Directly Observed Therapy And Maximizing Adherence

Alisha Blair, Nurse Consultant

Heartland National TB Center

December 10th, 2009

Directly Observed Therapy and Maximizing Adherence

Objectives• Define DOT and Explain Why We Use This Method

– DOT Do’s and Don’t– Advantages and Disadvantages of DOT

• Discuss the Role of the DOT Provider – Responsibilities– Expanded Role

• Identify Barriers that make Adherence to DOT Difficult– Cultural and Social– Patient

• Adherence– Discuss Court Ordered Treatment – Indications

• Review Cases

Objectives

• Discuss the Goals of DOT– incentives and Enablers

– Importance of Treatment Adherence

• Importance and Implications for TB Treatment Adherence– Drug Resistance– Treatment Failure/Relapse– Reduced Public Health Threat– Economic Burden– Impact of Co-Morbid Conditions

What is DOT ????

• DOT is an acronym for Directly

Observed Therapy

• It is a strategy devised to

assure TB patients adhere to

and complete treatment

• Observation of Medication

Administration- They swallow,

you watch!

Why DOT???

• It’s the most Effective Strategy for ensuring TB Treatment completion

• Reduces risk of developing drug resistance, relapse or reactivation

• Patient becomes non-infectious sooner

• Associated with Better Treatment completion Rates and Outcomes

• It helps solve problems that might interrupt treatment

• Allows the health care worker monitor the patient regularly for side effects

and response to therapy

• 2003 CDC/ATS/ISDA Guidelines Standard of Care

DOT Is Not!!!

• DOD

– Dropped Off at the Door

• SOT

– Self Observed Therapy

• FOT

– Family Observed Therapy

DOT Don’ts– leaving TB medications with the patient to

self-administer except as prescribed by the physician for weekends or holidays

– … leaving TB medications at the patient’s home when the patient is not present

– … dispensing TB medications and “verifying” ingestion/adherence by performing pill counts

– … permitting medical professionals to self-administer their TB medications

Advantages and Disadvantages of DOT Advantages• It ensures that the patient

completes an adequate regimen • It lets the health care worker

monitor the patient regularly for side effects and response to therapy

• It helps the health care worker solve problems that might interrupt treatment

• By ensuring the patient takes every dose of medicine, it helps the patient become noninfectious sooner

Disadvantages

•It is time consuming

•It is labor intensive

•It can be insulting to some

patients

•It can imply that the patient is

incapable or irresponsible

•It can be perceived as

demeaning or punitive

Who May Provide Dot

• Trained TB Clinic or Health Department staff– Nurses, outreach workers, other health care providers

• Trained staff of other health care facilities• Just because they are medical professional does not mean they

are familiar with the principles and requirements for DOT

• Other• Trained School Nurses, Occupational Health Nurses

DOT Worker Responsibilities

• Verify prescribed TB Medication– Against TB 400 A/B– Original Orders

• Deliver Medication• Assess for Drug Toxicity

– Question, Listen, Observe

• Observe Patient Swallowing Medications• Document Visit• Report Possible Drug Toxicity or Other Concerns

The Expanded Role of The DOT Worker

• Foreign Language Skills

– Many DOT Workers Serve as Interpreters

• Patient Advocate

• Link Between Patient and Other Case Management

Team Members

Promoting DOT Adherence

• Treatment of Tuberculosis, American Thoracic Society, CDC and Infectious Disease Society of America, 2003

– “… any public health program or private provider ( or both)

undertaking to treat a patient with tuberculosis is assuming a

public health function that includes not only prescribing an

appropriate regimen but also ensuring adherence to the regimen

until treatment is completed”

Social Barriers that Affect DOT Adherence

• Drug Addictions– Competing priority of obtaining drugs vs. being available to

receive DOT

• Employment– Patient may work in another city and can’t make it to the clinic

for DOT

• Mental Illness– Patient can’t comprehend the disease and the need for

medications– Denial

Knocking Down Social Barriers

• Be Familiar with Alcohol and drug treatment Centers in your area

• Call other HD to ask for assistance with DOT if your patient is in their area

• Assess for mental health issues early and give appropriate referrals

Cultural Barriers that Affect DOT Adherence

• Limited or No English

– Trained interpreters should be available • Ensures patient is receiving the correct information• Allows patient to communicate accurately with provider

• Immigration Status– Non-Residents – Migrant Farm Workers

• Reluctant to undertake activities that might draw attention to themselves

Addressing Cultural Issues

• Be Familiar with Agencies within the

Community that offer Interpreter Services

• Utilize the Language Line

• Assure Patients that No reports from the

clinic will be made to INS

• Be Honest

– Builds Rapport

Predicting Adherence

• A Patient’s Adherence with an anti-TB drug Treatment Regimen is Impossible to Predict

• Adherence is NOT Associated with– Age– Sex– Race– Education– Occupation– Socioeconomic status

The Non-Adherent Patient

• Non –Adherence can be caused by

many reasons

• A Patient that is Non-Adherent to DOT

may be….

– Sick for longer Period of Time

– Spread the Disease to Others

– Develop and spread drug-resistant TB

– Die as the result of interrupted treatment

Common Causes For Non-Adherence

• Social and Cultural Beliefs• Competing Priorities

– Education– Employment

• Patient No Longer Feels Sick• Mental Capacity• Lack of Motivation• Poor Relationships with Healthcare Workers• Control Issues

Tried Everything• Centers for Disease Control and Prevention

“individuals have the right to ignore a doctor's advice or refuse

treatment if they wish. However, persons with infectious TB may

lose that right if health officials believe these persons risk infecting

others by not taking their prescribed medicine. Patients who are

unwilling or unable to adhere to treatment may be required to do

so by law or may be quarantined or isolated until noninfectious.”

• Health care workers should• notify the appropriate supervisory clinical and management staff when

patients are non-adherent

• Determine why the patient is non-adherent and begin strategies that will help the patient finish treatment before legal measures are taken

Quarantine• When All Else Fails

– TB control programs should not begin procedures for confining patients to a treatment facility until after the patient has shown that he or she is unable or unwilling to follow a treatment

• Involuntary confinement or isolation for inpatient treatment should be viewed as the last resort.

• Criteria for Determining the Need for Involuntary Confinement – Laboratory results (acid-fast bacilli smears and cultures) – Clinical signs and symptoms of infectious TB – An abnormal chest radiograph, especially if cavities are present – A history of non-adherence (not caused by factors outside patient's control)

– The opportunity to infect others

Case Study 1 You are assigned to deliver DOT to Mrs. Wilson, a 76-

year-old woman who lives alone in the house she and her husband bought many years ago. Mrs. Wilson was recently released from the hospital. Upon discharge from the hospital, she received education about TB and about the need to take medications until she completes treatment. She was told that she would be started on DOT and a health care worker would visit her at her home to help her take her medication. Mrs. Wilson is elated to have some company. She happily offers you cookies and wants to "talk awhile" before she takes her medication.

• What are the tasks you complete when you deliver DOT to Mrs. Wilson?

Observation• Check for side effects.

– Before the Medications are Given– Ask Mrs. Wilson if she is having any problems with the

medications. – Educate About Symptoms that may Indicated an Adverse

Reaction– If Adverse Reaction Symptoms are Present, do not give

medications– Contact the Supervisor– Arrange and Appointment for the Patient

• Verify the medication.– Each time DOT is delivered,– Verify that the Correct Drugs and Dosages are delivered to Mrs.

Wilson– If this cannot be confirmed, the drugs should not be given. – Contac the supervisor

Administration and Documentation• Watch Mrs. Wilson take the pills

– Medication should not be left for Mrs. Wilson to take on her own.

– The health care worker or Mrs. Wilson should get a glass of water or

other beverage before she is given the pills.

– The health care worker should watch Mrs. Wilson continuously from the

time each pill is given to the time she swallows it.

• Document the visit

– The health care worker should document each visit with Mrs. Wilson

– Indicate whether or not the medication was given

– Document Follow up plans in meds not given

Case Study 2

• Nick is a 27-year-old single unemployed male. He has been in and out of rehabilitation clinics for crack use. He picks up odd jobs in the warehouses and diners on the waterfront. He lives in a single room occupancy hotel. Four weeks ago he was brought by the police to the emergency room of General Hospital for treatment of stab wounds to the right arm resulting from a drug deal gone bad.

Continued….

• Upon admission he was intoxicated, appeared poorly nourished and underweight, and had a productive cough.

• His smears were positive for AFB and he was started on appropriate therapy. He remained in the hospital for 5 days.

• Against medical advice, Nick then insisted on leaving the hospital. On the day of discharge, the infection control nurse telephoned a report to the health department, and instructed Nick to go to the health department the next morning for evaluation and a supply of medicine.

Non-Adherent Nick

• He failed to keep his appointment. The next week a health care worker was assigned to locate Nick and persuade him to come to the clinic. The health care worker found him lying on a park bench near the hotel where he lives. The health care worker convinced Nick to go to the clinic for follow-up tests. At the clinic, Nick reluctantly agrees to take his medication, although he does not want DOT. He says he is not a "baby" and can take the medication on his own.

• How would the health care worker help Nick adhere to his treatment regimen?

• What can the health care worker say about DOT to convince Nick of its importance

Assessment and Education• It is important that we ask Nick what he believes about

TB disease and treatment– Nick doesn't seem to understand the importance of finishing

treatment. Therefore, adherence may be very difficult. • Educate Nick about TB and its treatment

– As part of patient education, Nick should be told that some people have trouble staying on the medication schedule

– Help Nick find ways to identify and deal with potential adherence problems.

• Nick is more likely to be adherent if he helps make the decisions and chooses the solutions

• Nick may be more likely to follow the treatment plan if he understands his illness and the benefits of treatment.

• Offer Incentives and/or Enablers to help Nick Adhere to Treatment.

Patient Education and Rapport Building

• Explain the benefits of DOT to Nick and to stress the fact that DOT is not punitive.

• Explain that DOT is more than watching Nick swallow each pill.

• DOT Will– Help him keep appointments – Provide education when needed

• Point out that DOT will help the health care worker monitor Nick for any side effects and help him complete an adequate regimen

The Goal of DOT

• To Ensure that Clients with Active Tuberculosis receive and Adequately Complete their Treatment

• Minimize the Risk of Spreading the Disease to Others

• Reduce the Risk of Developing Drug-resistant TB

Ensure Clients Receive and Complete Adequate Treatment

• Ensure Clients are Receiving the Correct Doses of Medication– Monitor weight as doses are calculated according to body weight– Incorrect Doses May not be Effective

• Ensure the Client Swallows the Medication • Follow up on Missed DOT Appointments

– Early detection of adherence problems

• Monitor Adverse Reactions• Perform Dose Counts Monthly

– Helps Determine Therapy Completion date and gives information about adherence

DOT and Infection Control

• DOT ensures clients are receiving medications and these patients become non-infectious sooner– Reduces the Risk of Infecting

Others

• DOT Allows the DOT worker to observe client and ensure adherence to infection control measures

Reduce the Risk for Acquiring Drug Resistance

• Provide medications as ordered• Do not allow family members to provide medications• Encourage Clients to Report Side Effects or Adverse

Reactions Immediately– Side effects can discourage a client from being compliant with

treatment

• Always Observe the Client Swallowing the Medication– Do not leave medication at the client’s door step– DOT is not a drop off service

Accomplishing the Goal with Non-Adherent Patients

• Incentives– Rewards for desired behavior

• Enablers– Remove barriers from willing but unable patients

• Both must be tailored to the individual!

BRIBARY DOES WORK!!

Offer Incentives

• Interventions to motivate

the patient, tailored to the

patient wishes and needs

– Incentives work for both

young and old

– Food, Snacks, Gift Cards,

Bus Passes, Clothing

Identify Enablers

• Interventions that Assist the patient complete Therapy– Child Care– Adjustment of Clinic Hours– Appointment Reminders– Appropriate Referrals– Clinic Personnel who speak the languages of the populations

served

• Remember Both Incentives and Enablers must be Tailored to the Patient in Order to be Effective

Importance and Implications of Treatment Adherence

• Reduces the Risk of Developing Drug Resistance– Sporadic Treatment coupled with non-compliance fosters Drug

Resistant TB

• Reduces the risk of Treatment Failure and Relapse– DOT and proper treatment adherence is associated with fewer

rates of relapse and/or reactivation– DOT allows the identification of problems early

• Reduces the threat to Public Health– Person adherent to DOT are usually infectious for shorter

periods of time

Improved Health and Outcomes and Reduced Economic Impact

• No Quarantine

– Adherence daunts the need for Court-Ordered Treatment

Management

• Improves Individual Health Outcomes

– Patient Health Improves and the patient Feels better earlier

• Reduces the Economic Impact

– DOT and the adherence to DOT reduces the cost of treating TB

– Drug Sensitive TB can be treated intermittently by DOT which is

cost effective

Impact of Co-Morbidities• Reduces the impact of co-morbidities i.e. surgical

Interventions and Hospitalization

– DOT benefits the patient not only from a TB Treatment

Standpoint but it also allows the Case Management team to

ensure co-morbid conditions are not exacerbated by

Tuberculosis

– DOT ensures patients are receiving medications and these

patients tend to feel better sooner, negating the need for ED

visits for exacerbation of the disease and possible surgical

intervention

Pulling It All Together• DOT

– strategy devised to assure TB patients adhere to and complete

treatment

– Observation of Medication Administration- They swallow, you watch!

– DOT is not a Milk Man service so medication should not be dropped of at the door step

• Why DOT – It’s the most Effective Strategy for ensuring TB Treatment completion

– Reduces risk of developing drug resistance, relapse or reactivation

Pulling It All Together• The Role of the DOT Provider

– The DOT provider should assess the patient, administer and supervise medication swallowing and document

– Deliver medications as scheduled and report adverse reactions immediately

• Dot Providers– Trained TB Clinic or Health Department staff

• Promoting Adherence– There are many barriers that patients face that foster Non-

adherence to DOT and anti-TB treatment• Social • Cultural

– Identify these factors and offer incentives and/or enablers to maximize treatment adherence

Pulling It All Together• No way to predict adherence

– However assess patient’s current situation to determine possible problems that may hinder adherence

– Assessment should be ongoing throughout treatment

• Court Ordered Treatment– After all else fails consideration for court ordered management should

be the last resort

• Criteria for Determining the Need for Court Ordered Confinement– Laboratory results (acid-fast bacilli smears and cultures) – Clinical signs and symptoms of infectious TB – An abnormal chest radiograph, especially if cavities are present – A history of non-adherence (not caused by factors outside

patient's control) – The opportunity to infect others

Pulling It Together• Incentives and Enablers

– Movie Tickets, Food Coupons, Gift cards, Bus Passes– Motivation to complete treatment– Tailor to Patient’s Needs

• Importance of DOT and Adherence to Treatment– Reduces the Risk of Treatment Failure– Reduces the rate of Relapse/Reactivation– Lowers Economic Burden– Reduces Complications from Co-Morbid Conditions

“DOT succeeds for one reason … DOT makes the health care system, not the

patient, responsible for achieving a cure”

Special ThanksDawn Farrell, RN, San Antonio

Jane Moore, RN, Wisconsin