Advance Care PlanningNCT03229811

Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program

A study testing ESRD education + conservative kidney management and ACP education in people with Advance Care Planning and Chronic Kidney Diseases, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
What is being tested?: ESRD education + conservative kidney management and ACP education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 24 Oct 2021to 14 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR < 30 ml/min/1.73m2)
Age 65 years or greater or frail
self-reported Black or White race

Who cannot join

History of dementia
History of legal blindness
Listed for kidney transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Read the detailed description

This intervention will be randomized among patients with advanced chronic kidney disease.

Conditions: Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
Being tested: ESRD education + conservative kidney management and ACP education
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESRD education + conservative kidney management and ACP educationOther
Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers

Study groups in NCT03229811
Study group	Role	What they receive
Standard pre-dialysis education	No intervention	Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation
ESRD education + ACP	Active comparator	Standard ESRD education + conservative kidney management and advance care planning education Receives: Other: ESRD education + conservative kidney management and ACP education

What is being measured

The primary outcome is the main question the study is designed to answer.

Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)
Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning
Measured: Pre-intervention and Day 1 post-intervention
Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)
Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning
Measured: Immediate post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 202114 Dec 2021

First posted26 Jul 2017
Study start24 Oct 2021
Primary completion14 Dec 2021
Study completion14 Dec 2021

Why it stopped: The PI left academic practice

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advance Care PlanningStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Masking: Single blind
Who is masked: Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03229811
Sponsor's protocol ID: 831500
Status last verified: Jan 2025
First submitted: 21 Jul 2017
Last updated: 31 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stallings TL, Temel JS, Klaiman TA, Paasche-Orlow MK, Alegria M, O'Hare A, O'Connor N, Dember LM, Halpern SD, Eneanya ND. Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e042620. doi: 10.1136/bmjopen-2020-042620.
PubMed 33619188

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program
ClinicalTrials.gov ID: NCT03229811
Acronym / sponsor ID: 831500
Conditions: Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management
Study type: Interventional
Recruitment status: TerminatedReason stopped: The PI left academic practice
Enrolment: 4 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 24 Oct 2021 (actual)
Primary completion: 14 Dec 2021 (actual)
Study completion: 14 Dec 2021 (actual)
First posted: 26 Jul 2017 (actual)
Results: Posted 31 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This intervention will be randomized among patients with advanced chronic kidney disease.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Comprehensive pre-dialysis program incorporating conservative and advance care planning education

Arm	Type	Receives
Standard pre-dialysis education	No intervention	–Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation
ESRD education + ACP	Active comparator	Other: ESRD education + conservative kidney management and ACP educationStandard ESRD education + conservative kidney management and advance care planning education

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR < 30 ml/min/1.73m2)
Age 65 years or greater or frail
self-reported Black or White race

Key exclusion criteria (3 listed)

History of dementia
History of legal blindness
Listed for kidney transplantation

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
ESRD education + conservative kidney management and ACP educationTargeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers	Other	ESRD education + ACP

Primary outcome

Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)
Time frame: Pre-intervention and Day 1 post-intervention
Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning
Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)
Time frame: Immediate post-intervention
Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning

Results and safety

Results posted to the registry on 31 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Pre-dialysis Education	0	0
ESRD Education + ACP	4	4

Primary outcome: Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)

Time frame: Pre-intervention and Day 1 post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Standard Pre-dialysis Education n = 0	ESRD Education + ACP n = 4
Value	–	5.75 (3.60)

Population analysed: No participants were randomized to standard education

Primary outcome: Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)

Time frame: Immediate post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Standard Pre-dialysis Education n = 0	ESRD Education + ACP n = 3
Value	–	8.67 (0.58)

Population analysed: No participants were randomized to standard education. One enrolled participant did not complete the post-knowledge questionnaire

Adverse events

Time frame: Through study completion, an average of 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Pre-dialysis Education	0 of 0	0 of 0	0
ESRD Education + ACP	0 of 4 (0%)	0 of 4 (0%)	0

Limitations and caveats (from the sponsor): This trial was terminated early leading to a small number of participants who where analyzed. Data should be interpreted cautiously given this caveat.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33619188Stallings TL, Temel JS, Klaiman TA, Paasche-Orlow MK, Alegria M, O'Hare A, O'Connor N, Dember LM, Halpern SD, Eneanya ND. Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e042620. doi: 10.1136/bmjopen-2020-042620.
Individual participant dataSharing planned: No

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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?

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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention) (time frame: Pre-intervention and Day 1 post-intervention). The study lists 2 primary outcomes in all. 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 NCT03229811, 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 31 Jan 2025.