search
Back to results

Impact of CAMP in an Ambulatory Renal Clinic (CAMP)

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacy care arm
Sponsored by
San Francisco Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring adherence, pharmacist intervention, persistence, renal clinic, pill count

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Medical Center San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmacy Care arm

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2008
Last Updated
February 14, 2008
Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT00599365
Brief Title
Impact of CAMP in an Ambulatory Renal Clinic
Acronym
CAMP
Official Title
Impact of a Pharmacist's Collaborative Management, Adherence,and Medication Education Program (CAMP) in an Ambulatory Renal Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
adherence, pharmacist intervention, persistence, renal clinic, pill count

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacy Care arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmacy care arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenin Lee, Pharm.D
Phone
(415) 221-4810
Ext
3261
Email
Jenin.Lee@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Nelson Chee, Pharm.D
Phone
(415) 221-4810
Ext
3491
Email
Nelson.Chee2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Chee, Pharm.D
Organizational Affiliation
VA Medical Center San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelson Chee, Pharm.D
First Name & Middle Initial & Last Name & Degree
Jenin Lee, Pharm.D
First Name & Middle Initial & Last Name & Degree
Audrey Lee, Pharm.D
First Name & Middle Initial & Last Name & Degree
Kristen Johansen, MD
First Name & Middle Initial & Last Name & Degree
Philip Chiao, Pharm.D
First Name & Middle Initial & Last Name & Degree
David Lovett, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10075613
Citation
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
Results Reference
background
PubMed Identifier
16620194
Citation
Chen RA, Scott S, Mattern WD, Mohini R, Nissenson AR. The case for disease management in chronic kidney disease. Dis Manag. 2006 Apr;9(2):86-92. doi: 10.1089/dis.2006.9.86.
Results Reference
background
PubMed Identifier
11904577
Citation
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
Results Reference
background
PubMed Identifier
16235271
Citation
Haynes RB, Yao X, Degani A, Kripalani S, Garg A, McDonald HP. Interventions to enhance medication adherence. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000011. doi: 10.1002/14651858.CD000011.pub2.
Results Reference
background
PubMed Identifier
17389285
Citation
Kripalani S, Yao X, Haynes RB. Interventions to enhance medication adherence in chronic medical conditions: a systematic review. Arch Intern Med. 2007 Mar 26;167(6):540-50. doi: 10.1001/archinte.167.6.540.
Results Reference
background
PubMed Identifier
11729418
Citation
Dezii CM. Medication noncompliance: what is the problem? Manag Care. 2000 Sep;9(9 Suppl):7-12. No abstract available.
Results Reference
background
PubMed Identifier
12597603
Citation
Loghman-Adham M. Medication noncompliance in patients with chronic disease: issues in dialysis and renal transplantation. Am J Manag Care. 2003 Feb;9(2):155-71.
Results Reference
background
PubMed Identifier
17395117
Citation
Reddy SS, Holley JL. Management of the pregnant chronic dialysis patient. Adv Chronic Kidney Dis. 2007 Apr;14(2):146-55. doi: 10.1053/j.ackd.2007.01.005.
Results Reference
background
PubMed Identifier
17101639
Citation
Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.
Results Reference
background
PubMed Identifier
17502632
Citation
Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.
Results Reference
background
PubMed Identifier
12148711
Citation
Chisholm MA, Mulloy LL, Jagadeesan M, Martin BC, DiPiro JT. Effect of clinical pharmacy services on the blood pressure of African-American renal transplant patients. Ethn Dis. 2002 Summer;12(3):392-7.
Results Reference
background
PubMed Identifier
17268940
Citation
Allenet B, Chen C, Romanet T, Vialtel P, Calop J. Assessing a pharmacist-run anaemia educational programme for patients with chronic renal insufficiency. Pharm World Sci. 2007 Feb;29(1):7-11. doi: 10.1007/s11096-005-4800-4.
Results Reference
background
PubMed Identifier
12748199
Citation
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.
Results Reference
background
PubMed Identifier
17613449
Citation
Rodbard HW, Blonde L, Braithwaite SS, Brett EM, Cobin RH, Handelsman Y, Hellman R, Jellinger PS, Jovanovic LG, Levy P, Mechanick JI, Zangeneh F; AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007 May-Jun;13 Suppl 1:1-68. doi: 10.4158/EP.13.S1.1. No abstract available. Erratum In: Endocr Pract. 2008 Sep;14(6):802-3. multiple author names added.
Results Reference
background
PubMed Identifier
16651464
Citation
Halpern MT, Khan ZM, Schmier JK, Burnier M, Caro JJ, Cramer J, Daley WL, Gurwitz J, Hollenberg NK. Recommendations for evaluating compliance and persistence with hypertension therapy using retrospective data. Hypertension. 2006 Jun;47(6):1039-48. doi: 10.1161/01.HYP.0000222373.59104.3d. Epub 2006 May 1. No abstract available.
Results Reference
background
PubMed Identifier
16044982
Citation
Sikka R, Xia F, Aubert RE. Estimating medication persistency using administrative claims data. Am J Manag Care. 2005 Jul;11(7):449-57.
Results Reference
background
PubMed Identifier
17192377
Citation
American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.
Results Reference
background

Learn more about this trial

Impact of CAMP in an Ambulatory Renal Clinic

We'll reach out to this number within 24 hrs