Chronic Kidney DiseaseACRinCKDNCT00688285
Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients
A study testing automated clinical alerts and provider education in people with Chronic Kidney Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
To determine whether the use of educational sessions and computerized clinical reminders can improve primary care doctors' delivery of care to CKD patients compared to educational sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD patients 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?
- automated clinical alerts and provider education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2009
- 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
- For PCPs: all GIM attending physicians with a weekly continuity clinic.
- For patients: >= 18 years-old with an eGFR<45ml/min/1.73m2 being seen in the UPMC GIM clinic by a faculty member during the 10-month intervention period
Who cannot join
- for PCPs: imminent plans to leave the department
- patients with a renal transplant, on any form of dialysis, or with a previous nephrology evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
To determine whether the use of educational sessions and computerized clinical reminders can improve primary care doctors' delivery of care to CKD patients compared to educational sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD patients
Read the detailed description
Literature supports that most chronic kidney disease (CKD) patients are cared for by primary care physicians (PCP) without the help of a kidney specialist. Many of these patients fail to achieve targeted outcomes and late referral to a nephrologist has been associated with an increased risk of death. Automated computerized clinical reminders have been shown to improve physician compliance with recommended guidelines in other settings.
Aims: To determine if clinical reminders can help PCPs decrease the rate of late referrals, improve urine albumin checks in CKD patients
Design: prospective randomized controlled, single-blinded study with additional historical control
Methods: Two 20-minute teaching sessions aimed at all GIM PCPs in the UPMC clinic followed by randomization of the eligible GIM providers to receive automated clinical reminders (CR) for their CKD stage 3b-5 patients versus routine care.
Outcomes: Using a database search, individuals with an eGFR<45ml/min/1.73m2 (not seen by a nephrologist) will have data collected on: PCP referral to a nephrologist, urinary albumin (or protein) quantification in the past year, PCP recognition of patients with eGFR<45ml/min, ACE/ARB usage.
- Conditions
- Chronic Kidney Disease
- Being tested
- automated clinical alerts, provider education
- Keywords
- chronic kidney disease, clinical alerts, late referral, electronic medical record, Computerized clinical decision support systems (CDSS)
- 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.
automated clinical alertsOther
automated clinical alerts in the electronic medical record
provider educationOther
PCP education session on CKD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | education and automated clinical alerts Receives: Other: automated clinical alerts; Other: provider education |
| 2 | Active comparator | education session alone Receives: Other: provider education |
What is being measured
The primary outcome is the main question the study is designed to answer.
referral to a nephrologist
Referral to a nephrologist within the 12 months following decision support system activation.
Measured: 12 months
Secondary outcomes (2)
Use of ACE/ARB
Active use of ACE/ARB at the end of the 12 month period following decision support system activation.
Measured: 12 months
Annual ACR or PCR check
ACR or PCR within 12months of the decision support system activation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Khaled Abdel-Kader, MD, Principal investigator, University of PittsburghMark Unruh, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688285
- Sponsor's protocol ID
- PRO07110299
- Acronym
- ACRinCKD
- Status last verified
- Mar 2011
- First submitted
- 28 May 2008
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdel-Kader K, Fischer GS, Li J, Moore CG, Hess R, Unruh ML. Automated clinical reminders for primary care providers in the care of CKD: a small cluster-randomized controlled trial. Am J Kidney Dis. 2011 Dec;58(6):894-902. doi: 10.1053/j.ajkd.2011.08.028. Epub 2011 Oct 7.
PubMed 21982456
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT00688285
- Acronym / sponsor ID
- ACRinCKD / PRO07110299
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, clinical alerts, late referral, electronic medical record, Computerized clinical decision support systems (CDSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Jun 2008 (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.
To determine whether the use of educational sessions and computerized clinical reminders can improve primary care doctors' delivery of care to CKD patients compared to educational sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD patients
Detailed description
Literature supports that most chronic kidney disease (CKD) patients are cared for by primary care physicians (PCP) without the help of a kidney specialist. Many of these patients fail to achieve targeted outcomes and late referral to a nephrologist has been associated with an increased risk of death. Automated computerized clinical reminders have been shown to improve physician compliance with recommended guidelines in other settings.
Aims: To determine if clinical reminders can help PCPs decrease the rate of late referrals, improve urine albumin checks in CKD patients
Design: prospective randomized controlled, single-blinded study with additional historical control
Methods: Two 20-minute teaching sessions aimed at all GIM PCPs in the UPMC clinic followed by randomization of the eligible GIM providers to receive automated clinical reminders (CR) for their CKD stage 3b-5 patients versus routine care.
Outcomes: Using a database search, individuals with an eGFR<45ml/min/1.73m2 (not seen by a nephrologist) will have data collected on: PCP referral to a nephrologist, urinary albumin (or protein) quantification in the past year, PCP recognition of patients with eGFR<45ml/min, ACE/ARB usage.
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 |
|---|---|---|
| 1 | Active comparator | Other: automated clinical alerts, Other: provider educationeducation and automated clinical alerts |
| 2 | Active comparator | Other: provider educationeducation session alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For PCPs: all GIM attending physicians with a weekly continuity clinic.
- For patients: >= 18 years-old with an eGFR<45ml/min/1.73m2 being seen in the UPMC GIM clinic by a faculty member during the 10-month intervention period
Key exclusion criteria (2 listed)
- for PCPs: imminent plans to leave the department
- patients with a renal transplant, on any form of dialysis, or with a previous nephrology evaluation.
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 |
|---|---|---|
| automated clinical alertsautomated clinical alerts in the electronic medical record | Other | 1 |
| provider educationPCP education session on CKD | Other | 1, 2 |
Primary outcome
referral to a nephrologist
Time frame: 12 months
Referral to a nephrologist within the 12 months following decision support system activation.
2 secondary outcomes
Use of ACE/ARB
Time frame: 12 months
Annual ACR or PCR check
Time frame: 12 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 25 Mar 2011.
- Derived from this study: PubMed 21982456Abdel-Kader K, Fischer GS, Li J, Moore CG, Hess R, Unruh ML. Automated clinical reminders for primary care providers in the care of CKD: a small cluster-randomized controlled trial. Am J Kidney Dis. 2011 Dec;58(6):894-902. doi: 10.1053/j.ajkd.2011.08.028. Epub 2011 Oct 7.
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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.
Khaled Abdel-Kader, MD principal investigator
University of Pittsburgh
Mark Unruh, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated clinical alerts and provider education in people with Chronic Kidney Disease, run by University of Pittsburgh 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 2 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 25 Mar 2011. 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?
referral to a nephrologist (time frame: 12 months). 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 NCT00688285, 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 25 Mar 2011.