Chronic Kidney DiseaseNCT02990897
Pilot Study of Health Information Technology for Chronic Kidney Disease Management
A study testing clinical decision support message in people with Chronic Kidney Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Researchers now know that treating chronic kidney disease (CKD) in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. Computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best… 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?
- clinical decision support message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 14 Jul 2022
- 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
- patients who are 18 years or older
- patients of primary care providers who are included in the study
- patients with CKD (defined as two estimated glomerular filtration rate (GFR) values under 60 mL/min per 1.73 m^2 90 days apart)
Who cannot join
- patients without CKD (defined as two GFR values under 60 mL/min per 1.73 m^2 90 days apart)
- patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore Physicians Group
Danvers, Massachusetts, 01923
About this study
Researchers now know that treating chronic kidney disease (CKD) in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. Computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best treatments. In this project the investigators will test computer reminders in primary care clinics to see if they improve treatment of early chronic kidney disease and to see if it can promote referral to nephrology.
Read the detailed description
The investigators are conducting a randomized trial to determine the effect of a health information technology (HIT) application to calculate risk progression of end stage renal disease (ESRD). The primary outcome is the completion of the necessary tests for the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and primary care provider (PCP) satisfaction. In the analysis, all patients over the age of 18 who have a visit with one of physicians involved in the trial during the intervention period will be eligible and patients with stage 3-5 CKD will be included. Physicians are the subjects in this study, as the intervention is a behavioral intervention for physicians. The physicians' patients will not actively be recruited and will only indirectly be affected by the study. The application creates blocks of patient appointments for each physician and randomly assigns patients to intervention and control arms within these blocks.
- Conditions
- Chronic Kidney Disease
- Being tested
- clinical decision support message
- Keywords
- Medical informatics, Quality of care, Referral
- 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.
clinical decision support messageBehavioural
The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care. |
| Intervention Group | Experimental | Patients with Stage 3,4, or 5 CKD who are randomized to the intervention group will receive care from a physician who has been exposed to the intervention: a clinical decision support message. This clinical decision support message shows the patient's risk of kidney failure over the next 5 years. Receives: Behavioral: clinical decision support message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory tests completed
Dichotomous measure of whether laboratory tests necessary to calculate the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) were resulted in the electronic health record for patients who did not previously have all of these tests done in the prior year.
Measured: 6 months following primary care visit
Secondary outcomes (2)
Urine microalbumin to creatinine ratio test completed
Dichotomous measure of whether urine microalbumin to creatinine ratio test was completed for patients who did not previously have these tests done in the prior year.
Measured: 6 months following primary care visit
Referral of patient from PCP to nephrologist
Dichotomous measure of whether a patient was seen by a nephrologist for patients who did not previously have these tests done in the prior year.
Measured: 6 months following primary care visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completion14 Jul 2022
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 Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lipika Samal, Brigham and Women's Hospital
- Investigators
- Lipika Samal, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990897
- Sponsor's protocol ID
- 0
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2016
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Samal L, D'Amore JD, Gannon MP, Kilgallon JL, Charles JP, Mann DM, Siegel LC, Burdge K, Shaykevich S, Lipsitz S, Waikar SS, Bates DW, Wright A. Impact of Kidney Failure Risk Prediction Clinical Decision Support on Monitoring and Referral in Primary Care Management of CKD: A Randomized Pragmatic Clinical Trial. Kidney Med. 2022 May 28;4(7):100493. doi: 10.1016/j.xkme.2022.100493. eCollection 2022 Jul.
PubMed 35866010
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Health Information Technology for Chronic Kidney Disease Management
- ClinicalTrials.gov ID
- NCT02990897
- Acronym / sponsor ID
- 0
- Conditions
- Chronic Kidney Disease
- Keywords
- Medical informatics, Quality of care, Referral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 13 Dec 2016 (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.
Researchers now know that treating chronic kidney disease (CKD) in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. Computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best treatments. In this project the investigators will test computer reminders in primary care clinics to see if they improve treatment of early chronic kidney disease and to see if it can promote referral to nephrology.
Detailed description
The investigators are conducting a randomized trial to determine the effect of a health information technology (HIT) application to calculate risk progression of end stage renal disease (ESRD). The primary outcome is the completion of the necessary tests for the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and primary care provider (PCP) satisfaction. In the analysis, all patients over the age of 18 who have a visit with one of physicians involved in the trial during the intervention period will be eligible and patients with stage 3-5 CKD will be included. Physicians are the subjects in this study, as the intervention is a behavioral intervention for physicians. The physicians' patients will not actively be recruited and will only indirectly be affected by the study. The application creates blocks of patient appointments for each physician and randomly assigns patients to intervention and control arms within these blocks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care. |
| Intervention Group | Experimental | Behavioral: clinical decision support messagePatients with Stage 3,4, or 5 CKD who are randomized to the intervention group will receive care from a physician who has been exposed to the intervention: a clinical decision support message. This clinical decision support message shows the patient's risk of kidney failure over the next 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who are 18 years or older
- patients of primary care providers who are included in the study
- patients with CKD (defined as two estimated glomerular filtration rate (GFR) values under 60 mL/min per 1.73 m^2 90 days apart)
Key exclusion criteria (2 listed)
- patients without CKD (defined as two GFR values under 60 mL/min per 1.73 m^2 90 days apart)
- patients under the age of 18
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 |
|---|---|---|
| clinical decision support messageThe intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information. | Behavioural | Intervention Group |
Primary outcome
Laboratory tests completed
Time frame: 6 months following primary care visit
Dichotomous measure of whether laboratory tests necessary to calculate the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) were resulted in the electronic health record for patients who did not previously have all of these tests done in the prior year.
2 secondary outcomes
Urine microalbumin to creatinine ratio test completed
Time frame: 6 months following primary care visit
Referral of patient from PCP to nephrologist
Time frame: 6 months following primary care visit
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 3 Aug 2022.
- Derived from this study: PubMed 35866010Samal L, D'Amore JD, Gannon MP, Kilgallon JL, Charles JP, Mann DM, Siegel LC, Burdge K, Shaykevich S, Lipsitz S, Waikar SS, Bates DW, Wright A. Impact of Kidney Failure Risk Prediction Clinical Decision Support on Monitoring and Referral in Primary Care Management of CKD: A Randomized Pragmatic Clinical Trial. Kidney Med. 2022 May 28;4(7):100493. doi: 10.1016/j.xkme.2022.100493. eCollection 2022 Jul.
- 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.
Lipika Samal, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical decision support message in people with Chronic Kidney Disease, run by Brigham and Women's Hospital 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 3 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 3 Aug 2022. 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?
Laboratory tests completed (time frame: 6 months following primary care visit). 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 NCT02990897, 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 3 Aug 2022.