Heart FailurePhase 3NCT00204802
Patient-Centered Advance Care Planning
A Phase 3 study testing Patient-Centered Advance Care Planning in people with Heart Failure and Renal Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Renal Failure
- What is being tested?
- Patient-Centered Advance Care Planning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 313 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jul 2008
- Phase
- Phase 3
- 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
- At high risk for impending death in the next 12 months
Who cannot join
- Patient not having decision-making capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease
Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.
- Conditions
- Heart Failure, Renal Failure
- Being tested
- Patient-Centered Advance Care Planning
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered Advance Care PlanningBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of PC-ACP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJul 2007
- Study completionJul 2008
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin T Kirchhoff, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204802
- Sponsor's protocol ID
- 2003-165
- Status last verified
- Mar 2009
- First submitted
- 12 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
Publications
Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
PubMed 36472416Kirchhoff KT, Hammes BJ, Kehl KA, Briggs LA, Brown RL. Effect of a disease-specific planning intervention on surrogate understanding of patient goals for future medical treatment. J Am Geriatr Soc. 2010 Jul;58(7):1233-40. doi: 10.1111/j.1532-5415.2010.02760.x.
PubMed 20649686
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease
- ClinicalTrials.gov ID
- NCT00204802
- Acronym / sponsor ID
- 2003-165
- Conditions
- Heart Failure, Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Sep 2005 (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.
Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At high risk for impending death in the next 12 months
Key exclusion criteria (1 listed)
- Patient not having decision-making capacity
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 |
|---|---|---|
| Patient-Centered Advance Care Planning | Behavioural | – |
Primary outcome
efficacy of PC-ACP
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 5 Oct 2015.
- Derived from this study: PubMed 36472416Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
- Derived from this study: PubMed 20649686Kirchhoff KT, Hammes BJ, Kehl KA, Briggs LA, Brown RL. Effect of a disease-specific planning intervention on surrogate understanding of patient goals for future medical treatment. J Am Geriatr Soc. 2010 Jul;58(7):1233-40. doi: 10.1111/j.1532-5415.2010.02760.x.
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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.
Karin T Kirchhoff, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patient-Centered Advance Care Planning in people with Heart Failure and Renal Failure, run by University of Wisconsin, Madison 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: finished, as of the sponsor's last update on 5 Oct 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy of PC-ACP. 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 NCT00204802, 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 5 Oct 2015; AzTrials last refreshed its copy on 1 Nov 2026.