Chronic Heart FailureNCT04793880
Cost and Shared Decision-Making for Heart Failure
A study testing Medication Cost Information and Heart Failure Medicines Checklist in people with Chronic Heart Failure, run by Emory University at 4 sites in United States.
Trial summary
This study is designed to understand the impact of providing patient-specific cost at the time of the clinical encounter on decision-making for heart failure medications. The researchers will provide patients with heart failure with patient-specific cost information for non-generic heart failure medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Medication Cost Information and Heart Failure Medicines Checklist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2021to 15 Nov 2023
- 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
- Diagnosis of HFrEF (ejection fraction < 40%)
- Outpatient clinical encounter with cardiologist (virtual or in-person)
Who cannot join
- Advanced HF therapy (LVAD or transplant or undergoing active workup or listing for these therapies; home inotrope usage)
- Patient currently in hospice care or with known life expectancy under 1 year
- Dialysis-dependence or glomerular filtration rate (GFR) < 30 (due to medication contraindications)
- Pregnancy (because many guideline-recommended drugs, including those with associated high costs, are not approved for use in pregnancy)
- Non-English speaking (because of the absence of non-English speaking research staff to communicate with non-English speaking patients and to qualitatively analyze/code audio-recorded data)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory Clinic, Emory University Hospital
Atlanta, Georgia, 30322
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
UCHealth Heart and Vascular Center Clinics
Aurora, Colorado, 80045
About this study
Official title: Integrating Cost Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction
This study is designed to understand the impact of providing patient-specific cost at the time of the clinical encounter on decision-making for heart failure medications. The researchers will provide patients with heart failure with patient-specific cost information for non-generic heart failure medications. This cost information will be populated onto a checklist of recommended HF medications so that patients and their clinicians will have this information available during their clinical encounter. Patients in the control arm will receive the same checklist but without the cost information.
Read the detailed description
For many years, medical treatment of heart failure with reduced ejection fraction (HFrEF) was defined by a combination of low-cost, generic medications. Recently, new medications have demonstrated reductions in mortality and hospitalization. These include the angiotensin receptor blocker and neprilysin inhibitor (ARNI) sacubitril-valsartan, sodium-glucose cotransporter-2 inhibitors (SGLT2I), and ivabradine. These medications all carry important clinical benefits but also are more expensive, with co-payments varying significantly but often in the range of $50-$100 per month. These costs are highly relevant for patients' decisions, especially for patients who have Medicare Part D drug coverage and are not eligible for co-pay assistance programs.
Prior research has demonstrated that patients are sensitive to costs regarding HFrEF medications and receptive to cost discussions with clinicians. Some broad efforts at price transparency have been promoted, but generic price information is of little value to patients and clinicians when out-of-pocket costs vary significantly from patient to patient based on insurance coverage. At present, neither clinicians nor patients have out-of-pocket costs available at the time of clinical encounters in order to facilitate integration of this information into decisions.
The objective of this trial is to examine the impact of integrating patient-specific out-of-pocket cost into shared decision-making regarding heart failure medications in patients with HFrEF. This will be performed by integrating patient-specific cost into an existing, evidence-based checklist for HFrEF medications. The study will utilize a simple cluster-randomized design. All patients in the study will receive, at the time of a clinical encounter, an evidence-based heart failure medication checklist that describes guideline-recommended medications for HFrEF. Patients in the intervention group will receive a version of the checklist that also includes their estimated co-payment for non-generic heart failure medications based upon their insurance status at the time of the encounter.
This study is designed as a preliminary trial to understand the real impact of providing patient-specific cost at the time of the clinical encounter. The researchers will audio record clinical encounters, conduct a follow-up survey with participants, and collect follow-up data regarding each patient's medications.
- Conditions
- Chronic Heart Failure
- Being tested
- Medication Cost Information, Heart Failure Medicines Checklist
- Keywords
- Out-of-pocket cost, Shared decision-making, Heart failure with reduced ejection fraction (HFrEF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Cost InformationBehavioural
This version of the HFrEF medication checklist includes patient-specific estimated monthly out-of-pocket cost for each medication. TailorMed, a company designed to provide financial counseling and planning for patients, will generate the patients' out-of-pocket cost based on insurance status. The costs for non-generic HFrEF medications will then be populated onto a checklist of recommended heart failure medications so that patients and their clinicians will have this information available during their clinical encounter.
Heart Failure Medicines ChecklistBehavioural
The Heart Failure Medicines Checklist is an evidence-based medication checklist that describes guideline-recommended medications for HFrEF. This tool is used during the clinical encounter to facilitate a discussion about medications that may be most appropriate for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Medication checklist with cost information | Experimental | Participants with chronic heart failure with reduced ejection fraction (HFrEF) having a clinic visit at a site randomized to the medication checklist with cost information intervention. Receives: Behavioral: Medication Cost Information; Behavioral: Heart Failure Medicines Checklist |
| Medication checklist | Active comparator | Participants with chronic heart failure with reduced ejection fraction (HFrEF) having a clinic visit at a site randomized to the medication checklist without cost information. Receives: Behavioral: Heart Failure Medicines Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Discussed Medication Cost
The number of patients whose clinic encounters involved a discussion of heart failure medication cost will be compared between study arms. The discussion of heart failure medication cost is a binary outcome of whether or not the cost of heart failure medication was discussed during the recorded clinical encounter. Any mention of heart failure medication cost will be counted as a cost discussion. The primary outcome will be analyzed using a generalized linear mixed model, with covariates including clinic site, time, age, race, sex, insurance status, and income. Potentially different intervention effects by site and patient characteristics will be examined.
Measured: Day 1 (during clinic encounter)
Secondary outcomes (9)
Physician Recommendation Coding System (PhyReCS) Score
The strength of the clinical recommendation for a medication will be assessed with the Physician Recommendation Coding System (PhyReCS) scale, using the audio recording of the clinic encounter. The PhyReCS is a 5-point scale indicating how strongly the physician recommended a particular treatment. A strong recommendation is coded as +2, a mild recommendation is +1, recommendations neither for nor against treatment are coded as 0, a mild recommendation against treatment is -1, and a strong recommendation against treatment is coded as -2.
Measured: Day 1 (during clinic encounter)
Length of discussion
The length of medication cost discussion will be measured in minutes, using the audio recording of the clinic encounter.
Measured: Day 1 (during clinic encounter)
Helpfulness of medication checklist score
Participants will rate how helpful they found the medication checklist to be on a 5-point scale where 1 = extremely helpful and 5 = not helpful at all.
Measured: 2 to 3 weeks after clinic encounter
Helpfulness of medication checklist with price information score
Participants in the intervention arm will rate how helpful they found the price information included on the medication checklist to be on a 5-point scale where 1 = extremely helpful and 5 = not helpful at all.
Measured: 2 to 3 weeks after clinic encounter
Low Literacy Decisional Conflict Scale score
Participant perception of the visit with their doctor will be assessed with the Low Literacy Decisional Conflict Scale (DCS). The DCS includes 10 questions which are responded to as yes (scored as 0), no (scored as 4), or unsure (scored as 2). Total scores range from 0 to 40 with low scores indicating less difficulty in understanding treatment options.
Measured: 2 to 3 weeks after clinic encounter
Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician & Group Survey score
To assess participant perceptions of their doctor, questions 14-18 of the CAHPS Clinician \& Group Survey - Adult Visit 4.0 (beta) instrument will be used. Responses are given on a 3-point scale where 1 = yes, definitely, 2 = yes, somewhat, and 3 = no. The total score of these 4 items range from 4 to 12 with lower scores indicating a more positive experience with their healthcare provider.
Measured: 2 to 3 weeks after clinic encounter
Prescription of non-generic medications
The number of participants prescribed non-generic medications at the clinic encounter will be obtained from electronic medical records.
Measured: Day 1 (during clinic encounter)
Medication persistence
The number of participants continuing to take their prescribed medication three months after the clinic encounter will be obtained from electronic medical records.
Measured: 3 months after clinic encounter
Clinician perceptions
Clinician perceptions will be assessed qualitatively through focus group interviews.
Measured: End of study (up to 26 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jun 2021
- Primary completion8 Aug 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 study utilizes a stepped wedge cluster-randomized design where study sites are assigned to transition to the intervention as recruitment milestone are met.
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Neal Dickert, Emory University
- Investigators
- Neal W Dickert, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793880
- Sponsor's protocol ID
- STUDY00002215
- Other IDs
- 1R01HS026081-01
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available for sharing upon request, including survey data, electronic health record data, and transcribed interviews.
Publications
Dickert NW, Speight CD, Balser M, Biermann H, Davis JK, Halpern SD, Ko YA, Krishnan A, Matlock DD, Mitchell AR, Moore MA, Montembeau SC, Morris AA, Noonan K, Rao BR, Scherer LD, Sloan CE, Ubel PA, Allen LA. Integrating Out-of-Pocket Costs Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction: A Stepped-Wedge Trial (POCKET-COST-HF). Circ Cardiovasc Qual Outcomes. 2025 Jan;18(1):e011273. doi: 10.1161/CIRCOUTCOMES.124.011273. Epub 2024 Dec 3.
PubMed 39624892Montembeau SC, Rao BR, Mitchell AR, Speight CD, Allen LA, Halpern SD, Ko YA, Matlock DD, Moore MA, Morris AA, Scherer LD, Ubel P, Dickert NW. Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF): A Trial Providing Out-of-Pocket Costs for Heart Failure Medications during Clinical Encounters. Am Heart J. 2024 Mar;269:84-93. doi: 10.1016/j.ahj.2023.11.013. Epub 2023 Dec 12.
PubMed 38096946
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Cost Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT04793880
- Acronym / sponsor ID
- STUDY00002215
- Conditions
- Chronic Heart Failure
- Keywords
- Out-of-pocket cost, Shared decision-making, Heart failure with reduced ejection fraction (HFrEF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 11 Mar 2021 (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.
This study is designed to understand the impact of providing patient-specific cost at the time of the clinical encounter on decision-making for heart failure medications. The researchers will provide patients with heart failure with patient-specific cost information for non-generic heart failure medications. This cost information will be populated onto a checklist of recommended HF medications so that patients and their clinicians will have this information available during their clinical encounter. Patients in the control arm will receive the same checklist but without the cost information.
Detailed description
For many years, medical treatment of heart failure with reduced ejection fraction (HFrEF) was defined by a combination of low-cost, generic medications. Recently, new medications have demonstrated reductions in mortality and hospitalization. These include the angiotensin receptor blocker and neprilysin inhibitor (ARNI) sacubitril-valsartan, sodium-glucose cotransporter-2 inhibitors (SGLT2I), and ivabradine. These medications all carry important clinical benefits but also are more expensive, with co-payments varying significantly but often in the range of $50-$100 per month. These costs are highly relevant for patients' decisions, especially for patients who have Medicare Part D drug coverage and are not eligible for co-pay assistance programs.
Prior research has demonstrated that patients are sensitive to costs regarding HFrEF medications and receptive to cost discussions with clinicians. Some broad efforts at price transparency have been promoted, but generic price information is of little value to patients and clinicians when out-of-pocket costs vary significantly from patient to patient based on insurance coverage. At present, neither clinicians nor patients have out-of-pocket costs available at the time of clinical encounters in order to facilitate integration of this information into decisions.
The objective of this trial is to examine the impact of integrating patient-specific out-of-pocket cost into shared decision-making regarding heart failure medications in patients with HFrEF. This will be performed by integrating patient-specific cost into an existing, evidence-based checklist for HFrEF medications. The study will utilize a simple cluster-randomized design. All patients in the study will receive, at the time of a clinical encounter, an evidence-based heart failure medication checklist that describes guideline-recommended medications for HFrEF. Patients in the intervention group will receive a version of the checklist that also includes their estimated co-payment for non-generic heart failure medications based upon their insurance status at the time of the encounter.
This study is designed as a preliminary trial to understand the real impact of providing patient-specific cost at the time of the clinical encounter. The researchers will audio record clinical encounters, conduct a follow-up survey with participants, and collect follow-up data regarding each patient's medications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilizes a stepped wedge cluster-randomized design where study sites are assigned to transition to the intervention as recruitment milestone are met.
| Arm | Type | Receives |
|---|---|---|
| Medication checklist with cost information | Experimental | Behavioral: Medication Cost Information, Behavioral: Heart Failure Medicines ChecklistParticipants with chronic heart failure with reduced ejection fraction (HFrEF) having a clinic visit at a site randomized to the medication checklist with cost information intervention. |
| Medication checklist | Active comparator | Behavioral: Heart Failure Medicines ChecklistParticipants with chronic heart failure with reduced ejection fraction (HFrEF) having a clinic visit at a site randomized to the medication checklist without cost information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of HFrEF (ejection fraction < 40%)
- Outpatient clinical encounter with cardiologist (virtual or in-person)
Key exclusion criteria (5 listed)
- Advanced HF therapy (LVAD or transplant or undergoing active workup or listing for these therapies; home inotrope usage)
- Patient currently in hospice care or with known life expectancy under 1 year
- Dialysis-dependence or glomerular filtration rate (GFR) < 30 (due to medication contraindications)
- Pregnancy (because many guideline-recommended drugs, including those with associated high costs, are not approved for use in pregnancy)
- Non-English speaking (because of the absence of non-English speaking research staff to communicate with non-English speaking patients and to qualitatively analyze/code audio-recorded data)
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 |
|---|---|---|
| Medication Cost InformationThis version of the HFrEF medication checklist includes patient-specific estimated monthly out-of-pocket cost for each medication. TailorMed, a company designed to provide financial counseling and planning for patients, will generate the patients' out-of-pocket cost based on insurance status. The costs for non-generic HFrEF medications will then be populated onto a checklist of recommended heart failure medications so that patients and their clinicians will have this information available during their clinical encounter. | Behavioural | Medication checklist with cost information |
| Heart Failure Medicines ChecklistThe Heart Failure Medicines Checklist is an evidence-based medication checklist that describes guideline-recommended medications for HFrEF. This tool is used during the clinical encounter to facilitate a discussion about medications that may be most appropriate for the patient. | Behavioural | Medication checklist, Medication checklist with cost information |
Primary outcome
Number of Participants who Discussed Medication Cost
Time frame: Day 1 (during clinic encounter)
The number of patients whose clinic encounters involved a discussion of heart failure medication cost will be compared between study arms. The discussion of heart failure medication cost is a binary outcome of whether or not the cost of heart failure medication was discussed during the recorded clinical encounter. Any mention of heart failure medication cost will be counted as a cost discussion. The primary outcome will be analyzed using a generalized linear mixed model, with covariates including clinic site, time, age, race, sex, insurance status, and income. Potentially different intervention effects by site and patient characteristics will be examined.
9 secondary outcomes
Physician Recommendation Coding System (PhyReCS) Score
Time frame: Day 1 (during clinic encounter)
Length of discussion
Time frame: Day 1 (during clinic encounter)
Helpfulness of medication checklist score
Time frame: 2 to 3 weeks after clinic encounter
Helpfulness of medication checklist with price information score
Time frame: 2 to 3 weeks after clinic encounter
Low Literacy Decisional Conflict Scale score
Time frame: 2 to 3 weeks after clinic encounter
Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician & Group Survey score
Time frame: 2 to 3 weeks after clinic encounter
Prescription of non-generic medications
Time frame: Day 1 (during clinic encounter)
Medication persistence
Time frame: 3 months after clinic encounter
Clinician perceptions
Time frame: End of study (up to 26 months)
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 15 Dec 2023.
- Derived from this study: PubMed 39624892Dickert NW, Speight CD, Balser M, Biermann H, Davis JK, Halpern SD, Ko YA, Krishnan A, Matlock DD, Mitchell AR, Moore MA, Montembeau SC, Morris AA, Noonan K, Rao BR, Scherer LD, Sloan CE, Ubel PA, Allen LA. Integrating Out-of-Pocket Costs Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction: A Stepped-Wedge Trial (POCKET-COST-HF). Circ Cardiovasc Qual Outcomes. 2025 Jan;18(1):e011273. doi: 10.1161/CIRCOUTCOMES.124.011273. Epub 2024 Dec 3.
- Derived from this study: PubMed 38096946Montembeau SC, Rao BR, Mitchell AR, Speight CD, Allen LA, Halpern SD, Ko YA, Matlock DD, Moore MA, Morris AA, Scherer LD, Ubel P, Dickert NW. Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF): A Trial Providing Out-of-Pocket Costs for Heart Failure Medications during Clinical Encounters. Am Heart J. 2024 Mar;269:84-93. doi: 10.1016/j.ahj.2023.11.013. Epub 2023 Dec 12.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available for sharing upon request, including survey data, electronic health record data, and transcribed interviews.
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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.
Neal W Dickert, MD, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Cost Information and Heart Failure Medicines Checklist in people with Chronic Heart Failure, run by Emory University at 4 sites 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 2 inclusion and 5 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Number of Participants who Discussed Medication Cost (time frame: Day 1 (during clinic encounter)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793880, which also lists 2 linked publications.
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 15 Dec 2023.