Impact of CAMP in an Ambulatory Renal Clinic

NCT ID: NCT00599365

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

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

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pharmacy care arm

Intervention Type: OTHER

• 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

VA Medical Center, San Francisco

Principal Investigators

Nelson Chee, Pharm.D

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center San Francisco

Locations

VA Medical Center San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jenin Lee, Pharm.D

Role: CONTACT

Jenin.Lee@va.gov

(415) 221-4810 ext. 3261

Nelson Chee, Pharm.D

Role: CONTACT

Nelson.Chee2@va.gov

(415) 221-4810 ext. 3491

References

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.

Reference Type: BACKGROUND

PMID: 10075613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16620194 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11904577 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16235271 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17389285 (View on PubMed)

Dezii CM. Medication noncompliance: what is the problem? Manag Care. 2000 Sep;9(9 Suppl):7-12. No abstract available.

Reference Type: BACKGROUND

PMID: 11729418 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12597603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17395117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17101639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17502632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12148711 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17268940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12748199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17613449 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16651464 (View on PubMed)

Sikka R, Xia F, Aubert RE. Estimating medication persistency using administrative claims data. Am J Manag Care. 2005 Jul;11(7):449-57.

Reference Type: BACKGROUND

PMID: 16044982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17192377 (View on PubMed)

Other Identifiers

T0986

Identifier Type: -

Identifier Source: secondary_id

H45161-31657-01

Identifier Type: -

Identifier Source: org_study_id