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Completed

NCT Number: NCT01767883

Improving Evidence-Based Primary Care for Chronic Kidney Disease

Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary care offices and primary care physicians are generally not familiar with treatment guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated with co-morbidities that make effective treatment difficult due to complexity of care. Availability of Clinical Decision Support (CDS) for CKD may help promote effective, evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality improvement and other interventions such as CDS plus practice facilitation may be needed.

Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice guidelines that PCPs may use to enhance the care they provide to a difficult to manage segment of the healthcare population.

Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model of practice change, versus CDS alone. The study aims to analyze differences in promoting evidence-based care in primary care practices. Thirty-six practices will be recruited for this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration Rate (eGFR) of <60 and >15ml/min/1.73m2 confirmed with repeat testing over three or more months. A process evaluation will be conducted between the CDS practices with facilitation and the CDS only practices to assess clinical outcomes of CKD progression and all-cause mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism starting on 07/01/2011 and ending on 06/30/2016.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Chronic Kidney Insufficiency Chronic Renal Diseases Chronic Renal Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Insufficiency, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Academy of Family Physicians

Leawood, Kansas, 66211, United States

About this study

The proposed trial tests the extent to which CDS plus facilitation promotes evidence-based care and improves the clinical outcomes of reduced disease progression and mortality in primary care practices. We also conduct an observational comparative effectiveness analysis of data from a larger database of electronic medical records in order to identify the most successful components of evidence-based care with respect to disease progression and all-cause mortality.

Specific Aim 1: Conduct a group randomized controlled trial of point-of-care computer decision support plus the full TRANSLATE model of practice change, versus computer decision support alone in promoting evidence-based care in primary care practices for all patients with an eGFR <60 and > 15 ml/min/1.73m2 confirmed with repeat testing over three or more months. (CKD stages 3 and 4) Hypothesis 1.1: CDS practices using the TRANSLATE model will provide a greater degree of evidence-based guideline-concordant care for CKD than CDS only practices.

Specific Aim 2: Conduct an intent-to-treat and process analysis between the CDS practices with facilitation versus the CDS only practices of the clinical outcomes of CKD progression and all-cause mortality.

Hypothesis 2.1: Patients with stage 3 and 4 CKD in facilitated practices will have slower CKD progression than patients in CDS only practices.

Hypothesis 2.2: Patients with stage 3 and 4 CKD in facilitated practices will have significantly lower all-cause mortality than stage 3 and 4 patients in CDS only practices.

Hypothesis 2.3: The process evaluation will determine through qualitative methods the fidelity of the facilitated TRANSLATE program; find the challenges and enablers of the implementation process, the role of facilitation, and the contextual factors that contribute to TRANSLATE decisions and strategies; and translate lessons learned into pragmatic "best practices" for future facilitation and dissemination.

Specific Aim 3: Conduct a cost-effectiveness analysis that will compare the benefit of the intervention of computer decision support alone against the intervention of computer decision support plus TRANSLATE (practice facilitation). Hypothesis 3.1 The intervention of computer decision support plus TRANSLATE is more cost-effectiveness than the intervention of computer decision support alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all individuals whose primary care provider offices participate in the study who is over the age of 18 with a diagnosis of stages 2-4 of CKD and/or diabetes and/or hypertension and/or one eGFR <60 and/or one urine albumin/creatinine ratio >30

Exclusion criteria

  • individual patients whose primary care provider's practice has not signed practice and data use agreements with the AAFP NRN to participate in this practice improvement project at the practice level

Treatment and study plan

Facilitated Clinical Decision Support

Other

The primary care practices in this arm will receive:

  • CKD decision support algorithms added to their Clinical Decision Support
  • System Academic detailing concerning the rationale for the algorithms
  • On-going mentoring and practice facilitation
  • Audit and feedback during quarterly reviews of practice data with the practice facilitator by videoconference.

Other names: Facilitated CDS,, CDS plus facilitation

Clinical Decision Support Only

Other
  • CKD decision support algorithms added to their Clinical Decision Support
  • System Academic detailing concerning the rationale for the algorithms

Other names: CDS Only, "Comparator"

Primary outcomes

  1. Degree of evidence-based guideline-concordant care for CKD

    Time frame: up to 3 years

    Percentage of patients at goal for:

    Control Blood Pressure Control LDL Control HbA1C Use ACE/ARB Eliminate NSAID/Cox-2 use Refer to Nephrologist Eliminate Smoking

Secondary outcomes

  1. CKD Management Process Measures

    Time frame: upt to 3 years

    Percentage of patients who have:

    Diagnosis of CKD Annual Microalbumin/Creatinine Ratio Annual LDL Annual A1c Follow up creatinine measure Follow up ACR measure

  2. Cost of intervention

    Time frame: up to 3 years

    Extra costs of the "Translate CKD" intervention and the control intervention, compared to no intervention. Claims data from Centers for Medicare & Medicaid Services, additional practice and patient costs

  3. All-cause mortality

    Time frame: up to 3 years

    Death data from the CDC National Death Index

Other outcomes

  1. Process evaluation outcomes

    Time frame: Change from Baseline practice performance at 3 years

    Qualitative and descriptive measure of practice performance, physician and staff satisfaction and process changes as obtained through site visit observations, interviews and questionnaires.

Sponsors and collaborators

Lead sponsor

American Academy of Family Physicians

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Kidney Foundation, United States
  • University at Buffalo
  • University of Colorado, Denver

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jan 15, 2013
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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