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A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pharmacist based QI program
Usual Care
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • receipt of primary care at a VISN 10 Northeast Ohio CBOC
  • GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and
  • at least one primary care visit in the year prior to study initiation.

Exclusion Criteria:

  • ESRD as defined by chronic renal replacement therapy,
  • receipt of a renal transplant,
  • hospice care, and
  • age greater than 85 years or less than 18 years at the time of study initiation.

Sites / Locations

  • LSCDVAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pharmacist intervention

Control - usual care

Arm Description

Patients assigned to control will continue to receive care from their VA provider.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure (SBP)
Average SBP for those with a baseline BP > 130/80

Secondary Outcome Measures

Number of Participants With PTH Measurement During the Study Period
The primary process outcome was measurement of PTH during the study period.

Full Information

First Posted
February 4, 2011
Last Updated
June 16, 2015
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01290614
Brief Title
A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)
Official Title
A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect. Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.
Detailed Description
Research Plan: The experimental design is a prospective, randomized controlled trial evaluating the impact of a Chronic Care Model (CCM) based quality improvement program on CKD guideline adherence. The intervention will focus on three main goals: 1) reduction of BP to target levels, 2) appropriate monitoring of patients for metabolic complications of CKD, and 3) reduced use of dialysis catheters in patients initiating dialysis. The CKD CCM QI program will include a lecture on CKD guidelines and hypertension to all CBOC providers and a centrally located pharmacist with access to the CKD registry. Methodology: Veterans receive primary care at Community Based Outpatient Centers (CBOCs) throughout Northeast Ohio. Patients with CKD who receive their primary care at a Northeast Ohio CBOC will be eligible for the study. The hypothesis was formulated before data collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist intervention
Arm Type
Experimental
Arm Title
Control - usual care
Arm Type
Active Comparator
Arm Description
Patients assigned to control will continue to receive care from their VA provider.
Intervention Type
Other
Intervention Name(s)
Pharmacist based QI program
Intervention Description
Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients in the control arm will continue to receive "usual care" from their VA providers.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure (SBP)
Description
Average SBP for those with a baseline BP > 130/80
Time Frame
one year
Secondary Outcome Measure Information:
Title
Number of Participants With PTH Measurement During the Study Period
Description
The primary process outcome was measurement of PTH during the study period.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: receipt of primary care at a VISN 10 Northeast Ohio CBOC GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and at least one primary care visit in the year prior to study initiation. Exclusion Criteria: ESRD as defined by chronic renal replacement therapy, receipt of a renal transplant, hospice care, and age greater than 85 years or less than 18 years at the time of study initiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Drawz, MD, MHS, MS
Organizational Affiliation
LSCDVAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSCDVAMC
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25881226
Citation
Cooney D, Moon H, Liu Y, Miller RT, Perzynski A, Watts B, Drawz PE. A pharmacist based intervention to improve the care of patients with CKD: a pragmatic, randomized, controlled trial. BMC Nephrol. 2015 Apr 16;16:56. doi: 10.1186/s12882-015-0052-2.
Results Reference
result
Links:
URL
http://www.biomedcentral.com/1471-2369/16/56
Description
Open Access version of manuscript

Learn more about this trial

A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)

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