Heart FailureNCT05564572
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
A study testing Routine Health Status Assessment in people with Heart Failure, run by Stanford University at 1 site in United States.
Trial summary
This randomized quality improvement study evaluates the routine assessment of patient-reported heath status, using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) among adult outpatients seen in heart failure clinic or seen in general cardiology clinic with a history of heart failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Routine Health Status Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 7 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Seen in Stanford general cardiology clinic with a diagnosis of heart failure or cardiomyopathy or in heart failure clinic
Who cannot join
- Enrolled in PRO-HF trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital & Clinics
Stanford, California, 94305
About this study
This randomized quality improvement study evaluates the routine assessment of patient-reported heath status, using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) among adult outpatients seen in heart failure clinic or seen in general cardiology clinic with a history of heart failure. Patients will be randomized 4:1 to KCCQ-12 assessment or usual care. Participants randomized to KCCQ-12 assessment will complete the KCCQ-12 at every heart failure clinic visit. Their results will be available to clinicians to assist with clinical management. Heath status surveys will not be integrated into clinical care for patients in the usual care arm. The primary objective is to evaluate the impact of routine assessment of patient-reported heath status on clinical processes of care. As the primary outcome, we will evaluate clinician inertia by measuring the clinician action rating (CAR) - an aggregate count of medication changes, referrals, and diagnostic tests. As secondary outcomes, we will measure individual components of the composite outcome, therapy rates, resource utilization, and patient experience.
- Conditions
- Heart Failure
- Being tested
- Routine Health Status Assessment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Health Status AssessmentOther
Completion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record.
| Study group | Role | What they receive |
|---|---|---|
| Health Status Assessment | Experimental | Completion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record. Receives: Other: Routine Health Status Assessment |
| Usual Care | No intervention | Patients will not complete a patient-reported health status measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician action rating
Aggregate count of medication changes, referrals, and diagnostic tests ordered per clinic visit
Measured: From date of randomization to study completion (up to 12 months)
Secondary outcomes (18)
Medication Changes
Number of medication changes per cardiology clinic visit (initiation, discontinuation, dose adjustment)
Measured: From date of randomization to study completion (up to 12 months)
Referrals
Number of referrals per cardiology clinic visit
Measured: From date of randomization to study completion (up to 12 months)
Diagnostic Tests
Number of diagnostic tests ordered per cardiology clinic visit
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Beta-blocker Therapy and Median Dose Among Patients with Reduced Ejection Fraction
Beta-blocker therapy use among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors and Median Dose Among Patients with Reduced Ejection Fraction
Use of any renin-angiotensin-aldosterone system inhibitors among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. These include angiotensin-converting enzyme inhibitor, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors. Among those patients on therapy, the specific medication and dose will be collected.
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Mineralocorticoid Receptor Antagonist and Median Dose Among Patients with Reduced Ejection Fraction
Mineralocorticoid receptor antagonist use among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.
Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Sacubitril-Valsartan and Median Dose Among Patients with Reduced Ejection Fraction
Use of any sacubitril-valsartan among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. These include angiotensin-converting enzyme inhibitor, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors. Among those patients on therapy, the specific medication and dose will be collected.
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients on SGLT2i
Use of any SGLT2i
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients with a Implantable Cardiac Defibrillator Among Patients with Reduced Ejection Fraction
Presence of an implantable cardiac defibrillator among the sub-group of patients with baseline left ventricular ejection fraction ≤ 35%.
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients with a Cardiac Resynchronization Therapy Device Among Patients with Reduced Ejection
Presence of cardiac resynchronization therapy among the sub-group of patients with baseline left ventricular ejection fraction ≤ 35% with electrocardiogram findings consistent with the guideline recommendation for cardiac resynchronization therapy.
Measured: From date of randomization to study completion (up to 12 months)
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction
Referral to cardiac rehabilitation among the subgroup of patients with baseline left ventricular ejection fraction ≤ 35%.
Measured: From date of randomization to study completion (up to 12 months)
Hospitalizations
Number of heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.
Measured: From date of randomization to study completion (up to 12 months)
Emergency Department Visits
Number of Stanford emergency department visits during the follow-up period
Measured: From date of randomization to study completion (up to 12 months)
Cardiology Clinic Visits
Number of visits (in-person or telemedicine) to general cardiology or heart failure clinics during the follow-up period
Measured: From date of randomization to study completion (up to 12 months)
Telephone Encounters
Number of telephone encounters with general cardiology or heart failure clinics during the follow-up period
Measured: From date of randomization to study completion (up to 12 months)
Formal Advanced Heart Failure Therapy Evaluation
Number of patients who undergo formal evaluation for advanced heart failure therapies (LVAD or transplant)
Measured: From date of randomization to study completion (up to 12 months)
Quality of Patient Clinic Experience
Patient report of satisfaction with clinic visit based on existing Stanford patient experience survey
Measured: From date of randomization to study completion (up to 12 months)
Diagnostic Testing
Number of diagnostic tests ordered in cardiology clinic (cardiac imaging [echocardiography, MRI, angiography, CT angiography, PET], non-cardiac imaging, rhythm monitoring, exercise testing, invasive hemodynamics, pulmonary function testing) during the follow-up period
Measured: From date of randomization to study completion (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start7 Sep 2022
- Primary completion7 Sep 2023 (estimated)
- Study completion7 Dec 2023 (estimated)
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.
- More trials run by Stanford 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
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Sandhu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564572
- Sponsor's protocol ID
- 67173
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 3 Oct 2022
- 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 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
- ClinicalTrials.gov ID
- NCT05564572
- Acronym / sponsor ID
- 67173
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 7 Sep 2023 (estimated)
- Study completion
- 7 Dec 2023 (estimated)
- First posted
- 3 Oct 2022 (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 randomized quality improvement study evaluates the routine assessment of patient-reported heath status, using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) among adult outpatients seen in heart failure clinic or seen in general cardiology clinic with a history of heart failure. Patients will be randomized 4:1 to KCCQ-12 assessment or usual care. Participants randomized to KCCQ-12 assessment will complete the KCCQ-12 at every heart failure clinic visit. Their results will be available to clinicians to assist with clinical management. Heath status surveys will not be integrated into clinical care for patients in the usual care arm. The primary objective is to evaluate the impact of routine assessment of patient-reported heath status on clinical processes of care. As the primary outcome, we will evaluate clinician inertia by measuring the clinician action rating (CAR) - an aggregate count of medication changes, referrals, and diagnostic tests. As secondary outcomes, we will measure individual components of the composite outcome, therapy rates, resource utilization, and patient experience.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Status Assessment | Experimental | Other: Routine Health Status AssessmentCompletion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record. |
| Usual Care | No intervention | –Patients will not complete a patient-reported health status measures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Seen in Stanford general cardiology clinic with a diagnosis of heart failure or cardiomyopathy or in heart failure clinic
Key exclusion criteria (1 listed)
- Enrolled in PRO-HF trial
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 |
|---|---|---|
| Routine Health Status AssessmentCompletion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record. | Other | Health Status Assessment |
Primary outcome
Clinician action rating
Time frame: From date of randomization to study completion (up to 12 months)
Aggregate count of medication changes, referrals, and diagnostic tests ordered per clinic visit
18 secondary outcomes
Medication Changes
Time frame: From date of randomization to study completion (up to 12 months)
Referrals
Time frame: From date of randomization to study completion (up to 12 months)
Diagnostic Tests
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Beta-blocker Therapy and Median Dose Among Patients with Reduced Ejection Fraction
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors and Median Dose Among Patients with Reduced Ejection Fraction
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Mineralocorticoid Receptor Antagonist and Median Dose Among Patients with Reduced Ejection Fraction
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients on Sacubitril-Valsartan and Median Dose Among Patients with Reduced Ejection Fraction
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients on SGLT2i
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients with a Implantable Cardiac Defibrillator Among Patients with Reduced Ejection Fraction
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients with a Cardiac Resynchronization Therapy Device Among Patients with Reduced Ejection
Time frame: From date of randomization to study completion (up to 12 months)
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction
Time frame: From date of randomization to study completion (up to 12 months)
Hospitalizations
Time frame: From date of randomization to study completion (up to 12 months)
Emergency Department Visits
Time frame: From date of randomization to study completion (up to 12 months)
Cardiology Clinic Visits
Time frame: From date of randomization to study completion (up to 12 months)
Telephone Encounters
Time frame: From date of randomization to study completion (up to 12 months)
Formal Advanced Heart Failure Therapy Evaluation
Time frame: From date of randomization to study completion (up to 12 months)
Quality of Patient Clinic Experience
Time frame: From date of randomization to study completion (up to 12 months)
Diagnostic Testing
Time frame: From date of randomization to study completion (up to 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- 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 Routine Health Status Assessment in people with Heart Failure, run by Stanford University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2022. 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?
Results are not available in the source record.
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?
Clinician action rating (time frame: From date of randomization to study completion (up to 12 months)). 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 3 Oct 2022.