CONNECTICUT DEPARTMENT OF PUBLIC HEALTH HEALTH CARE AND SUPPORT SERVICES HIV MEDICATION ADHERENCE PROGRAM PROTOCOL

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1 CONNECTICUT DEPARTMENT OF PUBLIC HEALTH HEALTH CARE AND SUPPORT SERVICES HIV MEDICATION ADHERENCE PROGRAM PROTOCOL Revised July 2013

2 HIV MEDICATION ADHERENCE PROGRAM PROGRAM OVERVIEW People living with HIV/AIDS (PLWHA) are living longer and healthier lives due to the advent of highly active antiretroviral therapy (HAART). When taken as prescribed, these medications can lower the HIV viral load and increase the CD4 count which positively impacts their quality of life. To be effective, this therapy requires strict adherence, which means that PLWHA must take their medications correctly 95% of the time. When not taken as prescribed the effectiveness of the medication regimen is hampered and resistance to the medications may occur. Taking these medications can be difficult due to many factors such as: debilitating side effects, difficulties encountered with the number of pills, and inconvenient times medications need to be taken. In addition many PLWHA have co-morbidities such as mental health issues, substance abuse, and co-infection with Hepatitis. Barriers to adherence can include homelessness and other housing issues, lack of transportation, lack of access to medical care, poverty, and competing life issues. Most health providers who treat PLWHA recognize the importance of providing their HIV clients with medication adherence guidance. However their interventions are often limited due to the time constraints of the medical visit. Dedicated staff is needed to provide comprehensive assessments, assist clients to overcome barriers to adherence, and monitor strategies to help clients to adhere to their medication and treatment regimens. ELIGIBILITY REQUIREMENTS Eligibility for services shall be limited to Connecticut residents living with HIV/AIDS who are contemplating taking or are currently taking HIV medication and need assistance with adherence treatment, coping with side effects from the medications, and/or need education on their treatment regimen. There is no financial eligibility requirement for adherence counseling and health education. There is a financial eligibility of 300% FPL for support services (adherence devices, nutritional supplements). Services provided should be made in conjunction with the client s medical provider(s) and medical case manager (MCM) as much as possible. Services must be provided as a payer of last resort. HIV MEDICATION ADHERENCE PROGRAM STRUCTURE AND PERSONNEL The structure of the HIV Medication Adherence Programs is a medical/psychosocial model staffed by licensed medical personnel: Physician s Assistant (PA), Advanced Practice Registered Nurse (APRN), Registered Nurse (RN), or Licensed Practical Nurse (LPN) who provide more than a one-time intervention. The program must sustain the capacity to conduct ongoing monitoring of the client s ability to adhere to their HIV medication and treatment regimen. 2

3 Medication adherence services may be provided in medical and/or community based settings. Medication adherence providers must be willing to meet the client outside of the office and be able to provide services to clients in the clients home or other locations. SCOPE OF SERVICES TO BE PROVIDED The services to be provided must be delivered in the context of assisting a client to adhere to an HIV medication regimen. The services shall include, but are not limited to: 1. Provision of client centered HIV medication and treatment adherence counseling by licensed professional staff which includes: a. Initial and ongoing, at least every six (6) months, assessment of client s motivation, strengths, weaknesses for medication adherence and understanding of HIV disease. b. Initial and ongoing, at least every six (6) months, assessment of client s psychosocial situation and identification of any barriers to medication/treatment adherence. c. Initial and ongoing, at least every six (6) months, assessment of client s medical, substance abuse, and mental health status relative to HIV medication/treatment adherence. d. Provision of health education as needed. e. Provision of referrals as needed. 2. Provision of a client centered care plan by licensed professional staff which includes: a. Realistic and measurable HIV medication adherence goals. b. Monitoring the client s progress in meeting the goals of the plan in the client record. c. Development and monitoring of strategies used to improve adherence which are documented in the client record. d. Collaboration with client s providers, including other members of the health team to obtain necessary support for maximizing adherence to HIV medication/treatment regimens (e.g. MCM for support services, Connecticut AIDS Drug Assistance Program (CADAP), medical providers, mental health providers, substance abuse providers, etc.). 3. Client s progress in meeting medication adherence goals including the use of adherence tools shall be documented at least monthly in the client record in the progress notes and at least every six months in the care plan. 4. Adherence support devices/supplies shall be available to Medication Adherence Programs through a Department of Public Health (DPH) subcontractor as funding permits. Any adherence support devices/supplies above and beyond the supply at the DPH subcontractor shall have DPH approval prior to purchase. 3

4 HIV MEDICATION ADHERENCE PROGRAM STAFF ROLES and RESPONSIBILITIES Staff hired by the agency shall: Adhere to the DPH HIV Medication Adherence Program Protocol, set up and maintain client records as per DPH requirements, install and utilize CAREWare as the data collection and reporting system, submit all financial, programmatic and progress reports as contractually required, and be available for a minimum of three site visits per year as conducted by the assigned Health Care and Support Services (HCSS) Contract Manager and/or Nurse Consultant. Comply with the State and Federal Confidentiality Laws and be in compliance with the Health Insurance Portability and Accountability Act (HIPAA). Have knowledge of HIV/AIDS; maintain their licensure, and work within the scope of standards and practice of care as determined by their level of licensure. Demonstrate the ability to provide culturally competent services for HIV positive individuals; develop knowledge of community resources; be willing to travel and conduct home and/or off site visits. Have good oral and written communication skills and good organizational skills. Maintain a professional relationship with their clients. Coordinate referrals and track linkages and outcomes of clients to medical care and support services to ensure access to and retention in medical care as evidenced by an appropriate documentation in database and progress notes. Attendance at four of the six bi-monthly HIV Medication Adherence Program meetings is required. May teach clients how to fill their medication pillboxes and may fill client pillboxes with confirmation of the current medications from the medical record in hospital settings and with confirmation of the current medications from the medical provider in non-clinical settings. ADMINISTRATION The agency shall require and maintain a current copy of the HIV MAP Staff license from the CT DPH. All contracted agencies under the MAP shall have a client record system that collects and maintains information about client demographics, assessments, care plans, services provided, client response to services, updates, treatment goals, etc., that conforms to the information required by DPH. 4

5 Contractors shall maintain updated client records including, but not limited to Consent, Release of Information, CAREWare user share forms, Grievance Policy Forms, Intake and Medical Assessments, Care Plans, HIV status documentation, Viral Load (VL), CD4 counts, Primary Care Physician information, list of Medications including Antiretroviral Medications (ARVs), Verification of current medications from the medical provider if filling pillboxes, Progress Notes, Case Conferencing, CAREWare Client Report and Encounter Reports, and other documents as required by DPH. Contractors are required to collect and report client level data and certain Performance Measures, as determined by DPH, which are included in CAREWare on a regular, ongoing basis and submit required documentation to Health Resources and Services Administration (HRSA) and DPH. This database information shall include, but is not limited to: VL, CD4 count, PCP prophylaxis treatment, last two Primary Care Visits (at least three months apart), List of ARVs, ARVs if pregnant, HIV Risk Counseling, Hepatitis B Vaccination, Hepatitis B Screening, Hepatitis C Screening, Syphilis Screening, and TB Screening. Client records and contents shall be protected within the parameters of State and Federal laws and regulations. Record retention expectation is seven years. The agency shall provide administrative and clinical supervision for the HIV medication adherence provider. As of July 1, 2011 a Medical Doctor, Physician s Assistant, or Advanced Practice Registered Nurse who specializes in HIV/AIDS care shall provide the clinical supervision. The clinical supervisor will provide clinical guidance, education, and expertise regarding HIV disease management, complications of HIV infection, co-morbidities, interpretation of diagnostic testing, medications, side effects, and any other relevant medical issues. The overall goal is to assist the medication adherence provider to enhance/improve medication adherence for their clients. OUTCOMES AND MEASUREMENTS 1) Documentation of stable or decreased HIV Viral Load 2) Documentation of stable or increased CD4 count 3) Documentation of barriers to adherence that were overcome 4) Documentation of decreased number of medication doses missed (selfreport) REQUIRED REPORTING TO DEPARTMENT OF PUBLIC HEALTH Contractors shall ensure that the data to complete the Ryan White Service Report (RSR) is contained in the CAREWare database preparatory to submission of this report by DPH to HRSA according to timelines established by DPH and HRSA. Contractors shall submit Quarterly Reports that include, but are not limited to: Quarterly MAP Report Cover Page I. Financial Expenditure Report II. Program Narrative Report (typed) 5

6 III. Line List of Unduplicated Clients Year to Date IV. CAREWare Part B MAP Services Listing V. CAREWare Multiple Performance Measures Report (completed by Supervisor) VI. Internal MAP Audit Reports five (completed by Supervisor) VII. Services Requested Received/Denied VIII. MAP Gift Card Logs IX. Copy of Client Satisfaction Survey(s), Suggestion Box Comments, Interviews, etc. and Result Summary - (Period 4/Final Report only) REPORTING PERIOD Jul Sep Oct Dec Jan Mar Apr Jun REPORTS DUE Nov 1 st Feb 1 st May 1 st Sep 1 st QUALITY ASSURANCE MONITORING The contractor shall maintain policies and procedures as required by the department to monitor and evaluate program activities and outcomes as well as to require maintenance of quality of services provided. Each agency must have a Quality Management Plan which is submitted annually to the DPH HCSS Nurse Consultant by June 30 th of each year. The contractor shall develop an internal information management system to collect and review data related to the numbers and type of services accessed by clients utilizing services. The contractor shall perform quality assurance activities using the DPH HCSS MAP Internal Audit form on five (5) clients a quarter in order to assure completion of information, documentation, proper eligibility determinations for support services (medication adherence devices, nutritional supplements) and general orderliness of records. This outcome is to be reported as part of the quarterly progress report. Of those persons determined to be eligible, at least 90 percent shall receive needed program services. Quality Assurance Audit will be conducted three times per year by the Department of Public Health. Client data and outcome indicators shall be reported quarterly to DPH per contract. Sub-contractors must send their reports to the lead contract agency. A narrative program report should accompany the data report, each quarter, which includes, at a minimum, the following information: A) Include a sum of the client data B) Outreach activities C) Strengths and barriers of program to date 6

7 QUALITY ASSURANCE SITE VISIT DOCUMENTATION and FORMS Client Record The appropriate forms are being used with proper documentation; the forms are organized and secured in the body of the client s record. The records are kept confidential and secured in locking cabinets. 1. Consent Form Consent forms are signed, dated and are current (within 12 months or specifically stated on form). 2. CAREWare Client Consent and User Agreement Forms Forms are initialed, signed, dated and are current (within 12 months or specifically stated on form). 3. Authorization to Obtain and/or Disclose Protected Health Information (PHI) Forms are initialed, signed, dated and are current (within 12 months or specifically stated on form). 4. Grievance Policy Form Forms are signed and dated. 5. Adherence Assessment Forms An assessment of the client s adherence status should be conducted initially and at a minimum of every six months. 6. HIV Medication Adherence Care Plan and Adherence Devices An HIV Medication Adherence Care Plan should be developed within ten (10) business days after the assessments with proper documentation including documentation of adherence devices offered/given as appropriate. The Care Plan should be completed every six (6) months, signed and dated by the Client and the MAP Nurse. The client s signature confirms that the client understands the plan to include goals and interventions (if the client does not sign the Care Plan, document and date reason in the client s Progress Note). 7. Progress Notes A progress note must be completed by the MAP Nurse on a client at least monthly, which includes strategies used to increase/sustain adherence, medical progress, and referrals to other necessary support services for adherence, etc. (client goals will be monitored from the care plans). Circumstances that necessitate a deviation from this time frame should be documented in the progress note of the client record (e.g., client is unable to be contacted by phone or by mail, no permanent housing, relocation, incarceration, etc.). 7

8 The MAP Nurse will document the progress on meeting the goals addressed in the Care Plan in the progress note. The MAP Nurse will document efforts to contact the client as needed (e.g., to update client information, reassess care plan, assess completion of referral, etc.). The MAP Nurse making the progress note entry must sign using his/her full legal name, title and date in accordance with the nursing standards of care or agency protocol. The MAP Nurse should not leave blank spaces within the progress notes. 8. CAREWare Client Report & Client Encounter Report The reports must be updated at least every six months or upon significant change in client status. Client Record and CAREWare 1. HIV/AIDS Diagnosis/Documentation Acceptable sources for HIV documentation are one of the following: HIV Test Results: A copy of a seropositive blood test for antibodies to HIV: ELISA (Enzyme Linked Immunosorbent Assay) confirmed by western blot assay with the client s name on the test report. Documentation from a medical provider: A signed letter or medical history, treatment plan, or progress note from a licensed provider with identified agency/medical provider logo stating that the client has HIV/AIDS. 2. CD4 and Viral Load Documentation of lab results every six months should be filed in the client s record and CAREWare. Attempts to obtain the lab results should be documented if outdated (more than six months old). 3. PCP Prophylaxis Client on PCP prophylaxis if CD4 is <200, or if ordered by client s health care provider and is documentation in the client s record and CAREWare. 4. Medical Care Provider and Dates of the Last 2 Visits (at least 3 months apart) Documentation of the client s Medical Care Provider and the dates of two last visits in the record and CAREWare. 5. Medications Including (ARVs) and Medication Orders Documentation of medications including ARV medications prescribed with dosages in client record and CAREWare (if possible). 8

9 6. ARVs if client is pregnant 7. Hepatitis B Screening (once) Documentation of Hepatitis B screening. 8. Hepatitis C Screening (once) Documentation of Hepatitis C screening. 9. Syphilis Screening (12 months) Documentation of syphilis screening. 10. Tuberculosis Screening (once) Documentation of TB screening. 11. Hepatitis B Vaccinations (series of three) Documentation of vaccinations or immune status of client. 12. Case Conferencing, Referrals and Outcomes of Referrals Case conferencing, client referrals and outcomes of referrals shall be documented at least every three (3) months 13. HIV Risk Counseling (12 months) Documentation of HIV risk counseling. QUALITY IMPROVEMENTS Medication Adherence Program staff shall: 1) Attend Adherence Meetings to improve programs goals, develop an internal process for evaluating the effectiveness of their programs and report suggestions for improvement at regularly scheduled Adherence Meetings. 2) Attend Adherence Meetings for continuing education, information updates, networking, and case conferencing. 3) Document the progress towards meeting the Quality Management/Quality Improvement goals from Quality Management Plan in the Program Narrative starting January 1, REFERENCES U.S. Department of Health and Human Services - Health and Resources Service Administration (HRSA), HIV/AIDS Bureau (HAB) Performance Measures, National Quality Center (NQC), Connecticut Department of Public Health (DPH) TB, HIV, STD & Viral Hepatitis Section, Health Care and Support Services Unit (HCSS) P\adhere protocol.doc 12/05, Revised: 10/10jmb/dg; 10/11jmb/dg; 7/12jmb/dg 9

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