Frequently Asked Questions

Volunteering to participate in clinical research is an important and unique way to make a lasting difference in the lives of others. The lives of millions of people are positively impacted due to advances in science and technology. The willingness of hundreds of thousands of individuals to participate as clinical trial volunteers has allowed these advances to happen. Without the help of trial participants, there would be no advancements in medical care or knowledge that could improve the health of future generations.

If compensation is available for a specific trial, the Research Staff will review that with you at your initial review/screening.

A placebo is a harmless, inactive substance made to look like the actual medicine used in the clinical trial. The purpose of a placebo is to reduce bias and ensure trial results are more reliable. Placebos are often used in trials when current medical guidelines recommend no treatment. The consent form will outline whether or not a placebo is part of a particular trial. Trial applicants should ensure they understand what research approach is being used in the study as it may affect their decision whether or not to participate.

Randomization in clinical trials is when two or more alternative treatments are available for patients. Randomization is essential to ensure that any differences between the treatments being tested do not result from bias. In randomized controlled trials (RCTs), patients are assigned randomly to one of several treatment groups; patients are assigned by chance rather than choice. Researchers perform analysis at intervals during a trial, which may last years. If one treatment generates significantly better results than another, the trial closes.

Subjects who agree to participate in clinical research can expect that the activity will entail risks. These risks are not different from those experienced in activities of daily living, such as driving a car and should not deter you from considering participation. However, participants should be aware of the risks before enrolling in a clinical trial. The clinical trial risks are outlined in the consent document, which volunteers must sign before participating. The Research Team will also explain the risks to participants and answer any questions. If a participant chooses to volunteer for a study, they should carefully consider the risks. The knowledge gained from a clinical study will help others, even though there may be no direct benefits to a participant.

Colorectal cancer typically arises from irregular growths in the colon or rectum known as polyps. During a colonoscopy exam, these premalignant polyps can be removed to help minimize the risk and possibly prevent the development of colorectal cancer. Regular colon cancer screenings may also allow doctors to identify cancer already present. It may be easier to treat colon or rectal cancer when it is detected early on.

Adults with an average risk are advised to begin regular colorectal cancer screenings upon turning 45. Those who carry a higher risk might need to screen even earlier. Your gastroenterologist can help you determine when you should start screening for colorectal cancer.

The intervals at which adults should have colorectal cancer exams can depend on the type of evaluation being performed. Generally, those aged 45 and older should undergo a colonoscopy once every decade when they are at average risk of developing colorectal cancer and have normal colonoscopy results. Patients with a significantly high risk should have colonoscopy exams at least once every five years. For details on how frequently you should have screening exams for colorectal cancer, please consult your gastrointestinal specialist.

The preparation process for a colon cancer screening will be based on the form of screening scheduled. When undergoing a colonoscopy, detailed prep instructions will be provided by your GI team ahead of the procedure to clear out your large intestine (colon). There may also be specific directions to follow in the days leading up to your exam. It is essential to comply with your physician’s directions to help ensure they can identify any concerns when performing your colorectal cancer screening.

Chronic care management is a specific care management service that provides coverage for patients with two or more chronic conditions for a continuous relationship with their care team. This includes formulating a comprehensive care plan, interactive remote communication and management (usually over the phone), medication management, and coordination of care between providers.

Chronic care management is beneficial for patients in terms of ongoing health and wellness support, increased access to appropriate medical resources, enhanced communication with members of their care team, reduction in emergency room visits and hospitalization or readmissions, and increased engagement in their own healthcare.

Any patient having two or more qualifying chronic health conditions that are expected to last at least 12 months or until their death, or if the patient’s chronic health conditions put them at significant risk of death, acute exacerbation, or functional decline are eligible for Chronic Care Management services.

CCM for patients with chronic GI Disease such as: IBD, IBS, PEI and esophageal disorders. ADHs focus currently is on IBD, with other diagnosis being a supportive diagnosis. CCM for chronic Liver Disease such as: NAFLD, obesity, metabolic syndrome and related conditions.

Anyone on the Patient’s medical team (MDs, RNs, MAs, etc) can administer CCM services. GIA Providers who offer CCM services have met CCM requirements as outlined by Medicare and are qualified to provide CCM services.

No

There is normally a 20% copay for Medicare patients. Commercial insurance rates vary and may be subject to deductible, flat rate for service or a % of billed amount. GIA recommends patients to check with their insurance providers prior to enrolling in CCM services to verify eligibility and associated costs.

The minimum chronic care management service period is one calendar month and is available for as long as the patient meets the requirements of: having two or more qualifying chronic health conditions that are expected to last at least 12 months or until their death, or if the patient’s chronic health conditions put them at significant risk of death, acute exacerbation, or functional decline.

Explicit written consent must be received from patients and documented in the patient chart to be enrolled in the GIA CCM program. Eligible patients must have: two or more chronic conditions that are expected to last at least 12 months or until death; the chronic condition must place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline.

What happens if I don’t experience any improvement with CCM services?

Patients cannot switch providers within the organization, however they can unenroll from services entirely and can choose a different provider from a different organization. However, they will not be eligible to receive services until the following calendar month, as only one provider can provide and bill for services within a calendar month.

No. Insurance/Medicare will only allow one Provider to provide CCM services and bill for said services in the calendar month.

No. A GIA provider can recommend and encourage patients to follow-up with your PCP or other specialists as appropriate, but cannot treat conditions outside of the gastroenterology scope of practice

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