Heart FailureTHRIVENCT03524534
The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
A study testing Telephone Call and In-Person Primary Care Clinical Follow-Up Visit in people with Heart Failure, run by Kaiser Permanente.
Trial summary
This study is a pragmatic randomized clinical trial to determine the effectiveness of two strategies of early follow-up in adults after hospitalization for heart failure: telephone follow-up with a heart failure care manager vs. in-person clinic visit with their primary care provider. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telephone Call and In-Person Primary Care Clinical Follow-Up Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,091 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All eligible patients hospitalized for confirmed acute heart failure at a Kaiser Permanente Northern California medical center
Who cannot join
- Planned discharge to a location other than their home. This includes a skilled nursing facility, nursing home or hospice facility.
- Planned discharge to home with hospice care.
- End-stage renal disease treated with chronic peritoneal dialysis or hemodialysis.
- Death during the index hospitalization.
About this study
This study is a pragmatic randomized clinical trial to determine the effectiveness of two strategies of early follow-up in adults after hospitalization for heart failure: telephone follow-up with a heart failure care manager vs. in-person clinic visit with their primary care provider. The primary outcomes during 30-day follow-up will include readmission for heart failure, death and readmission for any cause. The study team aims to randomly assign 2400 patients during a 15-month period in a 1-to-1 ratio to either an initial structured telephone call with a heart failure care manager or an in-person primary care clinic visit within 7 days of discharge. A secondary goal is to increase the rate of any follow-up within 7 days of discharge to greater than 90 percent among all eligible patients.
Read the detailed description
Heart failure (HF) affects >5 million adults nationally and is the leading cause of hospitalization among Medicare beneficiaries. Reducing hospitalization for heart failure (HF) and subsequent readmissions shortly after discharge is a nationally recognized health care delivery system priority. More than 20% of Medicare patients hospitalized for HF are readmitted within 30 days and this rate has not been declining over the past decade despite increasing attention to this problem. The data that will be collected could allow the study team to tailor the post-discharge follow-up program to patient characteristics to further improve the effectiveness of the interventions.
- Conditions
- Heart Failure
- Being tested
- Telephone Call, In-Person Primary Care Clinical Follow-Up Visit
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CallOther
A phone call will take place within 7 days of discharge by a Kaiser Permanente Heart Failure Care Manager from the Kaiser Permanente Heart Failure Chronic Care Management Program.
In-Person Primary Care Clinical Follow-Up VisitOther
This will be a standard in-person clinic visit with the subject's primary care physician within 7 days of discharge, with no structured heart failure protocol.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Follow-Up Intervention | Active comparator | Not described Receives: Other: Telephone Call |
| In-person follow-up intervention | Active comparator | Not described Receives: Other: In-Person Primary Care Clinical Follow-Up Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission for heart failure within 30-days
To compare 30-day rates of heart failure-related readmission for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization.
Measured: 30 days after discharge
Secondary outcomes (3)
Readmission for any cause within 30 days
To compare 30-day rates of readmission for any cause for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization.
Measured: 30 days after discharge
Increase in 7-day follow-up rates
To increase follow-up rate within 7 days of discharge to > 90% in eligible patients
Measured: 7 days after discharge
Death from any cause within 30 days
To compare 30-day rates of death from any cause for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization.
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study startJan 2017
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- The Permanente Medical Group
- Responsible party
- Sponsor
- Investigators
- Alan S. Go, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524534
- Sponsor's protocol ID
- CN-16-2667
- Acronym
- THRIVE
- Status last verified
- Jun 2023
- First submitted
- 2 May 2018
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee KK, Thomas RC, Tan TC, Leong TK, Steimle A, Go AS. The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study: A Pragmatic Randomized Trial. Circ Cardiovasc Qual Outcomes. 2020 Oct;13(10):e006553. doi: 10.1161/CIRCOUTCOMES.120.006553. Epub 2020 Sep 24.
PubMed 32967439
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study
- ClinicalTrials.gov ID
- NCT03524534
- Acronym / sponsor ID
- THRIVE / CN-16-2667
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,091 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- The Permanente Medical Group
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 May 2018 (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 a pragmatic randomized clinical trial to determine the effectiveness of two strategies of early follow-up in adults after hospitalization for heart failure: telephone follow-up with a heart failure care manager vs. in-person clinic visit with their primary care provider. The primary outcomes during 30-day follow-up will include readmission for heart failure, death and readmission for any cause. The study team aims to randomly assign 2400 patients during a 15-month period in a 1-to-1 ratio to either an initial structured telephone call with a heart failure care manager or an in-person primary care clinic visit within 7 days of discharge. A secondary goal is to increase the rate of any follow-up within 7 days of discharge to greater than 90 percent among all eligible patients.
Detailed description
Heart failure (HF) affects >5 million adults nationally and is the leading cause of hospitalization among Medicare beneficiaries. Reducing hospitalization for heart failure (HF) and subsequent readmissions shortly after discharge is a nationally recognized health care delivery system priority. More than 20% of Medicare patients hospitalized for HF are readmitted within 30 days and this rate has not been declining over the past decade despite increasing attention to this problem. The data that will be collected could allow the study team to tailor the post-discharge follow-up program to patient characteristics to further improve the effectiveness of the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Follow-Up Intervention | Active comparator | Other: Telephone Call |
| In-person follow-up intervention | Active comparator | Other: In-Person Primary Care Clinical Follow-Up Visit |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All eligible patients hospitalized for confirmed acute heart failure at a Kaiser Permanente Northern California medical center
Key exclusion criteria (4 listed)
- Planned discharge to a location other than their home. This includes a skilled nursing facility, nursing home or hospice facility.
- Planned discharge to home with hospice care.
- End-stage renal disease treated with chronic peritoneal dialysis or hemodialysis.
- Death during the index hospitalization.
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 |
|---|---|---|
| Telephone CallA phone call will take place within 7 days of discharge by a Kaiser Permanente Heart Failure Care Manager from the Kaiser Permanente Heart Failure Chronic Care Management Program. | Other | Telephone Follow-Up Intervention |
| In-Person Primary Care Clinical Follow-Up VisitThis will be a standard in-person clinic visit with the subject's primary care physician within 7 days of discharge, with no structured heart failure protocol. | Other | In-person follow-up intervention |
Primary outcome
Readmission for heart failure within 30-days
Time frame: 30 days after discharge
To compare 30-day rates of heart failure-related readmission for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization.
3 secondary outcomes
Readmission for any cause within 30 days
Time frame: 30 days after discharge
Increase in 7-day follow-up rates
Time frame: 7 days after discharge
Death from any cause within 30 days
Time frame: 30 days after discharge
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 12 Jun 2023.
- Derived from this study: PubMed 32967439Lee KK, Thomas RC, Tan TC, Leong TK, Steimle A, Go AS. The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study: A Pragmatic Randomized Trial. Circ Cardiovasc Qual Outcomes. 2020 Oct;13(10):e006553. doi: 10.1161/CIRCOUTCOMES.120.006553. Epub 2020 Sep 24.
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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.
Alan S. Go, MD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Call and In-Person Primary Care Clinical Follow-Up Visit in people with Heart Failure, run by Kaiser Permanente.
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 4 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Readmission for heart failure within 30-days (time frame: 30 days after discharge). 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 NCT03524534, which also lists 1 linked publication.
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 12 Jun 2023.