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

NCT01290614 | Completed Phase 4 Results

• 1 other identifier: 10088-H41
• Study Type: interventional
• Target: 2,199
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure (SBP)

  Average SBP for those with a baseline BP \> 130/80

  one year

Secondary Outcomes (1)

• Number of Participants With PTH Measurement During the Study Period

  one year

Study Arms (2)

Pharmacist intervention

EXPERIMENTAL

Other: Pharmacist based QI program

Control - usual care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Pharmacist based QI program OTHER

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.

Pharmacist intervention

Usual Care OTHER

Patients in the control arm will continue to receive "usual care" from their VA providers.

Control - usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

LSCDVAMC

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• 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.

  PMID: 25881226 RESULT

• Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

  PMID: 36472416 DERIVED

Related Links

• Open Access version of manuscript

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paul Drawz, MD
• Organization: University of Minnesota

draw0003@umn.edu

6126255423

Study Officials

• Paul E Drawz, MD, MHS, MS

  LSCDVAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 13, 2015
• Results First Posted: July 13, 2015

Record last verified: 2015-06

Locations

US (1)