HypertensionCDSSR18NCT02925962
Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
A study testing Clinical Decision Support System (CDSS) and Clinic Decision Sup System + Pharmacist in people with Hypertension and Renal Insufficiency, Chronic, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Renal Insufficiency, Chronic
- What is being tested?
- Clinical Decision Support System (CDSS) and Clinic Decision Sup System + Pharmacist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 30 Jun 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have at least two outpatient, documented eGFRcreat values 30- 59 ml/min/1.72m2 that are at least ≥3 months apart
- At least one of these measurements should be within 12 months.
- Patients have seen their primary care physician at least one time within the previous 18 months
- Patient's primary care providers agree to participate
Who cannot join
- Patients actively and recently seen by nephrology clinic (at least once in the past 12 months)
- Patients with a diagnosis of end stage renal disease
- Persons aged >80
- Persons with New York Heart Association (NYHA) class III or IV heart failure, known ejection fraction < 25%, or documented allergy to ace/arb.
- Patients on dialysis, kidney transplant recipients and pregnant women
- Patients with prevalent dementia, impaired cognition or severe mental illness; expected life expectancy < 6 months.
- There will also be a category where the physician can opt out for specific patients in their panel due to not believing this person should be included in the study for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Division of General Internal Medicine
San Francisco, California, 94115
About this study
Official title: A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. The first intervention will evaluate the efficacy of an automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker test ordering, guideline implementation and BP management, compared with usual care, among patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.
Read the detailed description
Setting:
The investigators will conduct this study within the three General Internal Medicine (GIM) practices at UCSF. These include general internal medicine PCPs who practice primary care. This trial is specifically designed to work within the framework of the existing infrastructure of these practices.
Randomization:
The unit for randomization will be the PCP (MD and NPs with their own panel of patients); the investigators plan to include up to 105 PCPs.
Training and Pre-Trial Preparation:
Prior to the beginning of this trial, all eligible providers at the UCSF GIM practice will be informed of this trial by the PI via email, attached with consent information, at which time they will be sent a link to information about the Kidney Disease Improving Global Outcomes (KDIGO) guidelines, and they will have the opportunity to opt-out of the trial. PCP randomization will be performed by the study coordinator using an automated procedure. The PCPs randomized to the intervention arms (CDSS and CDSS PLUS) will have the option to view a brief training video designed by study PIs and IT experts on the automated CKD CDSS.
Blinding:
The analysts will remain blinded throughout the trial and data analyses.
Intervention Details (CKD CDSS):
The CKD CDSS has been developed by the study PIs and IT experts, and refined using physician feedback. While the tool will be automated as much as possible using the electronic medical record, provider decision making will be required at all diagnostic or treatment steps in the CDSS.
The study MD will order all of the triple marker CKD tests not yet done(creatinine, urine microalbumin, cystatin C). Once the tests are ordered, patients will proceed to the laboratory as they normally would in clinical practice. The EHR will be programmed to return the results to the PCP's clinical results folder in APeX, and to a study inbox monitored by the study MDs. Participating PCPs will be advised about tests being ordered along with a list of their eligible patients when sent the opt out letter prior to being randomized.
Best Practice Alert (BPA), Smart Set: The CDSS will allow a "second-chance" for test ordering if the tests are not completed prior to an enrolled patient encounter (for PCPs in the CDSS or CDSS Plus arms), by automatically delivering a reminder message embedded in the visit encounter as part of a best practice alert (BPA) indicating that the triple marker tests have been ordered but not completed for this patient. If the tests have been completed at the time of the visit, the BPA will give CKD staging based on the triple marker for the individual patient and have a button to click to open a smart smart-set tailored to that specific patient. The smart-set will cover the orders and recommendations as indicated for that patient: Blood pressure target, use of ACEI/ARB class of medications, potassium management, use of statin medications, pre-populated referral to nephrology when indicated, patient educational material on NSAIDS and CKD in general to populate the After Visit Summary.
CDSS PLUS: The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings. For PCPs in the CDSS PLUS intervention arm, the study will provide cards identifying the pharmacist on the clinical team. During the visit in which the CDSS launches, the PCPs can let the patient know that a pharmacist, who is part of the clinical team, will be calling to follow-up, and he/she can hand these cards out to eligible patients. In addition, the CDSS smart set for these patients will give information about the pharmacist that can populate the After Visit Summary. This warm hand-off will allow the patient to be aware of the reason for the pharmacist's post-visit call. For patients active on MyChart, the pharmacist will use MyChart to set up a good time to call the patient within two weeks. If the patient does not use MyChart, the pharmacist will attempt to call and leave messages for the patient. On the phone call, the pharmacist will discuss and collect data on the patient's understanding of CKD, conduct a medication review and adherence assessment, ask about home BP checks, and discuss the importance of NSAID avoidance.
All calls will be documented in APeX to allow the entire clinical team to follow the patient's care and route messages to the PCP and team RN as necessary. A second call from the pharmacist will only be triggered if the patient is non-adherent and makes an active plan for adherence requiring a follow-up call to check-in on that plan, or if the patient requests an additional follow-up call.
- Conditions
- Hypertension, Renal Insufficiency, Chronic
- Being tested
- Clinical Decision Support System (CDSS), Clinic Decision Sup System + Pharmacist
- Medical subject headings
- Hypertension, 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 System (CDSS)Other
A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.
Clinic Decision Sup System + PharmacistOther
Also called CDSS Plus, Clinical Decision Support System + Pharmacist
Includes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support System (CDSS) | Experimental | PCPs get a notice the CKD Clinical Decision Support System (CDSS) is available.
CDSS overview:
* The study MDs order CKD triple marker tests
* Patients will go to the lab as per usual clinical care
* Lab results are returned to PCPs clinical results folder as per usual clinical workflow with information about CKD and link to KDIGO guidelines
* Results will also be sent to the Study MD's for monitoring
* At the patient's next visit, if the labs are completed, the full CDSS launches for the PCP
* If the labs are not completed by the next visit, a Best Practice Alert (BPA) will launch for the PCP notifying them that the labs have been ordered, but the patient hasn't done them yet Receives: Other: Clinical Decision Support System (CDSS) |
| Clinic Decision Sup System + Pharmacist | Experimental | The Clinical Decision Support System + Pharmacist follow-up call extends beyond the CDSS alone.
CDSS Plus overview:
* At the visit in which the CDSS launches, the PCP will hand a study card with pharmacist information to their patient notifying them that a pharmacist will be calling to follow-up after the visit
* The pharmacist will use MyChart and/or phone calls to schedule a follow-up call within two weeks of the visit
* On the follow-up phone call, the pharmacist will discuss understanding of CKD, medication review and adherence assessment, home BP checks, and the importance of NSAID avoidance
* A second follow-up call will only be scheduled if the patient is non-adherent with their medications and makes an active plan for adherence with the pharmacist, or if the patient requests an additional call from the pharmacist Receives: Other: Clinic Decision Sup System + Pharmacist |
| Usual Care | No intervention | Patients continue to receive usual care by their provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure from enrollment
Clinical Outcome: The primary clinical outcome of the trial is change in blood pressure (mmHg) from enrollment to the end of the follow up period as a continuous outcome, ascertained from the electronic medical record. BP measures from the clinical record will be ascertained in no more than quarterly intervals in the primary care setting to avoid bias by ascertainment. Investigators will also consider the dichotomous clinical outcome "achieved sustained BP control", defined as BP < 140/90 mmHg in ≥ two consecutive visits during the trial.
Measured: Investigators will follow patients up to 2 years after measures
Secondary outcomes (3)
Feasibility
Investigators will assess provider awareness of CKD, defined as percent appropriate inclusion of CKD in the problem list (dichotomous outcome).
Measured: Investigators will follow patients up to 2 years after measures
Processes of Care
Investigators will also measure use of ACEI/ARB among persons with albuminuria, measured as the proportion (percent) of persons on these medications at the end of the study period, compared to enrollment. Medication prescription will be ascertained by percent with an electronic record of a new order or modification during the study period, not including refills. Other process outcomes relate to feasibility and the ability to implement the CDSS protocol. These include proportion in the intervention arms with completion of albuminuria and cystatin C testing.
Measured: Investigators will follow patients up to 2 years after measures
CKD and NSAID avoidance Knowledge
Patient-centered outcomes: Investigators will evaluate CKD and NSAID avoidance knowledge (proportion with correct answers), using structured telephone interviews, and comparing patients from the three study arms.
Measured: Investigators will interview each participant 2 weeks after their primary care visit or clinical pharmacist phone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start14 Aug 2017
- Primary completion4 Oct 2018
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925962
- Sponsor's protocol ID
- CP2016R18
- Acronym
- CDSSR18
- Status last verified
- Aug 2020
- First submitted
- 30 Sep 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan for monitoring data and safety: A recommendation to order a creatinine and potassium level following initiation or up-titration of ace/arb will be incorporated in the algorithm in the result note. A 24/7 line to a nephrology answering service will be available to participating Primary Care Providers (PCPs) in the case of critical results; for non-critical study-related questions, participating PCPs can contact the study nephrologist via staff messaging in APeX. If a patient is found to have eGFR \< 30 ml/min/1.73m2, investigators will recommend nephrology referral for pre-dialysis care.
Publications
Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24.
PubMed 15563563Peralta CA, Shlipak MG, Judd S, Cushman M, McClellan W, Zakai NA, Safford MM, Zhang X, Muntner P, Warnock D. Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011 Apr 20;305(15):1545-52. doi: 10.1001/jama.2011.468. Epub 2011 Apr 11.
PubMed 21482744Shlipak MG, Coresh J, Gansevoort RT. Cystatin C versus creatinine for kidney function-based risk. N Engl J Med. 2013 Dec 19;369(25):2459. doi: 10.1056/NEJMc1312801. No abstract available.
PubMed 24350959Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
PubMed 23732715Peralta CA, Livaudais-Toman J, Stebbins M, Lo L, Robinson A, Pathak S, Scherzer R, Karliner LS. Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial. Am J Kidney Dis. 2020 Nov;76(5):636-644. doi: 10.1053/j.ajkd.2020.05.013. Epub 2020 Jul 22.
PubMed 32682696Khoong EC, Karliner L, Lo L, Stebbins M, Robinson A, Pathak S, Santoyo-Olsson J, Scherzer R, Peralta CA. A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design, Rationale, and Implementation Experience. JMIR Res Protoc. 2019 Jun 7;8(6):e14022. doi: 10.2196/14022.
PubMed 31199334
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
- ClinicalTrials.gov ID
- NCT02925962
- Acronym / sponsor ID
- CDSSR18 / CP2016R18
- Conditions
- Hypertension, Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Oct 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.
The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. The first intervention will evaluate the efficacy of an automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker test ordering, guideline implementation and BP management, compared with usual care, among patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.
Detailed description
Setting:
The investigators will conduct this study within the three General Internal Medicine (GIM) practices at UCSF. These include general internal medicine PCPs who practice primary care. This trial is specifically designed to work within the framework of the existing infrastructure of these practices.
Randomization:
The unit for randomization will be the PCP (MD and NPs with their own panel of patients); the investigators plan to include up to 105 PCPs.
Training and Pre-Trial Preparation:
Prior to the beginning of this trial, all eligible providers at the UCSF GIM practice will be informed of this trial by the PI via email, attached with consent information, at which time they will be sent a link to information about the Kidney Disease Improving Global Outcomes (KDIGO) guidelines, and they will have the opportunity to opt-out of the trial. PCP randomization will be performed by the study coordinator using an automated procedure. The PCPs randomized to the intervention arms (CDSS and CDSS PLUS) will have the option to view a brief training video designed by study PIs and IT experts on the automated CKD CDSS.
Blinding:
The analysts will remain blinded throughout the trial and data analyses.
Intervention Details (CKD CDSS):
The CKD CDSS has been developed by the study PIs and IT experts, and refined using physician feedback. While the tool will be automated as much as possible using the electronic medical record, provider decision making will be required at all diagnostic or treatment steps in the CDSS.
The study MD will order all of the triple marker CKD tests not yet done(creatinine, urine microalbumin, cystatin C). Once the tests are ordered, patients will proceed to the laboratory as they normally would in clinical practice. The EHR will be programmed to return the results to the PCP's clinical results folder in APeX, and to a study inbox monitored by the study MDs. Participating PCPs will be advised about tests being ordered along with a list of their eligible patients when sent the opt out letter prior to being randomized.
Best Practice Alert (BPA), Smart Set: The CDSS will allow a "second-chance" for test ordering if the tests are not completed prior to an enrolled patient encounter (for PCPs in the CDSS or CDSS Plus arms), by automatically delivering a reminder message embedded in the visit encounter as part of a best practice alert (BPA) indicating that the triple marker tests have been ordered but not completed for this patient. If the tests have been completed at the time of the visit, the BPA will give CKD staging based on the triple marker for the individual patient and have a button to click to open a smart smart-set tailored to that specific patient. The smart-set will cover the orders and recommendations as indicated for that patient: Blood pressure target, use of ACEI/ARB class of medications, potassium management, use of statin medications, pre-populated referral to nephrology when indicated, patient educational material on NSAIDS and CKD in general to populate the After Visit Summary.
CDSS PLUS: The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings. For PCPs in the CDSS PLUS intervention arm, the study will provide cards identifying the pharmacist on the clinical team. During the visit in which the CDSS launches, the PCPs can let the patient know that a pharmacist, who is part of the clinical team, will be calling to follow-up, and he/she can hand these cards out to eligible patients. In addition, the CDSS smart set for these patients will give information about the pharmacist that can populate the After Visit Summary. This warm hand-off will allow the patient to be aware of the reason for the pharmacist's post-visit call. For patients active on MyChart, the pharmacist will use MyChart to set up a good time to call the patient within two weeks. If the patient does not use MyChart, the pharmacist will attempt to call and leave messages for the patient. On the phone call, the pharmacist will discuss and collect data on the patient's understanding of CKD, conduct a medication review and adherence assessment, ask about home BP checks, and discuss the importance of NSAID avoidance.
All calls will be documented in APeX to allow the entire clinical team to follow the patient's care and route messages to the PCP and team RN as necessary. A second call from the pharmacist will only be triggered if the patient is non-adherent and makes an active plan for adherence requiring a follow-up call to check-in on that plan, or if the patient requests an additional follow-up call.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support System (CDSS) | Experimental | Other: Clinical Decision Support System (CDSS)PCPs get a notice the CKD Clinical Decision Support System (CDSS) is available. CDSS overview: * The study MDs order CKD triple marker tests * Patients will go to the lab as per usual clinical care * Lab results are returned to PCPs clinical results folder as per usual clinical workflow with information about CKD and link to KDIGO guidelines * Results will also be sent to the Study MD's for monitoring * At the patient's next visit, if the labs are completed, the full CDSS launches for the PCP * If the labs are not completed by the next visit, a Best Practice Alert (BPA) will launch for the PCP notifying them that the labs have been ordered, but the patient hasn't done them yet |
| Clinic Decision Sup System + Pharmacist | Experimental | Other: Clinic Decision Sup System + PharmacistThe Clinical Decision Support System + Pharmacist follow-up call extends beyond the CDSS alone. CDSS Plus overview: * At the visit in which the CDSS launches, the PCP will hand a study card with pharmacist information to their patient notifying them that a pharmacist will be calling to follow-up after the visit * The pharmacist will use MyChart and/or phone calls to schedule a follow-up call within two weeks of the visit * On the follow-up phone call, the pharmacist will discuss understanding of CKD, medication review and adherence assessment, home BP checks, and the importance of NSAID avoidance * A second follow-up call will only be scheduled if the patient is non-adherent with their medications and makes an active plan for adherence with the pharmacist, or if the patient requests an additional call from the pharmacist |
| Usual Care | No intervention | –Patients continue to receive usual care by their provider. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have at least two outpatient, documented eGFRcreat values 30- 59 ml/min/1.72m2 that are at least ≥3 months apart
- At least one of these measurements should be within 12 months.
- Patients have seen their primary care physician at least one time within the previous 18 months
- Patient's primary care providers agree to participate
Key exclusion criteria (7 listed)
- Patients actively and recently seen by nephrology clinic (at least once in the past 12 months)
- Patients with a diagnosis of end stage renal disease
- Persons aged >80
- Persons with New York Heart Association (NYHA) class III or IV heart failure, known ejection fraction < 25%, or documented allergy to ace/arb.
- Patients on dialysis, kidney transplant recipients and pregnant women
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 System (CDSS)A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting. | Other | Clinical Decision Support System (CDSS) |
| Clinic Decision Sup System + PharmacistAlso: CDSS Plus, Clinical Decision Support System + PharmacistIncludes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings. | Other | Clinic Decision Sup System + Pharmacist |
Primary outcome
Change in blood pressure from enrollment
Time frame: Investigators will follow patients up to 2 years after measures
Clinical Outcome: The primary clinical outcome of the trial is change in blood pressure (mmHg) from enrollment to the end of the follow up period as a continuous outcome, ascertained from the electronic medical record. BP measures from the clinical record will be ascertained in no more than quarterly intervals in the primary care setting to avoid bias by ascertainment. Investigators will also consider the dichotomous clinical outcome "achieved sustained BP control", defined as BP < 140/90 mmHg in ≥ two consecutive visits during the trial.
3 secondary outcomes
Feasibility
Time frame: Investigators will follow patients up to 2 years after measures
Processes of Care
Time frame: Investigators will follow patients up to 2 years after measures
CKD and NSAID avoidance Knowledge
Time frame: Investigators will interview each participant 2 weeks after their primary care visit or clinical pharmacist phone call
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 12 Aug 2020.
- Results publication: PubMed 15563563Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24.
- Results publication: PubMed 21482744Peralta CA, Shlipak MG, Judd S, Cushman M, McClellan W, Zakai NA, Safford MM, Zhang X, Muntner P, Warnock D. Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011 Apr 20;305(15):1545-52. doi: 10.1001/jama.2011.468. Epub 2011 Apr 11.
- Results publication: PubMed 24350959Shlipak MG, Coresh J, Gansevoort RT. Cystatin C versus creatinine for kidney function-based risk. N Engl J Med. 2013 Dec 19;369(25):2459. doi: 10.1056/NEJMc1312801. No abstract available.
- Results publication: PubMed 23732715Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
- Derived from this study: PubMed 32682696Peralta CA, Livaudais-Toman J, Stebbins M, Lo L, Robinson A, Pathak S, Scherzer R, Karliner LS. Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial. Am J Kidney Dis. 2020 Nov;76(5):636-644. doi: 10.1053/j.ajkd.2020.05.013. Epub 2020 Jul 22.
- Derived from this study: PubMed 31199334Khoong EC, Karliner L, Lo L, Stebbins M, Robinson A, Pathak S, Santoyo-Olsson J, Scherzer R, Peralta CA. A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design, Rationale, and Implementation Experience. JMIR Res Protoc. 2019 Jun 7;8(6):e14022. doi: 10.2196/14022.
- Individual participant dataSharing planned: No. Plan for monitoring data and safety: A recommendation to order a creatinine and potassium level following initiation or up-titration of ace/arb will be incorporated in the algorithm in the result note. A 24/7 line to a nephrology answering service will be available to participating Primary Care Providers (PCPs) in the case of critical results; for non-critical study-related questions, participating PCPs can contact the study nephrologist via staff messaging in APeX. If a patient is found to have eGFR < 30 ml/min/1.73m2, investigators will recommend nephrology referral for pre-dialysis care.
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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?
A study testing Clinical Decision Support System (CDSS) and Clinic Decision Sup System + Pharmacist in people with Hypertension and Renal Insufficiency, Chronic, run by University of California, San Francisco 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 7 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 12 Aug 2020. 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?
Change in blood pressure from enrollment (time frame: Investigators will follow patients up to 2 years after measures). 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 NCT02925962, which also lists 6 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 12 Aug 2020.