Informed Consent Prompt Templates

Consent Conversation: Epidural Steroid Injection

Setting: Private room, patient seated comfortably, enough time for questions.

OPENING:
"Before we do the injection, I want to make sure you understand what we're doing, what the risks are, and that you have a chance to ask questions. This isn't a test. I just want you to feel comfortable with your decision."

WHAT WE'RE DOING:
"We're going to inject a steroid medication into the epidural space in your lower back. That's the area around your spinal nerves. The steroid reduces inflammation, which should help with the leg pain you've been having."

[Check understanding]: "Does that make sense so far?"

WHY WE'RE RECOMMENDING THIS:
"You've tried physical therapy and medications, and you're still having significant pain that's affecting your daily life. This injection is the next step before considering surgery. For many people, it provides enough relief to avoid an operation."

WHAT TO EXPECT DURING:
"You'll lie face down on a table. We'll clean your back and numb the skin with a small needle. That's the only part that should hurt, and it's like a pinch. Then I'll use X-ray guidance to place the needle in the right spot and inject the medication. The whole thing takes about 15-20 minutes."

RISKS:
"Let me tell you about the risks. I'll start with the common ones, then the rare but serious ones."

Common (happen to some patients):
• "Temporary increase in pain for a day or two after. This happens in about 10% of people and goes away."
• "Headache if we accidentally puncture the covering of the spinal cord. This is uncommon, maybe 1%. If it happens, it's treatable."
• "The steroid can temporarily raise your blood sugar if you have diabetes. We'll monitor that."

Rare but serious:
• "Infection. Very rare, less than 1 in 1,000, but it's why we use sterile technique."
• "Bleeding, especially if you're on blood thinners. That's why we had you stop them."
• "Nerve damage. Extremely rare. I've done hundreds of these and haven't seen permanent nerve injury."
• "Allergic reaction to the medication. Also very rare."

[Pause]: "I know that's a lot. Any questions about the risks?"

ALTERNATIVES:
"You don't have to do this. Your options are:"
• "Continue with medications and PT. You might improve more slowly, or you might not improve without intervention."
• "Move directly to surgery. Given your imaging, you'd be a candidate, but surgery has its own risks and recovery."
• "Do nothing and live with the symptoms. That's your choice, and I'll support it if that's what you decide."

WHAT TO EXPECT AFTER:
"You'll rest for about 30 minutes after the injection. Some people feel relief right away. For others, it takes a few days for the steroid to work. The full effect is usually within 1-2 weeks."

"The injection doesn't fix the underlying problem. It reduces inflammation and pain so you can do PT and hopefully heal. Some people need one injection, some need a series, and some eventually need surgery anyway."

QUESTIONS:
"What questions do you have for me?"
[Pause and wait. Don't rush this.]

"Is there anything I explained that you'd like me to go over again?"

CLOSING:
"Do you feel like you understand what we're doing, the risks, and your options?"

[If yes]: "Okay, I'll have you sign the consent form, which just documents that we had this conversation. Then we'll get you ready."

[If uncertain]: "Let's slow down. What part would you like to discuss more?"

INFORMED CONSENT DOCUMENTATION

Date: [Today]
Patient: [Name], DOB: [Date]
Procedure: Colonoscopy with possible polypectomy
Indication: Colorectal cancer screening, age-appropriate

Consent Discussion:

I met with the patient to discuss the planned colonoscopy. The following was explained in language the patient could understand:

Procedure:
The patient was informed that a colonoscopy involves passing a flexible camera through the colon to look for polyps, cancers, or other abnormalities. If polyps are found, they will typically be removed during the same procedure (polypectomy) and sent for analysis.

Benefits:
Colonoscopies can detect and remove precancerous polyps, preventing colorectal cancer. Early detection of cancer improves outcomes.

Risks Discussed:
• Bleeding, especially if polyps are removed (approximately 1 in 100-200 polypectomies; usually minor and self-limited; rarely requires intervention)
• Perforation (tear in the colon wall): rare (approximately 1 in 1,000), but serious if it occurs; may require surgery
• Adverse reaction to sedation: rare; anesthesia team monitors throughout
• Incomplete procedure due to poor preparation or anatomical factors
• Missed lesions: colonoscopy detects most but not all polyps/cancers

Alternatives Discussed:
• Other screening methods: FIT/stool test (less sensitive, must be done annually), CT colonography (does not allow polyp removal)
• No screening: Patient informed of the risk of undetected colorectal cancer

Patient Questions:
Patient asked about the sedation used and whether he would be awake. I explained that he would receive sedation through an IV and would be comfortable and unlikely to remember the procedure. He also asked how long before he could return to work. I advised that he should take the rest of the day off but could return to normal activities the next day.

Patient Understanding:
The patient verbalized understanding of the procedure, risks, benefits, and alternatives. He was able to explain back the purpose of the colonoscopy and the main risks in his own words.

Consent:
The patient voluntarily consented to the procedure. Written consent form signed and witnessed.

Provider: [Your name]
Date/Time: [Today]

High-Risk Consent Conversation: Elective AAA Repair

Patient: 73-year-old male
Procedure: Elective open or endovascular abdominal aortic aneurysm repair
Aneurysm size: 5.8 cm (threshold for repair is 5.5 cm in men)

Pre-Conversation Assessment:

Decision-Making Capacity:
• Patient is alert and oriented
• Able to understand information presented
• Able to weigh options and express preference
• No evidence of cognitive impairment
• Family member/support person present: [Yes/No, who]

Consent Conversation:

OPENING:
"This is a big decision, and I want to make sure you have all the information you need. We're going to take our time. There's no pressure to decide today, and if you want a second opinion, I encourage that."

THE PROBLEM:
"You have an aneurysm, a bulge in your main artery, the aorta. At 5.8 cm, it's large enough that the risk of rupture is significant. If an aneurysm this size ruptures, it's usually fatal. The goal of surgery is to fix it before that happens."

WITHOUT SURGERY:
"If we do nothing, the aneurysm will continue to grow. At your size, the annual risk of rupture is around 5-10%. That risk goes up as it gets bigger. Most ruptured aneurysms are fatal before patients reach the hospital."

THE SURGERY OPTIONS:

"You have two surgical options:"

1. Open repair:
"Traditional surgery. We make an incision in your abdomen, clamp the aorta, and replace the damaged section with a synthetic graft. It's a proven procedure, done for decades."
• Hospital stay: 7-10 days typically
• Full recovery: 2-3 months
• Durability: Excellent long-term results; rarely needs revision

2. Endovascular repair (EVAR):
"Less invasive. We go through arteries in your groin and place a stent graft inside the aneurysm to reinforce the wall. No big incision."
• Hospital stay: 2-3 days typically
• Full recovery: 2-4 weeks
• Trade-off: Requires lifelong surveillance imaging. About 20% of patients need another procedure eventually.

"Based on your anatomy and overall health, you're a candidate for either approach. We can discuss which might be better for you."

RISKS OF SURGERY:

"This is major surgery with real risks. I want to be honest with you."

Mortality (risk of death):
• Open repair: approximately 3-5% for elective surgery at experienced centers
• EVAR: approximately 1-2% in the short term (but some long-term risk with re-interventions)

"To put this in perspective: the risk of dying from surgery is lower than the risk of the aneurysm rupturing over the next few years."

Major Complications:
• Heart attack: Your heart will be stressed during surgery. We'll improve your cardiac status beforehand.
• Stroke: Rare but possible.
• Kidney injury: The aneurysm is near your kidney arteries. Some patients have temporary or permanent kidney problems.
• Bowel complications: Rare, but can occur with open surgery.
• Paralysis: Very rare (1-2%) if blood supply to the spinal cord is affected.
• Infection: Any surgery carries infection risk.
• Blood loss requiring transfusion: Common with open repair.

"If a major complication occurs, you could end up in the ICU, need additional surgeries, or have a prolonged recovery. In the worst case, these complications can be fatal."

RECOVERY:

Open repair: "Expect to feel wiped out for weeks. You won't be lifting anything heavy for 2-3 months. Most people feel back to normal around 3 months."

EVAR: "Recovery is much faster. Most people are walking within a day or two and back to normal activities in a few weeks. But you'll need CT scans regularly for the rest of your life to make sure the graft is still working."

ALTERNATIVES:

1. Watchful waiting: "We could monitor it with imaging every 6 months. But at this size, I can't recommend that. The risk of rupture is too high."

2. Risk factor management: "We should improve your blood pressure and stop smoking regardless, but it won't shrink the aneurysm or eliminate the rupture risk."

3. No treatment: "You could choose not to have surgery. If the aneurysm ruptures, it will likely be fatal. Some patients make that choice for personal or health reasons, and I'll support whatever you decide."

SECOND OPINION:
"This is a major operation. If you want another vascular surgeon to review your case, I encourage that. It doesn't offend me. This is your body and your life."

QUESTIONS:
"What questions do you have?"
[Allow extended time. These are difficult decisions.]

"Is there anything you want me to explain differently?"

"Would you like to take some time to think about this, or discuss with family before deciding?"

DOCUMENTATION:

• Procedure, indications, risks, benefits, and alternatives discussed in detail as above
• Patient demonstrated understanding by asking appropriate questions and explaining back the key points
• Patient had opportunity to involve family member/support person: [Yes/No]
• Patient offered time to consider decision: [Yes/No, patient's response]
• Patient offered second opinion: [Yes/No, patient's response]
• Decision-making capacity confirmed
• Patient voluntarily consents to proceed with [open repair/EVAR/watchful waiting/undecided pending further discussion]

Signed: [Provider]
Date/Time: [Today]

INFORMED REFUSAL DOCUMENTATION

Date: [Today]
Patient: [Name], DOB: [Date]

Recommended Treatment Refused: Colonoscopy

Clinical Situation:
Patient is a 58-year-old female with a positive FIT (fecal immunochemical test) performed as part of routine colorectal cancer screening. A positive FIT indicates the presence of blood in the stool and requires follow-up colonoscopy to evaluate for colorectal cancer, polyps, or other sources of bleeding.

Recommendation Discussed:
I recommended colonoscopy to investigate the positive FIT result. I explained:

• A positive FIT does not mean she has cancer, but it does mean we need to look further
• Colonoscopy is the best way to determine the cause and, if polyps are present, remove them
• Early detection of colorectal cancer significantly improves survival
• Untreated colorectal cancer is often fatal

Risks of Refusing Colonoscopy:
I explained the following risks of not proceeding:

• If colorectal cancer is present, it will continue to grow and spread
• Early-stage colorectal cancer is highly treatable; advanced cancer is often not
• The positive FIT increases the likelihood that something abnormal is present
• Delaying evaluation could turn a curable situation into an incurable one

"I told the patient directly: 'I'm concerned that by not doing the colonoscopy, we could miss a cancer that we might otherwise catch early and cure. I want to make sure you understand this before you decide.'"

Patient's Reasons for Refusal:
Patient expressed fear of the procedure. Specifically:
• Fear of sedation and 'not waking up'
• Fear of the prep being unpleasant
• Previous negative experience with a medical procedure (unrelated)

I acknowledged her fears and addressed each:
• Sedation complications are rare; she is healthy and low risk
• The prep is unpleasant but temporary
• I offered to discuss her previous experience and arrange for extra support

Despite counseling, patient stated she is not ready to proceed at this time.

Alternatives Discussed:
• Repeat FIT in 3-6 months: I explained this does not replace colonoscopy; a positive FIT requires evaluation regardless of subsequent results
• CT colonography: I explained this is less sensitive and, if abnormal, would still require colonoscopy
• No further testing: Patient understands this carries risk of undetected cancer

Patient Understanding Confirmed:
Patient verbalized understanding of the recommendation, the risks of refusal, and the alternatives. She stated: 'I understand you think this is serious and that I could have cancer, but I'm too scared to do it right now.'

Follow-Up Plan:
• Patient will consider the information and contact us if she changes her mind
• I will follow up by phone in 2 weeks to reassess her decision
• Patient understands she can schedule the colonoscopy at any time
• Patient instructed to seek immediate care if she develops rectal bleeding, abdominal pain, or unintended weight loss

Patient Rights Acknowledged:
• Patient has the right to refuse any recommended treatment
• This refusal does not affect her ability to receive other medical care
• She can change her decision at any time

Documentation:
This conversation took approximately 20 minutes. Patient was given written information about colorectal cancer and colonoscopy. She was not under duress and made this decision voluntarily.

Signed: [Provider]
Date/Time: [Today]

Patient signature (optional but recommended): _______________
Witness (if available): _______________