Heart FailureGREAT-HF CareNCT05990296
Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care
A study testing Multiprong CDS with referral to pharmacist co-management, Multiprong CDS with GDMT order set and Focused education in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Geisinger Clinic at 1 site in United States.
Trial summary
Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and adverse events (hospitalization or urgent outpatient visits for HF), along with diminished quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Multiprong CDS with referral to pharmacist co-management, Multiprong CDS with GDMT order set and Focused education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,306 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 17 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older AND
- Completed visit at included Geisinger cardiology outpatient clinics (office visit or telemedicine) AND
- Clinicians are on a list of currently active Geisinger clinicians in outpatient cardiology clinics who can prescribe heart failure medications AND
- Active problem list diagnosis of HFrEF at time of Cardiology clinic encounter OR Left Ventricular Ejection Fraction (LVEF) < 40: most recent to the cardiology clinic encounter within 2 years of the visit.
Who cannot join
- Currently in hospice or palliative care (ICD 10 code: Z51.5)
- Patient is allergic to each category of GDMT
- Patient is prescribed medications from all four categories of GDMT, including ARNI specifically
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Cardiology Clinics
Danville, Pennsylvania, 17822
About this study
Official title: Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)
Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and adverse events (hospitalization or urgent outpatient visits for HF), along with diminished quality of life. Despite convincing data that evidenced-based, guideline-directed medical therapies (GDMT) improve mortality and heart failure-related events, there remains insufficient utilization of these life-saving drugs (evidence-based beta-blockers (EBBB), angiotensin-neprilysin inhibitors (ARNI)/ angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blockers (ARB), mineralocorticoid receptor antagonists (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with HFrEF. The primary objective of this study is to implement and evaluate a multifaceted, interdisciplinary intervention to improve GDMT use, reduce mortality, and reduce future heart failure events in patients with HFrEF.
Read the detailed description
This is a cluster randomized study designed to evaluate the effectiveness of interventions aimed at improving GDMT in patients with HFrEF. Clinicians stratified based on practice specialty, location, and pharmacist referral habits will be permuted block randomized to achieve 45%/45%/10% proportional distribution across the following arms respectively: (1) usual care, (2) multi-pronged clinical decision support (CDS) inclusive of a patient portal message about GDMT, an interruptive advisory upon chart entry as a notification to clinicians on GDMT consideration and a Best Practice Advisory (BPA) that includes a GDMT order set, and (3) multi-pronged CDS as in #2 but replacement of GDMT order set with referral to integrated clinical pharmacist co-management. Secondarily, each of the 5 clinical practice sites of roughly equal HFrEF patient loads were assigned to receive either an early or delayed education rollout. Exploratory analyses will look to determine the independent and incremental benefits of education with other interventional approaches.
- Being tested
- Multiprong CDS with referral to pharmacist co-management, Multiprong CDS with GDMT order set, Focused education
- Keywords
- Heart Failure with Reduced Ejection Fraction, Guideline Directed Medical Therapy, Angiotensin-neprilysin inhibitors (ARNI), Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Clinical Decision Support, Best Practice Alert, Pharmacist, Education, Behavioral Economics, Best Practice Advisory
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprong CDS with referral to pharmacist co-managementBehavioural
Also called Opt-out default, Active choice, Advisory, Alert
Accepting the clinician-facing BPA default recommendation will have eligible patients within this arm referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient.
Multiprong CDS with GDMT order setBehavioural
Also called Opt-out default, Active choice, Default order of options, Advisory
Accepting the clinician-facing BPA default recommendation will open an order set for GDMT that lists common recommended options in such a way that facilitates optimal prescribing. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient.
Focused educationBehavioural
Also called Education, Training, Interactive
A series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Clinicians in this arm will not receive CDS or focused education and will experience usual care. |
| Multiprong CDS with GDMT order set | Experimental | Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The CDS will inform, encourage, and facilitate prescribing of GDMT via a focused order set. Receives: Behavioral: Multiprong CDS with GDMT order set |
| Multiprong CDS with referral to pharmacist co-management | Experimental | Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Receives: Behavioral: Multiprong CDS with referral to pharmacist co-management |
| Focused education | Experimental | Clinicians in this arm will receive focused education and no CDS. Receives: Behavioral: Focused education |
| Multiprong CDS with GDMT order set + focused education | Experimental | Clinicians in this arm will receive focused education in addition to clinician BPA heads-up and BPA with GDMT order set for their eligible patients with HFrEF. Receives: Behavioral: Multiprong CDS with GDMT order set; Behavioral: Focused education |
| Multiprong CDS with referral to pharmacist co-management + focused education | Experimental | Clinicians in this arm will receive focused education along with clinicians/patient CDS. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Receives: Behavioral: Multiprong CDS with referral to pharmacist co-management; Behavioral: Focused education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF GDMT prescription increased (yes/no)
New GDMT HF medication class added, switch to ARNI from ACE/ARB, or upward dose titration of existing GDMT HF medication.
Measured: Within 30 days of index visit
Secondary outcomes (2)
HF GDMT prescription increased (yes/no)
New GDMT HF medication class added, switch to ARNI from ACEi/ARB, or upward dose titration of existing GDMT HF medication.
Measured: Within 60 and 90 days of index visit
Addition of SGLT2i or ARNI for HFrEF (yes/no)
New prescriptions for SGLT2i and/or ARNI or switch from ACEi/ARB to ARNI
Measured: Within 30, 60 and 90 days of index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023
- Primary completion17 Feb 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, multiprong CDS with GDMT order set, and multiprong CDS with referral to pharmacist co-management, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.
- Masking
- None (open label)
- Enrolment
- 4,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Voyce, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990296
- Sponsor's protocol ID
- 2023-1031
- Acronym
- GREAT-HF Care
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)
- ClinicalTrials.gov ID
- NCT05990296
- Acronym / sponsor ID
- GREAT-HF Care / 2023-1031
- Keywords
- Heart Failure with Reduced Ejection Fraction, Guideline Directed Medical Therapy, Angiotensin-neprilysin inhibitors (ARNI), Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Clinical Decision Support, Best Practice Alert, Pharmacist, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,306 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and adverse events (hospitalization or urgent outpatient visits for HF), along with diminished quality of life. Despite convincing data that evidenced-based, guideline-directed medical therapies (GDMT) improve mortality and heart failure-related events, there remains insufficient utilization of these life-saving drugs (evidence-based beta-blockers (EBBB), angiotensin-neprilysin inhibitors (ARNI)/ angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blockers (ARB), mineralocorticoid receptor antagonists (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with HFrEF. The primary objective of this study is to implement and evaluate a multifaceted, interdisciplinary intervention to improve GDMT use, reduce mortality, and reduce future heart failure events in patients with HFrEF.
Detailed description
This is a cluster randomized study designed to evaluate the effectiveness of interventions aimed at improving GDMT in patients with HFrEF. Clinicians stratified based on practice specialty, location, and pharmacist referral habits will be permuted block randomized to achieve 45%/45%/10% proportional distribution across the following arms respectively: (1) usual care, (2) multi-pronged clinical decision support (CDS) inclusive of a patient portal message about GDMT, an interruptive advisory upon chart entry as a notification to clinicians on GDMT consideration and a Best Practice Advisory (BPA) that includes a GDMT order set, and (3) multi-pronged CDS as in #2 but replacement of GDMT order set with referral to integrated clinical pharmacist co-management. Secondarily, each of the 5 clinical practice sites of roughly equal HFrEF patient loads were assigned to receive either an early or delayed education rollout. Exploratory analyses will look to determine the independent and incremental benefits of education with other interventional approaches.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, multiprong CDS with GDMT order set, and multiprong CDS with referral to pharmacist co-management, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Clinicians in this arm will not receive CDS or focused education and will experience usual care. |
| Multiprong CDS with GDMT order set | Experimental | Behavioral: Multiprong CDS with GDMT order setClinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The CDS will inform, encourage, and facilitate prescribing of GDMT via a focused order set. |
| Multiprong CDS with referral to pharmacist co-management | Experimental | Behavioral: Multiprong CDS with referral to pharmacist co-managementClinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. |
| Focused education | Experimental | Behavioral: Focused educationClinicians in this arm will receive focused education and no CDS. |
| Multiprong CDS with GDMT order set + focused education | Experimental | Behavioral: Multiprong CDS with GDMT order set, Behavioral: Focused educationClinicians in this arm will receive focused education in addition to clinician BPA heads-up and BPA with GDMT order set for their eligible patients with HFrEF. |
| Multiprong CDS with referral to pharmacist co-management + focused education | Experimental | Behavioral: Multiprong CDS with referral to pharmacist co-management, Behavioral: Focused educationClinicians in this arm will receive focused education along with clinicians/patient CDS. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older AND
- Completed visit at included Geisinger cardiology outpatient clinics (office visit or telemedicine) AND
- Clinicians are on a list of currently active Geisinger clinicians in outpatient cardiology clinics who can prescribe heart failure medications AND
- Active problem list diagnosis of HFrEF at time of Cardiology clinic encounter OR Left Ventricular Ejection Fraction (LVEF) < 40: most recent to the cardiology clinic encounter within 2 years of the visit.
Key exclusion criteria (3 listed)
- Currently in hospice or palliative care (ICD 10 code: Z51.5)
- Patient is allergic to each category of GDMT
- Patient is prescribed medications from all four categories of GDMT, including ARNI specifically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiprong CDS with referral to pharmacist co-managementAlso: Opt-out default, Active choice, Advisory, AlertAccepting the clinician-facing BPA default recommendation will have eligible patients within this arm referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient. | Behavioural | Multiprong CDS with referral to pharmacist co-management, Multiprong CDS with referral to pharmacist co-management + focused education |
| Multiprong CDS with GDMT order setAlso: Opt-out default, Active choice, Default order of options, AdvisoryAccepting the clinician-facing BPA default recommendation will open an order set for GDMT that lists common recommended options in such a way that facilitates optimal prescribing. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient. | Behavioural | Multiprong CDS with GDMT order set, Multiprong CDS with GDMT order set + focused education |
| Focused educationAlso: Education, Training, InteractiveA series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings. | Behavioural | Focused education, Multiprong CDS with GDMT order set + focused education, Multiprong CDS with referral to pharmacist co-management + focused education |
Primary outcome
HF GDMT prescription increased (yes/no)
Time frame: Within 30 days of index visit
New GDMT HF medication class added, switch to ARNI from ACE/ARB, or upward dose titration of existing GDMT HF medication.
2 secondary outcomes
HF GDMT prescription increased (yes/no)
Time frame: Within 60 and 90 days of index visit
Addition of SGLT2i or ARNI for HFrEF (yes/no)
Time frame: Within 30, 60 and 90 days of index visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiprong CDS with referral to pharmacist co-management, Multiprong CDS with GDMT order set and Focused education in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HF GDMT prescription increased (yes/no) (time frame: Within 30 days of index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.