Ub Research Project for Cdhs Curriculum Development

UB RESEARCH PROJECT FOR CDHS CURRICULUM DEVELOPMENT

CDHS, College Relations Group (BuffaloState College Research Foundation) StateUniversity of New York at Buffalo, School of Pharmacy and Pharmaceutical Sciences Partnership

Work Plan Agreement

September 20, 2004 to August 15, 2005

Meg Brin, Child Welfare Administrative Director

Michelle Barbarossa, Child Welfare Trainer

Chelly Coyle, Independent Living Trainer

RC01.01 Independent Living Network Training and Technical Assistance

Student Name:Lisa Rubin, Pharm.D. Student

Primary Contact: Linda Catanzaro, Pharm.D., Clinical Assistant Professor

University at Buffalo, Department of Pharmacy Practice

FacultyLinda Catanzaro, Pharm.D., Clinical Assistant Professor

Consultants:University at Buffalo, Department of Pharmacy Practice

Naomi Boston, Pharm.D., HIV/ID Specialty Resident,

University at Buffalo, Department of Pharmacy Practice

Judianne Slish, Pharm.D., Clinical Assistant Professor

University at Buffalo, Department of Pharmacy Practice

Project SiteBabette Sullivan, RN

Consultants:PACT Clinic, Women and Children’s Hospital of Buffalo

Robert Welliver, MD

PACT Clinic, Women and Children’s Hospital of Buffalo

ResearchProject: Examining Adherence Barriers in Pediatric and Adolescent HIV Patients – Year Two

Project Overview:

Adherence to treatment is a critical component of HIV therapy for all age groups. Studies have shown that at least 95% adherence is necessary to prevent the development of viral resistance to currently available medications (1). Optimal medication regimens consist of at least three antiretroviral agents (2) (3). Complex dosing schedules as well as varying food requirements and side effect profiles present significant obstacles to achieving the required level of adherence (4).

Previous studies in adult patients have identified several predictors of poor adherence: depression, drug and/or alcohol use, history of non-adherence, medication side effects, and lack of education about treatment (5) (6). While these predictors represent significant barriers, they are not insurmountable. They can be overcome with interventions and services provided through a multidisciplinary team approach that involves healthcare providers, patients, and their caregivers (7) (8) (9). Medication adherence in pediatric HIV/AIDS patients involves the additional challenge of caregiver responsibility along with developmental changes that continue to evolve and must be addressed as the child grows.

An HIV Pharmacotherapy Consult Service has been developed by the University at Buffalo School of Pharmacy and Pharmaceutical Sciences to provide services in medication management at the Women and Children’s Hospital of Buffalo (WCHOB). This includes the operation of an HIV Adherence Clinic for patients at the hospital’s Parents and Children Together (PACT) clinic for one half-day session on a bi-weekly basis. Doctor of Pharmacy (Pharm.D.) students and residents work alongside an HIV Pharmaceutical Care Specialist (Pharm.D.) to educate patients, caregivers, families and medical providers with regard to optimizing drug therapy, measuring patients’ medication adherence on a routine basis and monitoring, minimizing and/or preventing drug-related side effects and potential drug interactions.

An interdisciplinary approach is used and involves the incorporation of nursing staff, counselors, social workers, and nutritionists along with the pharmacists and physicians. Monthly case conferences are held for the purpose of reviewing individual cases and discussing current concerns with the goal of optimizing therapy to meet each patient’s specific medical and social needs.

In addition to the on-site services, medical providers are able to request consult services at any time by phone or via the HIV ePharmcotherapy Network at .

During the first year of this research project a total of 25 patients, ranging in age from one to 20 participated in the adherence program and were evaluated according to the objectives listed below. Current literature was also reviewed and used to generate a written report outlining background information on HIV infection and it’s treatment as well as case examples of interventions implemented to optimize therapy for patients with documented adherence barriers. Additionally, a presentation was provided for CDHS staff and a training manual was developed for use by case manager trainers in the Child Welfare Division.

During the second year of this project, the patient population will be expanded to include a larger contingency of adolescent patients. The current standard of care that exists in the PACT Clinic at WCHOB will be incorporated into the hospital’s Adolescent Medicine division. All of the above activities will be provided for these patients, some of whom have been transitioned from the PACT Clinic but most of whom have been infected with HIV primarily through sexual contact as teenagers rather than perinatal transmission. This collaboration will result in the addition of approximately ten adolescent patients to the current patient population.

Rationale:

While studies have evaluated adherence barriers in adults and provided valuable information for healthcare providers and social services personnel, there is limited data on the impact of these barriers in the adolescent HIV patient population and even less in pediatric patients. Conceivably, the psychosocial barriers including depression and substance abuse, would have an indirect yet still significant effect on medication adherence in pediatric patients when they are present in the lives of their caregivers. Whether the HIV-status of the parent or caregiver is an independent risk factor for predicting a child’s adherence, has yet to be formally studied as well.

A better understanding of the impact of these issues and possible interventions that can be implemented to successfully manage them would benefit healthcare providers, social services personnel, and caregivers of pediatric HIV/AIDS patients. The HIV Adherence Clinic and Pharmacotherapy Consult Service that is already in operation at the PACT Clinic in Buffalo provides an excellent environment to evaluate this patient population and the impact of interdisciplinary interventions that can be implemented to help improve medication adherence and overall patient care.

Purpose:

HIV Pharmaceutical Care Specialist, physicians, nursing staff, and social workers will have a more thorough understanding of the specific adherence barriers that are most prevalent in their pediatric/adolescent patient population as well as specific interventions that can be most effective in overcoming them. Patient caregivers will, in turn, be provided with more specific education on how to manage these issues in their role.

Application:

CC02 Child Welfare/Child Protective Services Outcome Based Training

RC01Independent Living Network Training and Technical Assistance

Objectives:

Continue to monitor patients that were followed during initial year of project.
Gather demographic data for all new PACT Clinic patients and Adolescent Medicine patients with HIV/AIDS, including the nature of the relationship between the parent(s)/caregiver(s) and the child(ren)/adolescents (i.e. biological, foster care, kinship foster care or adoption).
Update demographic data for current PACT Clinic patients already included in first-year of project.
Review/update social history of each patient, including any substance use.
Review/update medical history of each patient with regard to depression status.
Review/update medication adherence history of each patient.
Determine most common adherence barriers in this population.
Track interventions (adherence counseling and tools, home visits, psychological consults, etc.).
Investigate which barriers and which interventions have the biggest impact on adherence.
Evaluate, when possible, substance abuse and depression in the caregiver as potential adherence barriers.
Explore the impact of HIV+ vs. HIV- status of parent/caregiver on adherence.
Investigate relationship of adherence to placement of patients in foster care (i.e. kinship vs. non-kinship placement).

References:

Paterson D, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infections. Ann Intern Med 2000; 133:21-30.

Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents, March 23, 2004.

National Institutes of Health Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, January 20, 2004.

Gallant J, Block D. Adherence to antiretroviral regimens in HIV-infected patients: results of a survey among physicians and patients. J Int Assoc Physicians AIDS Care 1998; 4:32-5.

Kleeberger CA, Phair JP, Strathdee SA, Detels R, Kingsley L, Jacobson LP. Determinants of heterogeneous adherence to HIV-antiretroviral therapies in the multicenter AIDS cohort study. J Acquir Immune Defic Syndr 2001; 26:82-92.

Gordillo V, del Amo J, Soriano V, Gonzalez-Lahoz J. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS 1999; 13:1763-9.

Ickovics JR, Meade CS. Adherence to antiretroviral therapy among patients with HIV: a critical link between behavioral and biomedical sciences. JAIDS 2002; 31:98-102.

Tuldra A, Wu AW. Interventions to improve adherence to antiretroviral therapy. JAIDS 2002; 31:S154-7.

Esch LD, Klem K, Kuhmann L, Hewitt RG, Morse GD.Intensive Adherence Interventions Improve Virologic Response to Antiretroviral Therapy (ART) in Treatment Naïve Patients. Presented at the 14th International AIDS Conference, Barcelona, Spain, July 7-12, 2002 (Poster MoPeB3301).