Heart FailureNCT02148341
Implementation of the Hospital to Home (H2H) Heart Failure Initiative
A study testing Community of Practice Facilitation in people with Heart Failure, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
This study determines if a community of practice of clinicians and quality improvement specialists can be used to implement a national quality initiative known as Hospital to Home (H2H). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Community of Practice Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2013
- 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
- VA medical centers are the unit of randomization. A medical center will be included if had at least 20 patients discharged with a principal diagnosis of heart failure in 2008
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
This study determines if a community of practice of clinicians and quality improvement specialists can be used to implement a national quality initiative known as Hospital to Home (H2H). This quality initative is designed to reduced readmission rates for patients with heart failure or heart attack by improving the transition of care upon discharge.
- Conditions
- Heart Failure
- Being tested
- Community of Practice Facilitation, Usual Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community of Practice FacilitationOther
Usual CareOther
| Study group | Role | What they receive |
|---|---|---|
| Community of Practice Facilitation | Experimental | Medical Centers assigned to this arm will recieive the communtiy of practice facilitation. In this process we will contact existing members of the community of practice (called the Heart Failure Network) at the facility as well as attempt to identify new providers and other staff at the facility with an interest in improving heart failure care. The facilitation includes: describing the national H2H program, providing talking points and strategies for local providers to obtain support from their local facility to initiate local projects related to H2H, providing a forum for successful sites to describe how they initiated projects to sites yet to initiate projects. Receives: Other: Community of Practice Facilitation |
| Usual Care | Experimental | Medical centers in this arm will hear of H2H through usual routs (calls with facilty Directors and Chiefs of staff). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
H2H enrollment
H2H enrollment by the facility as determined by the H2H program of the American College of Cardiology and Institute for Healthcare Improvement
Measured: 6 months
Secondary outcomes (1)
quality improvement programs initiated due to H2H
A new quality improvement initiated that addressess one of the 3 areas of H2H focus. These include, medication reconcilliation, early follow-up after discharge, and symptom recognition.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionJul 2013
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Heidenreich, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148341
- Sponsor's protocol ID
- SDP-09-160
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2013
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Hospital to Home (H2H) Heart Failure Initiative
- ClinicalTrials.gov ID
- NCT02148341
- Acronym / sponsor ID
- SDP-09-160
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 May 2014 (estimated)
- 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 determines if a community of practice of clinicians and quality improvement specialists can be used to implement a national quality initiative known as Hospital to Home (H2H). This quality initative is designed to reduced readmission rates for patients with heart failure or heart attack by improving the transition of care upon discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community of Practice Facilitation | Experimental | Other: Community of Practice FacilitationMedical Centers assigned to this arm will recieive the communtiy of practice facilitation. In this process we will contact existing members of the community of practice (called the Heart Failure Network) at the facility as well as attempt to identify new providers and other staff at the facility with an interest in improving heart failure care. The facilitation includes: describing the national H2H program, providing talking points and strategies for local providers to obtain support from their local facility to initiate local projects related to H2H, providing a forum for successful sites to describe how they initiated projects to sites yet to initiate projects. |
| Usual Care | Experimental | Other: Usual CareMedical centers in this arm will hear of H2H through usual routs (calls with facilty Directors and Chiefs of staff). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- VA medical centers are the unit of randomization. A medical center will be included if had at least 20 patients discharged with a principal diagnosis of heart failure in 2008
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Community of Practice Facilitation | Other | Community of Practice Facilitation |
| Usual Care | Other | Usual Care |
Primary outcome
H2H enrollment
Time frame: 6 months
H2H enrollment by the facility as determined by the H2H program of the American College of Cardiology and Institute for Healthcare Improvement
1 secondary outcome
quality improvement programs initiated due to H2H
Time frame: 6 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 28 May 2014.
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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.
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 Community of Practice Facilitation in people with Heart Failure, run by VA Palo Alto Health Care System 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 0 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 28 May 2014. 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?
H2H enrollment (time frame: 6 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 28 May 2014.