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PATIENT AGREEMENT AND INFORMED CONSENT

TESTOSTERONE REPLACEMENT THERAPY (TRT)

The purpose of this Patient Agreement and Informed Consent to Testosterone Replacement Therapy (TRT) (“TRT Consent”) is to inform you about the treatment, medical, or diagnostic procedure that may be recommended by physicians engaged by Broad Health P.A. and Adrian Rawlinson, M.D., P.C. d/b/a Broad Health of California (collectively “Broad Health”) so that you may make the decision of whether or not to undergo the treatment or procedure after knowing the risks and benefits involved. 

•      TRT Treatment; Risks and Benefits.

TRT involves the administration of controlled or scheduled medications regulated by the U.S. Drug Enforcement Administration (DEA) for the treatment of men with symptomatic hypogonadism. A therapeutic testosterone level is individual to each patient. Attaining and sustaining specific levels are impacted by a number of variables such as medical history, age, weight, mental and physical stress, diet, exercise and medications.  After a review of these variables and a thorough evaluation of your symptoms and labs, your Broad Health physician will decide in his or her professional judgement whether TRT is clinically indicated for you.  

Potential Clinical Benefits of TRT:

• Increase in Focus and mental clarity
• Increases sense of emotional well being
• Helps maintain memory
• Helps skin from sagging
• Increases libido
• Helps treat Erectile Dysfunction
• Improves firmness of erections
• Increases energy/vitality
• Increases endurance
• Helps with low self-esteem
•  Increases HDL, lowers LDL
• Improves anxiety
• Improves irritability
• Improves depression
• Improves competitive drive
• Improves motivation
• Supports the immune system
• Improves joint pain
• Helps urinary incontinence
• Helps with weepiness
• Helps in tissue repair
• Improves sleep
• Improves headaches
• Improves longevity
• Helps to regulate blood sugar
• Enhances oxygen uptake
• Helps protect against Alzheimer’s
• Helps to maintain cardiovascular health
• Improvements in Mood
• Improvements in Bone Density and strength
• Increases in Muscle Mass and strength
• Decreases in Abdominal Belly Fat 

Possible side effects for men on TRT are acne, oily skin, prolonged erections, unwanted hair growth/loss, enlargement of breast tissue (though, your Broad Health physician will monitor and treat estrogen levels appropriately), minor testicular atrophy, fluid retention, increase in blood pressure, decreased sperm count with possible infertility, an increase in the number of red blood cells (erythrocytosis) with corresponding increase in hematocrit and/or hemoglobin (your blood will be monitored for this and appropriate treatment initiated if needed). Many of these side effects can be temporary as your body adjusts to restoration. Some of these potential side effects can often be addressed by adjusting hormone levels or prescribing simple remedies. 

There remains controversy regarding the correlation between the use of bioidentical hormone therapy and the potential risk of cancer in those patients who have a strong family history of prostate, testicular, breast or ovarian cancer. TRT may be considered experimental because of the lack of adequate scientific evidence or peer-reviewed publications supporting the underlying premise of TRT and such therapy might even be considered by some medical professionals to be medically unnecessary because it is not aimed at treating a particular disease. 

Careful surveillance and close monitoring are requirements of all patients to minimize any possible risk. Your Broad Health physician will monitor your hormone levels and various other laboratory values as they pertain to your treatment goals. 

If topical hormone replacement treatment (cream, gel, etc) is prescribed, you must take extreme care to avoid any collateral exposure via direct skin-to-skin contact with the application site or exposure to contaminated bed linens, clothes, etc. for any children, pets, co -habitants of the home, or anyone else whom may come into contact with the hormonal treatment cream/gel. Accidental collateral exposure may significantly impact the hormone levels of those affected.  

For a disclosure of indications and usage, limitations of usage, contraindications, warnings and precautions, adverse reactions, risk of drug abuse and dependence, overdosage and other related patient counseling information, please carefully review the U.S. Food and Drug Administration’s (FDA) warning label found here.

2.      Other Screenings and Limitations.

TRT treatments rendered through Broad Health are solely for the purpose of hormone optimization. Broad Health does not offer primary care and cannot take the place of a Primary Care Provider (PCP).  If you do not have a PCP you are encouraged to establish a relationship with a PCP and communicate your TRT treatment received at Broad Health to your PCP, endocrinologist, and/or urologist to encourage and facilitate physician communication regarding your TRT treatments.  

Broad Health's engaged physicians do not perform in-person physical examinations since their interaction with you will be via telemedicine. A physical examination includes a  digital rectal exam (DRE), which is a test that examines a person's lower rectum, pelvis, and lower belly. This test can help your doctor check for cancer and other health problems including prostate cancer and an abnormal mass in the anus or rectum. An integral part of overall health maintenance is obtaining and remaining up to date with age and sex appropriate screening tests and physical examinations aimed at early detection of disease. You should consult with your primary health care practitioner or urologist about these examinations. You will be responsible to provide your Broad Health physician with all appropriate medical records and/or facilitate inter-health care practitioner communication regarding such evaluations.

3.      Alternative Treatment Methods and Their General Nature. 

Reasonable alternatives to TRT include:

1. Leaving hormone levels as they are.
2. Treating age related diseases as they appear.
3. Using pharmaceutical agents that are not bioidentical in nature (synthetics).

Before you take any medication, there are a number of important lifestyle changes you should consider, since they could improve your hormone imbalance or low testosterone levels:

• Get regular quality sleep - 7-9 hours of uninterrupted sleep nightly
• Quality exercise, which should include: aerobic exercise, high intensity interval training, stretching (yoga), and resistance exercise.
• Reduce or stop alcohol consumption (no more than one drink daily).
• Eat a balanced diet of quality food
• Reach and maintain optimal body weight
• Take selected supplements to support your diet
• Practice stress reduction techniques
• Do not consume tobacco products
• Stay well hydrated
• Maintain optimal dental hygiene.
• Maintain quality connections with family and friends. 

Each patients’ situation is unique (biology, environment, psychology) and it is up to the Broad Health physician to determine if and when a patient should try medication in addition to lifestyle modifications. 

4.      Patient’s Obligations and Representations.

If prescribed TRT, you will be responsible for self-administering the hormones prescribed.  To ensure your safety and stay in compliance with the treatment plan, you acknowledge and represent the following:

1. I will carefully follow instructions, recommended dosage, and methods of administration.
2.  I will participate in the initial and subsequent hormone testing, as required to safely monitor and treat my hormone levels.
3.  I will be under the regular care of another physician (Primary Care Physician Urologist, Endocrinologist, etc.) for all other medical conditions. I will consult my physician(s) for any other medical services I may require. I understand Broad Health is a specialized practice focused solely on hormone optimization.
4.  I understand that I may suspend or terminate TRT at any time and hereby agree to immediately notify my Broad Health physician of any desire to suspend or terminate this treatment so that such suspension or termination may be done safely.
5.  I understand my Broad Health physician may be assisted by other health professionals, as necessary, and agree to their participation in my care as it relates to the evaluation and treatment of the conditions this TRT Consent covers.
6.  I certify that I am 18 years of age or older, am competent to sign this TRT Consent, and have done so of my own free will.
7.  I will immediately report any adverse side effects related to the use of my medication to my Broad Health physician.
8.  I will not share, sell or trade my medication for money, goods or services.
9.  I will use my medication at the prescribed rate and dosage and will keep the medications in its respected labeled container and will safeguard my medications from loss or theft.
10.  I will not attempt to obtain scheduled TRT medications illegally or from any other health care practitioner without disclosing my current medication usage. I understand that it is against the law to do so.
11.  I am responsible for remaining up to date on all age-appropriate screenings including, but not limited to, colonoscopy, PSA and DRE (digital rectal exam), cardiac screenings as necessary (stress test, etc.) through the appropriate health care provider(s) (PCP, cardiologist, urologist, etc.). 
12.  I will notify my Broad Health physician of any change in my medical history.