1 month after delivery of intervention materials.
Number of Participants With Initiation/Intensification of Key Heart Failure Medications
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.
Time frame: Enrollment, 1 month (30 days) after enrollment
Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient
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)
Time frame: Enrollment, 1 month (30 days) after enrollment
Safety Outcomes
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.
Time frame: Enrollment, 1-month (30 days) after Enrollment
| Milestone | Control | Intervention |
|---|---|---|
| Started | 153 | 153 |
| Completed | 145 | 145 |
| Not completed | 8 | 8 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Never had qualifying clinic visit | 7 | 7 |
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.
| percentage of participants | Control | Intervention |
|---|---|---|
| Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT) | 29.7 | 49.0 |
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.
| Participants | Intervention - Only |
|---|---|
| Reported receiving the video | 81 |
| Reported reviewing the video | 73 |
| Found the video helpful in understanding their medical plan | 53 |
| Found the video helpful in discussing their medicines with their doctor | 51 |
| Reported receiving the checklist | 83 |
| Reported reviewing the checklist | 74 |
| Found the checklist helpful in understanding their medical plan | 56 |
| Found the checklist helpful in discussing their medicines with their doctor | 48 |
| Brought the checklist to their appointment | 61 |
| Talked about checklist with doctor at their appointment | 52 |
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.
| Participants | Control | Intervention |
|---|---|---|
| Intensification occurring during cardiology clinic visit (day 1) | 42 | 61 |
| Any intensification in HFrEF medication, including GDMT, loop diuretic, or digoxin | 45 | 73 |
| Key heart failure medication added | 10 | 17 |
| Beta blocker added | 2 | 0 |
| ACE-I added | 1 | 4 |
| ARB added | 4 | 2 |
| ARNI added | 0 | 0 |
| Loop diuretic added | 0 | 0 |
| Aldosterone antagonist added | 3 | 5 |
| Ivabradine added | 0 | 1 |
| Hydralazine added | 1 | 1 |
| Isosorbide added | 1 | 2 |
| Digoxin added | 0 | 0 |
| ACE-I or ARB replaced with ARNI | 3 | 4 |
| Key heart failure medication up titrated | 33 | 58 |
| Beta blocker up titrated | 16 | 32 |
| ACE-I up titrated | 4 | 7 |
| ARB up titrated | 7 | 7 |
| ARNI up titrated | 5 | 6 |
| Loop diuretic up titrated | 1 | 0 |
| Aldosterone antagonist up titrated | 3 | 8 |
| Ivabradine up titrated | 0 | 0 |
| Hydralazine up titrated | 0 | 2 |
| Isosorbide up titrated | 0 | 1 |
| Digoxin up titrated | 0 | 0 |
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)
| intensifications | Control | Intervention |
|---|---|---|
| # of GDMT intensifications (initiation/dose increase EVBB, ACEI, ARB, ARNI, MRA, H/ISDN, or Iva) | 0.36 ± 0.61 | 0.61 ± 0.73 |
| # of all intensifications (including GDMT plus initiation or uptitration of loop diuretic or digoxin | 0.38 ± 0.62 | 0.63 ± 0.73 |
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.
| participants | Control | Intervention |
|---|---|---|
| Unplanned hospitalization at 30 days | 4 | 6 |
| Emergency department visit without hospitalization at 30 days | 5 | 9 |
Collected over 1 month (30 days) from Enrollment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 1/145 (0.7%) | 0/145 (0%) | 0/145 (0%) |
| Intervention | 0/145 (0%) | 0/145 (0%) | 0/145 (0%) |
| Age, Customized(years) | Control | Intervention | Total |
|---|---|---|---|
| Age | 64 (55 to 72) | 66 (58 to 74) | 65 (56.5 to 73) |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 43 | 41 | 84 |
| Male | 102 | 104 | 206 |
| Ethnicity (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 11 | 20 |
| Not Hispanic or Latino | 136 | 134 | 270 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 14 | 30 |
| White | 120 | 119 | 239 |
| More than one race | 5 | 7 | 12 |
| Unknown or Not Reported | 4 | 5 | 9 |
| Employment(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Employed | 45 | 46 | 91 |
| Retired | 59 | 72 | 131 |
| Unemployed | 39 | 23 | 62 |
| Missing | 2 | 4 | 6 |
| Insurance(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Medicare, Tricare | 71 | 73 | 144 |
| Medicaid | 23 | 21 | 44 |
| Private | 48 | 48 | 96 |
| None | 3 | 3 | 6 |
| Income(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Less than or equal to $20,000 | 31 | 24 | 55 |
| $20,001--$40,000 | 31 | 17 | 48 |
| $40,001--$60,000 | 15 | 20 | 35 |
| $60,001--$80,000 | 27 | 29 | 56 |
| Greater than $80,000 | 32 | 44 | 76 |
| Missing | 9 | 11 | 20 |
| Single Relationship Status(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Count of participants | 59 | 56 | 115 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Nov 2020, 34 months.
Results were first posted in Sep 2021, 10 months after primary completion.
Of 219 non-industry interventional studies with no phase under Patient Participation, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 34 months is above that.
Counting every sponsor, half of 226 studies reached it within 20 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →