Impact of CAMP in an Ambulatory Renal Clinic (CAMP)

February 14, 2008 updated by: San Francisco Veterans Affairs Medical Center

Impact of a Pharmacist's Collaborative Management, Adherence,and Medication Education Program (CAMP) in an Ambulatory Renal Clinic

The purpose of this study is to see if a pharmacist can help patients understand how he/she should be taking their medications. The study is also being done to see if meeting with the pharmacist can help patients better control chronic kidney disease and the medical problems that can occur.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease (CKD) is a serious condition associated with premature mortality, decrease quality of life, and increase health-care costs. An estimated 19 million Americans (1 in 9 US adults) have non-dialysis dependent CKD (Stages 1-4).1 The health care expenditures for caring for patients with CKD are substantial. According to Centers for Medicare and Medicaid Services (CMS), the estimated annual health cost per patient for managing patients with CKD is markedly higher ($28,000) compared to the costs for caring for diabetic patients ($10,000 per patient) and heart failure patients ($5000 per patient). 2 According to the National Kidney Foundation, as renal function declines, the number of renal complications, notably high blood pressure, anemia, malnutrition, and mineral and bone disorders, increases along with the severity. A large proportion of patients with CKD also develop multiple co-morbidities, particularly hypertension, diabetes, and hyperlipidemia. Fortunately, accumulating evidence indicates that treatment of earlier stages of chronic kidney disease can prevent the development of kidney failure (Stage 5)3. In addition, early prevention of cardiovascular risk factors in patients with CKD may reduce cardiovascular events before and after the onset of kidney failure.3 Because many patients, particularly in the later stages of CKD, have multiple renal complications and chronic co-morbidities, these patients are potentially at high risk of medication non-adherence and non-persistence (defined as premature discontinuation of medication therapy). Studies have demonstrated that patients with chronic diseases typically take only 50% of prescribed doses of medication, leading to increased disease severity, clinic visits, and hospital admissions, resulting in substantial healthcare expenditures.4,5 In the United States alone, the cost of illness, due to non-adherence was estimated to be $170 billion per year.6 In addition, the associated total cost of treating the complications resulting from poor adherence in dialysis and transplant patients exceeds $950 million.7 Potential barriers to medication adherence for patients with chronic diseases include, but are not limited to, complex medication regimens, multiple drug doses, treatment of asymptomatic conditions, and cognitive factors. Although not well-studied in pre-dialysis patients, limited data suggests that important causes of medication non-adherence in chronic dialysis patients include inadequate prescription coverage or high medication costs, lack of transportation, and adverse effects. 8

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • Recruiting
        • VA Medical Center San Francisco
        • Principal Investigator:
          • Nelson Chee, Pharm.D
        • Sub-Investigator:
          • Jenin Lee, Pharm.D
        • Sub-Investigator:
          • Audrey Lee, Pharm.D
        • Sub-Investigator:
          • Kristen Johansen, MD
        • Sub-Investigator:
          • Philip Chiao, Pharm.D
        • Sub-Investigator:
          • David Lovett, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients will be eligible for enrollment if they are > 18 year old men or women receiving care from the VAMCSF Renal Clinic with a documented diagnosis of CKD stage 2-5, and are receiving pharmacological treatment for one or more medical conditions of CKD, including hypertension, diabetes, CKD-mineral and bone disorders, and/or anemia of chronic disease.

Exclusion Criteria:

Patients will be excluded from the study if they obtain medications prescribed for the above medical conditions from a facility outside the VAMCSF, are enrolled in Medi-Set clinic, are kidney transplant patients, are diagnosed with CKD stage 1, require assistance in the administration of their medications (i.e. caregiver), lack adequate transportation to clinic, and/or lack telephone access.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacy Care arm

The pharmacist:

  • will take all the patient's medication bottles, and give medication boxes filled with medications in the order the patient should take them in.
  • will need to obtain a complete list of medications.
  • will teach the patient about the medications.
  • will provide a medication schedule, and other papers about the medications.
  • will count the pills in the medication boxes.
  • will review all the medications with the patient and answer any question.
  • will check to see if the medication is working for the patient.
  • will work with the patient's kidney doctor to adjust medications if needed.
  • will give the medication boxes filled with medications to take home.
Other: Pharmacy care arm
  • The pharmacist will take all your medication bottles, and give you medication boxes filled with your medications in the order you should take them in.
  • You will need to give a complete list of medications to the pharmacist.
  • You will need to describe how you take these medications.
  • The pharmacist will teach you about the medications. This includes side effects, drug interactions, and directions.
  • The pharmacist will give you a medication schedule, and other papers about your medications.
No Intervention: Control

The pharmacist:

  • will obtain a complete list of medications.
  • will count the pills in the patients' medication bottles.
  • will inform patients to take their medications from these bottles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MPR cumulative persistence rates pill counts blood glucose HgbA1c hemoglobin concentration iron ferritin transferrin saturation SBP/DBP corrected calcium phosphorous calcium-phosphorus product uAlb/Cr eGFR.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Nelson Chee, Pharm.D, VA Medical Center San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

February 15, 2008

Last Update Submitted That Met QC Criteria

February 14, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H45161-31657-01
  • T0986

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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