Impact of CAMP in an Ambulatory Renal Clinic

Chronic Kidney Disease Clinical Trial

— CAMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00599365
• Other study ID #: H45161-31657-01
• Secondary ID: T0986
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2008
• Last updated: February 14, 2008
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2007
• Source: San Francisco Veterans Administration Medical Center
• Contact: Jenin Lee, Pharm.D
• Phone: (415) 221-4810
• Email: Jenin.Lee[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	VA Medical Center San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
San Francisco Veterans Administration Medical Center	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. — View 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. — View 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. — View 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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197. — View Citation

Dezii CM. Medication noncompliance: what is the problem? Manag Care. 2000 Sep;9(9 Suppl):7-12. — View 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. Epub 2006 May 1. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2008;(2):CD000011. — View 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. Review. — View 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. Epub 2006 Nov 13. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Reddy SS, Holley JL. Management of the pregnant chronic dialysis patient. Adv Chronic Kidney Dis. 2007 Apr;14(2):146-55. Review. — View 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. Erratum in: Endocr Pract. 2008 Sep;14(6):802-3. multiple author names added. — View Citation

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

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No