Chronic Kidney DiseasePREPARE NOWNCT02428569
Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: The PREPARE NOW Study
A study testing PREPARED Decision Support in people with Chronic Kidney Disease, run by Duke University at 1 site in United States.
Trial summary
This study evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- PREPARED Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- English speaking
- Advanced kidney disease defined as an eGFR < 20 mL/min/1.73m2 at their last clinical appointment with their nephrologist
- Have not initiated a Renal Replacement Therapy
Who cannot join
- Cannot speak English
- Have initiated Renal Replacement Therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University / Nephrology Center Of Maryland / Good Samaritan Hospital
Baltimore, Maryland, 21239
About this study
Official title: Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: Partnering to Break the News, Review All Options, Weigh Pros and Cons (PREPARE NOW)
This study evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the educational materials and half will receive usual care from their doctors.
Read the detailed description
The investigators will study the effectiveness of patient educational materials (a book and DVD, called the PREPARED materials) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the PREPARED materials and half will receive usual care from their doctors. PREPARED materials feature patients and their families discussing the pros and cons of different treatment options for kidney failure. The investigators will randomly assign patients already under the care of a nephrologist to receive the video and book or to receive their usual nephrology care. They will measure the degree to which patients in either study arm are prepared for kidney failure treatment at follow up.
- Conditions
- Chronic Kidney Disease
- Being tested
- PREPARED Decision Support
- Keywords
- shared decision making, patient education, decision aids
- 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.
PREPARED Decision SupportBehavioural
The PREPARED DVD presents patient and health care provider testimonials that characterize the pros and cons of different kidney replacement treatment options, including in-center hemodialysis, home hemodialysis, peritoneal dialysis, kidney transplant, and conservative management (i.e., no dialysis or transplant). The PREPARED book reinforces differences between the treatments by showing (in lay language) summaries of scientific evidence on treatment outcomes associated with each kidney replacement option.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants randomized to this arm of the study will receive usual care from their physician. |
| PREPARED Decision Support | Experimental | Participants randomized to this arm of the study will receive the PREPARED educational book and video. Receives: Behavioral: PREPARED Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of self-care dialysis or receipt of transplant
Among the participants initiating renal replacement therapy (RRT) during follow up, the proportion who initiate self-care dialysis (peritoneal dialysis or home hemodialysis) or receive a transplant.
Measured: 90 days after randomization
Use of permanent vascular access
Proportion of patients achieving initiation of RRT with a permanent vascular access.
Measured: 90 days after randomization
Emergent dialysis initiation
Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
Measured: 90 days after randomization
Transplant evaluations, waiting list placement
Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation.
Measured: 90 days after randomization
Blood pressure control at RRT initiation
Proportion of patients achieving blood pressure control (systolic blood pressure <130mmHg and diastolic blood pressure <80mmHg) at each visit prior to RRT initiation or completion of study follow up.
Measured: 90 days after randomization
Anemia management
Proportion of patients with anemia treated to recommended levels (hemoglobin 10g/dl to 12g/dl) at each visit prior to RRT initiation or completion of study follow up.
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Duke 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh E. Boulware, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428569
- Sponsor's protocol ID
- Pro00051812
- Other IDs
- 1R34DK094116-01
- Acronym
- PREPARE NOW
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DePasquale N, Ephraim PL, Ameling J, Lewis-Boyer L, Crews DC, Greer RC, Rabb H, Powe NR, Jaar BG, Gimenez L, Auguste P, Jenckes M, Boulware LE. Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study. BMC Nephrol. 2013 Jan 14;14:9. doi: 10.1186/1471-2369-14-9.
PubMed 23317336Ameling JM, Auguste P, Ephraim PL, Lewis-Boyer L, DePasquale N, Greer RC, Crews DC, Powe NR, Rabb H, Boulware LE. Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions. BMC Med Inform Decis Mak. 2012 Dec 1;12:140. doi: 10.1186/1472-6947-12-140.
PubMed 23198793Sheu J, Ephraim PL, Powe NR, Rabb H, Senga M, Evans KE, Jaar BG, Crews DC, Greer RC, Boulware LE. African American and non-African American patients' and families' decision making about renal replacement therapies. Qual Health Res. 2012 Jul;22(7):997-1006. doi: 10.1177/1049732312443427.
PubMed 22645225
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: Partnering to Break the News, Review All Options, Weigh Pros and Cons (PREPARE NOW)
- ClinicalTrials.gov ID
- NCT02428569
- Acronym / sponsor ID
- PREPARE NOW / Pro00051812
- Conditions
- Chronic Kidney Disease
- Keywords
- shared decision making, patient education, decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Apr 2015 (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 evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the educational materials and half will receive usual care from their doctors.
Detailed description
The investigators will study the effectiveness of patient educational materials (a book and DVD, called the PREPARED materials) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the PREPARED materials and half will receive usual care from their doctors. PREPARED materials feature patients and their families discussing the pros and cons of different treatment options for kidney failure. The investigators will randomly assign patients already under the care of a nephrologist to receive the video and book or to receive their usual nephrology care. They will measure the degree to which patients in either study arm are prepared for kidney failure treatment at follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants randomized to this arm of the study will receive usual care from their physician. |
| PREPARED Decision Support | Experimental | Behavioral: PREPARED Decision SupportParticipants randomized to this arm of the study will receive the PREPARED educational book and video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- English speaking
- Advanced kidney disease defined as an eGFR < 20 mL/min/1.73m2 at their last clinical appointment with their nephrologist
- Have not initiated a Renal Replacement Therapy
Key exclusion criteria (2 listed)
- Cannot speak English
- Have initiated Renal Replacement Therapy
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 |
|---|---|---|
| PREPARED Decision SupportThe PREPARED DVD presents patient and health care provider testimonials that characterize the pros and cons of different kidney replacement treatment options, including in-center hemodialysis, home hemodialysis, peritoneal dialysis, kidney transplant, and conservative management (i.e., no dialysis or transplant). The PREPARED book reinforces differences between the treatments by showing (in lay language) summaries of scientific evidence on treatment outcomes associated with each kidney replacement option. | Behavioural | PREPARED Decision Support |
Primary outcome
Initiation of self-care dialysis or receipt of transplant
Time frame: 90 days after randomization
Among the participants initiating renal replacement therapy (RRT) during follow up, the proportion who initiate self-care dialysis (peritoneal dialysis or home hemodialysis) or receive a transplant.
Use of permanent vascular access
Time frame: 90 days after randomization
Proportion of patients achieving initiation of RRT with a permanent vascular access.
Emergent dialysis initiation
Time frame: 90 days after randomization
Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
Transplant evaluations, waiting list placement
Time frame: 90 days after randomization
Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation.
Blood pressure control at RRT initiation
Time frame: 90 days after randomization
Proportion of patients achieving blood pressure control (systolic blood pressure <130mmHg and diastolic blood pressure <80mmHg) at each visit prior to RRT initiation or completion of study follow up.
Anemia management
Time frame: 90 days after randomization
Proportion of patients with anemia treated to recommended levels (hemoglobin 10g/dl to 12g/dl) at each visit prior to RRT initiation or completion of study follow up.
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 27 Feb 2019.
- Background: PubMed 23317336DePasquale N, Ephraim PL, Ameling J, Lewis-Boyer L, Crews DC, Greer RC, Rabb H, Powe NR, Jaar BG, Gimenez L, Auguste P, Jenckes M, Boulware LE. Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study. BMC Nephrol. 2013 Jan 14;14:9. doi: 10.1186/1471-2369-14-9.
- Background: PubMed 23198793Ameling JM, Auguste P, Ephraim PL, Lewis-Boyer L, DePasquale N, Greer RC, Crews DC, Powe NR, Rabb H, Boulware LE. Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions. BMC Med Inform Decis Mak. 2012 Dec 1;12:140. doi: 10.1186/1472-6947-12-140.
- Background: PubMed 22645225Sheu J, Ephraim PL, Powe NR, Rabb H, Senga M, Evans KE, Jaar BG, Crews DC, Greer RC, Boulware LE. African American and non-African American patients' and families' decision making about renal replacement therapies. Qual Health Res. 2012 Jul;22(7):997-1006. doi: 10.1177/1049732312443427.
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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.
Leigh E. Boulware, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREPARED Decision Support in people with Chronic Kidney Disease, run by Duke 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 4 inclusion and 2 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 27 Feb 2019. 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?
Initiation of self-care dialysis or receipt of transplant (time frame: 90 days after randomization). The study lists 6 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 NCT02428569, which also lists 3 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 27 Feb 2019.