Informed Consent for Treatment

 Informed Consent to Treat

This form is called an “Informed Consent Form.” Its purpose is to inform you about Bio-identical Hormone Replacement
Therapy (BHRT) that your provider (physician, nurse practitioner, physician’s assistant) has discussed with you. You should
read this form carefully and ask any questions before you decide whether to give your consent for this therapy.
As with all treatments, there are potential risks and benefits of both treatment and forgoing treatment. Treatment carries the
potential risk of unsuccessful results, complications, and injury from both known and unforeseen causes. There is no warranty or
guarantee made as to a result or cure. You have the right to be informed of such risks as well as the nature of the treatment, the
expected effects of therapy, the available alternative methods of treatment and their risks and benefits, and the controversies
regarding the most appropriate diagnosis and treatment.

The Principals of Medical Ethics adopted by the American Medical Association in 1980 states that a physician shall continue to
study, apply, and advance scientific knowledge, make relevant information available to patients, colleagues, and the public. An
essential component of informed consent requires that in the absence of medical certainty, patients have the opportunity to
choose among medically indicated treatments. The American Medical Association’s code of ethics states, “The principle of
patient autonomy requires that competent patients have the opportunity to choose among medically indicated treatments and to
refuse any unwanted treatments.” Because choice can only be preserved by understanding and acknowledging divergent
viewpoints on treatment options and providing those treatment options, this document, along with the discussion with your
physician or provider, is designed to provide you with such information.

 

Background: You have been diagnosed with a relative or absolute deficiency of estrogen, testosterone, or progesterone, thyroid, DHEA, pregnenolone, cortisol, vitamin D and/or other hormones or a
combination thereof. You may potentially benefit from hormonal supplementation. Your provider has recommended treatment
with BHRT which consists of either progesterone and /or testosterone and/or estradiol and/or thyroid hormone. The goal is to provide you with the most up-to-date therapy options. You need to be sure you understand the reason that this therapy is being prescribed, the potential
risks of therapy and the potential risk of declining treatment.

We also feel it is important that you know there are significant controversies regarding the best method to diagnosis and treat symptoms related to perimenopause and menopause, thyroid deficiency and hormonal imbalances, the best methods of treatment, and the most appropriate way to monitor therapy. This is especially true when “standard” blood tests look “normal”. Thus, you may consult another doctor who does not agree with the therapy. This document provides extensive information so that you understand the basis for the diagnosis, the treatment method, and the potential risks and benefits of treatment and declining
treatment.

Do not undergo therapy until you have reviewed this document, thoroughly understand the potential risks and benefits of treatment, and have all your questions answered. It is assumed that before your initial telemedicine visit during the sign up process that you have read and understand this document and will present additional questions directly to Brandy Chappell, ARNP during your initial telemedicine visit. This document is presented to you first, several days ahead of your initial visit so that you may prepare.

The diagnosis and treatment used may be considered non conventional, complementary or alternative. Other physicians may disagree with the need for treatment, the method of treatment and dosing, and/or the methods of monitoring. You agree to undergo testing as recommended by your provider and report any potential side effects immediately.

Therapeutic Basis: Many individuals have inadequate hormone levels despite technically “normal “blood tests. There are limitations to “measuring” hormone levels as it reflects what is in the serum or saliva only rather than inside the cell. Some individuals suffering symptoms related to peri-menopause, thyroid, menopause and hormone deficiency may benefit from these therapies. Bio-identical hormone
replacement therapy and can be used to augment hormone levels in a number of conditions where diminished hormone “levels”
are evident or clinically suggestive based on symptoms. The providers at Bloom Health Care may prescribe these hormones at dosages designed to achieve a pharmacologic effect to reduce the symptoms of hormonal decline.

The diagnosis and treatment will involve many components including your symptoms, confounding medical issues or
medications, blood levels, response to therapy, possible side effects, individual reaction/response to therapy, and other information. Your blood levels may fall into “normal” lab reference ranges, which may not in our opinion, reflect your deficiency.

We also feel it is important that you know there are significant medical differences of opinion/controversies regarding the best
method to diagnosis and treat low hormone levels, whether or not blood tests are needed at all, the best methods of treatment, and the most appropriate way to monitor dosage and therapy. This is especially true when “standard” blood tests are “normal”, meaning that the result is within the normal laboratory reference range for the test. The diagnosis and treatment used may be
considered non-conventional, complementary or alternative. Other physicians may disagree with the need for treatment at all, the method of treatment, dosing and/or the methods of monitoring. Thus, you may consult another doctor who does not agree with our diagnosis or therapy.

Informed Consent for Hormone Therapy Exceeding Standard Guidelines

Purpose of Treatment

You are considering hormone therapy (HT) to manage symptoms related to hormonal imbalance, menopause, testosterone deficiency, thyroid dysfunction, or other medical conditions. Standard medical guidelines recommend maintaining hormone levels within physiologic ranges. However, some clinical approaches suggest potential benefits from higher-than-recommended hormone levels.  This means your lab tests will show elevated out of range levels.  At Bloom we treat based on symptom improvement and use labs as a guide only. 

This document explains the risks, benefits, and alternatives so you can make an informed decision before proceeding with treatment.

  1. Hormones Considered in Treatment

Your treatment may involve one or more of the following hormones:

  • Estrogen Therapy (for menopause symptoms, osteoporosis, cardiovascular health)
  • Testosterone Therapy (for energy, libido, muscle mass, cognitive function)
  • Progesterone Therapy (for hormone balance, sleep support, endometrial protection)
  • Thyroid Hormones (for metabolism, energy, weight management)
  • Other Hormone Therapies (as determined by your healthcare provider)
  1. Potential Benefits & Risks

Hormone

Potential Benefits

Potential Risks of Higher-Than-Recommended Levels

Estrogen

Menopause symptom relief, bone health, cardiovascular benefits

Increased risk of blood clots, stroke, breast/endometrial cancer, abnormal bleeding

Testosterone

Improved libido, energy, muscle mass, cognitive function

Acne, hair loss, mood changes, cardiovascular risks, liver strain

Progesterone

Mood stabilization, sleep support, endometrial protection

Drowsiness, dizziness, possible increased risk of breast cancer in some cases

Thyroid Hormones

Increased energy, weight loss, improved metabolism

Heart palpitations, bone loss, anxiety, arrhythmias, osteoporosis risk

  1. Standard Guidelines vs. Individualized Treatment
  • Standard medical guidelines recommend staying within physiologic ranges for safety.
  • Some research and clinical practice suggest that higher hormone levels may offer benefits, but long-term risks are not fully known.
  • There may be a lack of large-scale, long-term studies proving the safety of hormone therapy at elevated levels.
 
  1. Alternative Treatment Options

You may choose:
☑ Standard-dose hormone therapy within recommended guidelines. Tell your provider so we can keep your levels in range.
☑ Non-hormonal treatments (lifestyle changes, supplements, medications)
☑ No treatment

  1. Acknowledgment of Risks

By proceeding with this treatment, you confirm that you:
Understand that your hormone levels may exceed traditional guidelines.
Acknowledge that this treatment may carry increased health risks.
Recognize that long-term effects are not fully understood.
Agree to report any concerning symptoms to your provider.
Have had the opportunity to ask questions and receive answers from your provider

Expected Benefits of Hormone Replacement Therapy may include:


♦ Control of symptoms associated with declining hormone levels.
♦ May help prevent, reduce or control physical diseases and dysfunction associated with declining hormone levels.

 I agree that: I have been fully informed, and I am satisfied with my understanding, that this treatment may be viewed by the medical community as new, controversial and unnecessary.
The long-term effects of these hormones have not been established, particularly as it relates to breast cancer, and
cardiovascular disease and thrombosis
I understand that my healthcare provider cannot guarantee any health benefits or that there will be no harm from the
use of hormone replacement therapy.

Risks and Side Effects of Hormone Replacement Therapy may include:


❖ Route of Administration
♦ Topical creams can be transferred to other family members and pets result in a local skin reaction or other issue.

Benefits and Potential Risks/ Side Effects of Individual Hormones
Testosterone:
♦ A prescription hormone given by injection, troche, or transdermal cream.
♦ It is not FDA approved for women and is considered “off-label” use for symptomatic improvement in women
♦ Potential benefits: increased libido, energy and sense of well- being, decreased frequency/severity of headaches,
increased energy, decreased hot flashes, increase in muscle mass and decrease in visceral fat, improved insulin
sensitivity, improved lipid panel, decreased risk of dementia, decreased bone loss, improved cognition and memory
and help with sleep issues, reduced risk of reproductive cancers, reduced risk of cardiovascular disease.
♦ Risks of testosterone replacement may include, but are not limited to: an increase in red blood cells
(erythrocytosis) reduced insulin requirements in insulin-dependent diabetics, increased estradiol levels, edema (fluid
retention), reproductive cancers, and cardiovascular disease.
♦ Side effects may include, but are not limited to: enlarged clitoris, hair loss, temporary water retention, acne,
irritability, and voice changes. These are mostly dose related and usually resolve with reduction in dose.

Testosterone is not prescribed as a monotherapy in the majority of cases for menopausal women.  It may be considered for those with a history of estrogen receptor positive breast/uterine cancers. 

Premenopausal females should use birth control or other means of contraception. Theoretically, testosterone can masculinize a female fetus.

Estrogen (estradiol and/or estriol):
♦ A prescription hormone, given by oral tablet, cream, vaginal cream, patch, or troche.
♦ Potential benefits: increased libido, sense of well-being, increased energy, decreased hot flashes/night sweats,
decreased vaginal dryness, decreased risk of heart disease and cardiovascular disease when started in the first 10
years of menopause, decreased risk of dementia, decreased bone loss, improved cognition and memory, help with
sleep issues, helps with urinary incontinence.
♦ Risks of estrogen replacement include, but are not limited to: heart attacks, blood clot formation, stroke, breast
cancer, liver disease, gallstones, increased risk of uterine cancer, and fibroid tumors.
♦ Side effects may include, but are not limited to: increased body fat, bloating, breast swelling/tenderness, fluid
retention, uterine bleeding, depression, headaches, impaired glucose tolerance and aggravation of migraines.

Progesterone:
♦ A prescription hormone, given orally, rectally, topically, or vaginally or a combination of these delivery methods.
♦ Potential benefits: protection from estrogens effect on the uterus and breast thereby reducing risk of endometrial
(uterine) and breast cancer, treatment of irregular menstruation, improved sleep quality, improved anxiety.
♦ Side effects can include, but are not limited to: acne, drowsiness or dizziness.
♦ Progesterone has not been shown to cause any risks or increase the risk of thrombosis or breast cancer in the
medical literature. However, long term risks of breast cancer or other medical problems have not been definitively
proven

Dehydroepiandrosterone- DHEA:
♦ DHEA is classified as a dietary supplement given orally or by transdermal cream or vaginal suppository.
♦ Risks of DHEA replacement include but are not limited to: worsening of certain cancers and should be avoided
in women with breast cancer.
♦ Side effects of DHEA replacement are generally dose related and may include but are not limited to: acne or
oily skin, hair growth on the face, arms or legs, acne in women, prostate enlargement in men, male pattern baldness,
decreased HDL cholesterol, fatigue, mood changes, weight gain and insomnia.

Alternatives to Hormone Replacement Therapy
I understand the alternatives to bio-identical hormone replacement therapy include, but are not limited to:
♦ Leaving the hormone levels as they are and doing nothing. Risks may include, but are not limited to: experiencing
symptoms of hormone deficiency, and increased risk for aging-related diseases or dysfunction resulting from
declining hormone levels. This alternative may result in the need to treat diseases or dysfunctions associated with
declining hormone levels.
♦ Treating the symptoms of declining hormone levels as they develop with non-hormonal therapies such as SSRI’s
(antidepressants), sleeping pills, and herbal therapies, essential oils, lifestyle modifications such as weight loss,
stress reduction, yoga, etc.
♦ Seeing another provider who believes in using non-bioidentical synthetic hormones such as Premarin and Prempro

Using non pharmaceutical agents such as soy/diet/exercise/sleep hygiene.

Using synthetic FDA approved medications for my particular symptom.  

The Nature of the Treatment
I hereby give my consent to evaluation and treatment by Bloom Health Care, LLC AND Brandy Chappell, ARNP and other healthcare practitioners of the following specified condition(s):

Women: pre-menopause or menopausal symptoms (including potential repletion of estrogen/estradiol, progesterone, DHEA, testosterone, and weight loss medications), sexual disfunction, libido decrease, mood changes, hot flashes, insomnia, head aches, night sweats, urinary and bladder issues all which encompass menopausal and premenopausal symptoms but are not limited to just these symptoms.

In addition:

I acknowledge that treatment with compounded and non compounded medications such as testosterone, estradiol, progesterone, estriol, estrogens, for the purpose of bioidentical hormone replacement therapy, hormone optimization are considered off label use. These medications may  not be FDA approved for the use of health optimization, wellness, hormone replacement, weight loss and/or for anti-aging purposes, or my symptoms.  Off label use means the drug is being used for a condition which it has not been specifically approved.  For example Botox is approved for excessive sweating but it’s used off label for wrinkles which it is not approved.

I elect to voluntarily undergo treatment and agree to the administration of hormone replacement therapy and drugs designed to alter hormone levels, all as appropriate to my specific diagnosis, particular condition and treatment objectives.

I understand the alternative treatments and am choosing to consent to the treatment plan prepared for me by Bloom Health Care LLC to address the condition/conditions listed above.

Safety of Hormone Replacement

Although, in my medical providers opinion, the majority of data points toward safety, there remains controversy regarding the correlation between the use of bioidentical hormone therapy and cancer. Recent data demonstrates that natural progesterone and estriol/estradiol may be protective against breast cancer.

Available data supports the safety of hormone replacement therapy in women, and it is of the opinion of Bloom Health Care, LLC and/or Brandy Chappell, ARNP that treatment is safe, but there still remains controversy regarding the correlation between the use of bioidentical hormone replacement and cardiovascular events such as but not limited to: strokes, heart attacks, and blood clots. Some studies have shown correlations between hormone replacement therapy and cardiovascular disease while others show no correlation or even a benefit in preventing cardiovascular disease.

I understand that careful surveillance and close monitoring are requirements of all patients to minimize any possible risk. I understand that Brandy Chappell, ARNP will monitor my hormone levels and various other laboratory values as they pertain to my treatment goals. However, I also understand that an integral part of health maintenance is obtaining and remaining up to date with age appropriate screening tests aimed at early detection of life-threatening diseases. I will obtain these tests such as mammogram and pap smears with my primary care provider and report results to Brandy Chappell, ARNP.

I understand that close monitoring is required by all patients to minimize and prevent any possible risks. I understand that Brandy Chappell, ARNP will monitor my testosterone levels should I elect to undergo treatment with testosterone. I also understand that it is important to stay up to date with routine screening and health maintenance by my primary care provider to prevent and detect any possible life-threatening diseases or conditions.

 I agree to obtain and remain up to date on all age-appropriate screenings including, but not limited to, DEXA scans, mammograms (you should have these , PAP smears, pelvic exams, colonoscopies, cardiac screenings, and any other type of recommended health screenings. I agree to obtain these screenings through the direction of my primary care provider and/or OB/GYN and/or cardiologist and will not hold Bloom Health Care LLC, Brandy Chappell NP, or any staff responsible or liable for performing these health maintenance screenings or the treatment of any other conditions not relevant to my treatment goals with Bloom Health Care LLC.

 BLOOM HEALTH CARE, LLC, BRANDY CHAPPELL, ARNP strongly recommend obtaining yearly mammograms. I understand that certain types of breast cancer, once present, can be stimulated to grow faster by estrogen that is prescribed or even the estrogen within your body. Taking estrogen therapy with an active breast cancer could potentially decrease your chances of survival. Therefore, it is imperative to obtain appropriate yearly screenings.

 I agree to notify BLOOM HEALTH CARE, LLC AND Brandy Chappell, ARNP immediately if I am to become pregnant while on hormone replacement therapy and to stop it immediately. I understand that being on hormone therapy and becoming pregnant could present a risk to an unborn child. I understand that taking testosterone during pre menopause while I am still having periods requires me to use contraception as testosterone could potentially masculinize a female fetus. It is my responsibility to comply with this requirement and I will hold harmless Brandy Chappell, ARNP and Bloom Health Care, LLC for any adverse event.

I want to initiate treatment at BLOOM HEALTH CARE, LLC and I give permission to BLOOM HEALTH CARE, LLC and BRANDY CHAPPELL, ARNP and additional staff of BLOOM HEALTH CARE, LLC to begin treatment without knowing results of age-appropriate and health maintenance screenings. In doing so, I release BLOOM HEALTH CARE, LLC, BRANDY CHAPPELL, ARNP and other healthcare practitioners of any claims of liability for cardiovascular events, ovarian cancer, breast cancer, uterine cancer, cervical cancer and/or colon cancer. Further, I agree to immediately notify BLOOM HEALTH CARE LLC, BRANDY CHAPPELL, ARNP  of any abnormal findings on any health screenings done by my primary care provider.

I attest that I do not have any of the following conditions that would prevent me from obtaining care with Bloom Health Care, LLC or Brandy Chappell, ARNP;

  • History of breast, endometrial, cervical or estrogen based cancer.
  • Current cancer diagnosis/treatment.
  • Pregnant or breast feeding.
  • Unexplained vaginal bleeding
  • Uncontrolled high blood pressure.
  • Blood clotting disorders
 
 

My Obligations and Representations

Any questions I have regarding this treatment have been answered to my satisfaction. I understand that I will be responsible for administering the hormones and/or medications prescribed to me. I also promise to comply with the dosages and frequency of medications prescribed to me.

I certify that I am under the regular care of a primary care  provider or an OB/GYN or a Women’s Health Specialist for any other conditions I might have or am found to have. I will consult with my primary care provider or specialist regarding any other condition I might have. I understand that if I do not have a primary care provider, that I will be encouraged to seek one out. I acknowledge that I am seeking care at BLOOM HEALTH CARE, LLC for the specific services BLOOM HEALTH CARE, LLC offers. I acknowledge I am not wanting to establish primary care with BLOOM HEALTH CARE, LLC and I am here for specialized care including hormone restoration, hair loss, skin conditions such as acne, wrinkles, redness/rosacea, sexual issues, menopausal and perimenopausal symptoms, vaginal and bladder health, weight loss.

I have reviewed the mentioned risks and have determined the benefits outweigh the possible risks associated with hormone restoration and treatment with BLOOM HEALTH CARE, LLC.  I release any claim in court or any type of complaint that could result from treatment with BLOOM HEALTH CARE, LLC, BRANDY CHAPPELL, ARNP and any other staff associated with BLOOM HEALTH CARE, LLC and will not hold liable any Brandy Chappell, ARNP or staff of BLOOM HEALTH CARE, LLC.

I understand that treatment modalities utilized by BLOOM HEALTH CARE, LLC might not be supported by scientific/medical literature and could be seen as experimental or based off anecdotal claims. Many medical providers, including endocrinologists and OB/GYNs, might see these types of treatments as not medically necessary.

Medication Adjustment Policy & Legal Liability

I understand that self titration or adjusting, increasing, decreasing, or discontinuing any prescribed hormone therapy — including estrogen, testosterone, thyroid medication, progesterone, DHEA, pregnenolone, or cortisol — without the prior knowledge and written approval of Brandy Chappell, ARNP or her designated provider is strictly prohibited.

I agree not to self-titrate or interpret my own lab results for the purpose of modifying my dosage. I understand that all changes must be discussed and approved through a scheduled visit or secure message, allowing a minimum 48-hour response window for safe medical review.

Emergency Exception:
In the event of a medical emergency, or if I am under the active care of another licensed medical provider who recommends modifying or discontinuing hormone therapy, I may temporarily stop or adjust treatment. In such cases, I agree to notify Bloom Health Care, LLC within 72 hours, and provide documentation from the treating provider, if applicable. I understand that failure to communicate these changes in a timely manner may interfere with continuity of care and does not waive liability for any adverse outcome.

I acknowledge that self-directed changes may result in significant risks, including hormonal imbalance, cardiovascular events, metabolic disruption, or worsening of symptoms. I accept full responsibility for any negative outcomes that result from unauthorized medication adjustments and hereby release Bloom Health Care, LLC, Brandy Chappell, ARNP, and her team from liability in such instances.

Consent

I hereby authorize (BLOOM HEALTH CARE, LLC), (BRANDY CHAPPELL, ARNP)  and additional staff of (BLOOM HEALTH CARE, LLC) to evaluate and treat conditions that I have consented for. I consent to obtaining blood work before treatment with testosterone and during so hormone levels can be monitored and appropriate treatment can be prescribed. I certify that I am signing this under my free will and am competent to make my own medical decisions. 

Indemnification Clause

I, agree to indemnify, defend, protect, and hold harmless BRANDY CHAPPELL, ARNP, medical providers employed by BLOOM HEALTH CARE, LLC and BLOOM HEALTH CARE, LLC; and their respective officers, directors, employees, stockholders, assigns, successors and affiliates (Indemnified Parties) from, against and in respect of all liabilities, losses, claims, damages, judgements, settlement payments, deficiencies, penalties, fines, interest and costs, expenses suffered, sustained, incurred or paid by the indemnified parties, in connection with, results from or arising out of, directly or indirectly, BRANDY CHAPPELL, ARNP, medical providers employed by BLOOM HEALTH CARE, LLC and BLOOM HEALTH CARE, LLC; rendering medical care, services, advice, and/or treatment, my failure to disclose all relevant information regarding my medical and physical condition, acts or omissions, of BRANDY CHAPPELL, ARNP, (BLOOM HEALTH CARE, LLC), LLC; harm or injury resulting from medical care or pharmaceuticals provided directly or indirectly by (BRANDY CHAPPELL, ARNP), NP or (BLOOM HEALTH CARE, LLC) LLC. I am aware of the potential side effects associated with the above treatments, accept all the risks involved in taking the medication and will not seek indemnification or damages from the indemnified parties.

Thyroid Treatment Disclosure & Consent (Addendum) 6/24/2025

As part of my individualized hormone and wellness care, I may be offered thyroid-focused treatment, including options that may fall outside of conventional treatment guidelines used in standard endocrinology or primary care.

1. Treatment Overview

Thyroid treatment may include, but is not limited to:

  • T3-only therapy or combination T4/T3 therapy

  • Use of desiccated thyroid hormone (e.g., NP Thyroid, Armour)

  • Lab interpretation outside conventional TSH-only models

  • Treatment based on symptoms, basal body temperature, and other clinical indicators

  • Nutritional or supplement-based thyroid support

2. Medical Position Statement

These treatment options may be considered “off-label,” non-standard, or alternative by mainstream medical organizations. While commonly used in functional and integrative medicine, some treatments may lack large-scale randomized controlled trials or FDA-specific labeling for thyroid use.

I understand that:

  • These approaches are based on clinical judgment, evolving research, and functional medicine principles.

  • This form of care is not universally accepted by the medical community.

  • My treatment will be monitored for safety and effectiveness with labs and follow-up.

3. Risks and Side Effects

Potential risks may include:

  • Symptoms of over- or under-active thyroid (e.g., palpitations, anxiety, fatigue, weight change)

  • Cardiovascular effects such as rapid heart rate or arrhythmia

  • Bone density concerns with prolonged over-treatment

  • Medication interactions or allergic reactions

I understand that I must report new or concerning symptoms and attend all recommended follow-up appointments.

4. Voluntary Participation & Alternatives

I confirm that:

  • I have been informed of alternative conventional treatment options (e.g., Synthroid/Levothyroxine only, referral to endocrinology).

  • I understand the benefits and risks of the treatment plan recommended by BloomHRT.

  • I may seek a second opinion at any time and may discontinue treatment after notifying my provider.

5. Acknowledgment and Consent

By signing below or clicking “I Agree,” I confirm that I:

  • Have read and understood this Thyroid Treatment Consent section.

  • Have had the opportunity to ask questions and receive answers.

  • Give my informed, voluntary consent to receive thyroid-related care under this model.