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INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C) June 18, 2015 NYRC 1095 W. Pender Street, Suite 1385 Vancouver, BC V6E 2M6 Phone: (778-372-1410 Fax: 778-372-1411
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INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

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Page 1: INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

INFORMED CONSENT PROCESS

Pan Am Para/Pan Am Games

TO2015 WEBINAR

Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

June 18, 2015

NYRC

1095 W. Pender Street, Suite 1385

Vancouver, BC V6E 2M6

Phone: (778-372-1410

Fax: 778-372-1411

Page 2: INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

My qualifications • President of NYRC Corp; BC.; registered Chiropractor in Ontario and BC

• Fellow in Chiropractic Sports Sciences, Rehabilitation and Orthopaedics

• Associate Professor at CMCC since 1989 ; 26 years of teaching experience

• Participant in the IBC webcast Sept 03

• Credentialed by the Canadian Academy of Pain Management (CAPM)

• Past President of the Canadian Society of Chiropractic Evaluators

• Board member of the Canadian Society of Medical Evaluators

• Past President of the Association of Independent Assessment Centres (AIAC)

• Certified in the 4th and 5th editions of the AMA Guides on Impairment rating and has training in the 6th edition

• Involvement in the new Auto Ins Reg. Changes Sept 2010

• Stakeholder participation in Roundtable CAT determination discussion

• Member of the Superintendant’s Reform Implementation Steering Committee (RISC)*

• Member of FSCO Licensing implementation working group

• Member of the Whistler Medical Team for VANOC 2010 Winter Olympic Games

• Successfully completed all 6 semester courses from the University of Montreal in “Medecine d’assurance et d’expertise”.

• Coordinator of the CSCE/CMCC Catastrophic course – AMA Guides certification program since 2007

• Lead Medical Practitioner (Golf) – TO2015 Pan Am Games

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OUTCOMES OF WEBINAR – JUNE 18, 2015

• Review Pan Am/Para Pan Am games consent

form and policy

• Review the Informed Consent Process

• Review the what, when, where, how and why…

of Informed consent

• Review documentation of Informed Consent

• Review some clinical cases

• Q and A

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Whistler Day 1

• Athlete’s Village

• Whistler

• Polyclinic

• Venues

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The Excitement at Major Games

• Wow, What an experience!

• Fast – paced

• Think quickly

• Highlight in one’s

career

• “Living the dream”

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Let’s review the Informed Consent Process

• Major games : obligations and requirements are

fundamentally the same; just done differently

• What’s different? : documentation of process

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TO2015 Consent Form

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TO2015 Consent Form

• This consent form has been developed by the CMO,

Ministry of Health and Legal counsel

• This is the only form that is to be used in the consent

process; to be used by all Health Practitioners

• No other forms are authorized to be used at the TO2015

Pan Am/Parapan Am games

• This form is to be signed, once by the credentialed

TO2015 Athlete at their first medical encounter

• This covers medical services and health information

sharing

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TO2015 Consent Form

• Expressed Consent - This document will

provide consent for medical care by any of our

practitioners and will allow information sharing

within the circle of care and to the insurance

carriers, ADP program and other Games

stakeholders as appropriate

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Page 10: INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

TO2015 Consent Form

• Implied Consent - If an individual practitioner

would like additional consent for a specific

treatment, they will proceed with the explanation

of procedure and inform the patient of any risk or

potential adverse event. They will obtain verbal

consent and then implied consent through the

patients participation in treatment.

• It is expected that the practitioner will document

the consent process and the patient’s

agreement in the electronic or paper chart

(Informed consent)

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Informed Consent : For all Healthcare Practitioners In this Webinar: patient consent to examination and treatment, complications of spinal manipulative therapy (SMT), contraindications to SMT, and case studies will be reviewed. PATIENT CONSENT TO TREATMENT (INFORMED CONSENT) under common law in Canada, for many years it has been mandated that a health care practitioner must obtain the consent of a patient for any assessment or treatment to be performed by the practitioner

•informed consent does not just involve just signing a form IT IS A PROCESS Traditionally there has been 5 Steps to ensure Consent is “informed”: New recommendations have emerged in the past 5 years!

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5 Basic Steps to Informed Consent

1) explain to the patient the recommended treatment

2) explain why they should have the treatment (benefit)

3) discuss alternative(s) to having the treatment

4) discuss effects, risks, side-effects of the treatment

5) explain what may happen if the patient does not have the treatment (natural history)

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Diagnosis*

• Even though it is not one of the 5 steps of the

Informed consent process, it is implied that the

Diagnosis be reached before treatment is

discussed; is communicated to the patient

properly; is in case law and is now in the latest

CCPA communication

• * New

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Elements of Consent

• Fully informed

• Voluntarily given

• Related to the patient’s condition and circumstance

• Not obtained through fraud or misrepresentation

• Evidenced in a written form, signed by the patient OR documented in patient record

• Can be withdrawn at any time

• See www.cco.on.ca

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When should Informed Consent be

Obtained at TO2015 games?

• When a chiropractor assessing a new

condition and/or starting new treatment at

TO2015 Pan Am/Para Pan Am games!!

• Athlete presents with a new condition

• Athlete’s general health status changes

• You decide to change their treatment

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Documentation : The How

• After you explain the athlete’s condition, your

plan of management and associated risks….

• Document this : “Informed consent Obtained” in

the EMR, SOAP notes for that day. Witnesses?

• Document if there were any comments,

questions, concerns from athlete in EMR

• No form, no signature, … Just follow the process

and document it!!

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Documentation : When? Where?

• Athlete Encounter: Before, during and after

game time…

• During game time : first aid and decide “Play or

get off the field? (Consent)

• Different venues : Field of play, polyclinic,

medical tent…

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Communication of Material Risk : Treatment

•involves any health care practitioner’s knowledge of any possible adverse serious effect(s) of a treatment on a patient

•Should be relevant to the condition being treated and the type of treatment recommended

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Relevant : Risks and Side Effects

of Assessment/Treatment

• Do we need to warn of risk of stroke with our

chiropractic assessment? NO

• Do we need to warn risk of stroke with

“Myofascial Release technique” in the neck? NO

• Do we need to warn risk of stroke with treatment

of “golfer’s elbow” – no SMT? NO

• Do we need to warn of cauda equina syndrome

if SMT is Rx. in LDH case? YES

• Do we need to warn of cauda equina syndrome if SMT is

Rx. in Lumbar Facet Syndrome case? NO

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COMPLICATIONS OF SPINAL MANIPULATIVE THERAPY (SMT) : Literature

•serious complications of SMT are presented primarily in case reports and the 2 most frequently reported complications are:

vertebrobasilar accidents (VBAs) cauda equina syndrome (CES)

•295 complications of spinal manipulation from the literature:

165 VBAs 61 cases with disc herniation led to CES 13 cerebral complications other than VBAs 56 other

•average age of patients with VBA is 38 years

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Complications from Manual Therapies – adverse events

Symptoms Dizziness or vertigo

Increased pain or stiffness*

* Most common

Musculoskeletal Strain/sprain

Fracture

Disc Herniation (aggravation)

Circulatory Vertebral artery injury

Carotid artery injury

Neurologic

Nerve root compression

Spinal cord injury

Posterior circulation stroke

Cauda Equina Syndrome

Cord Compressive Myelopathy

(aggravation)

Page 22: INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

CONTRAINDICATIONS TO SPINAL MANIPULATION Absolute Contraindications to SMT (Red Flags) acute arthropathies Eg. AS, RA acute fractures or dislocations signs of ligamentous rupture or instability malignancy or metastasis infections of bone or joints acute myelopathy cauda equina syndrome

Page 23: INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

Relative Contraindications to SMT

spondylolisthesis with progressive slippage - articular hypermobility

post-surgical Spinal joints

osteoporosis

benign bone tumours

clinical manifestations of VBI (vertebrobasilar infarction)

aneurysm

anticoagulant therapy, e.g., heparin, coumadin

blood dyscrasias, e.g., hemophilia

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Probable Contraindications to SMT history of significant trauma – dangerous mechanism of injury

fever greater than 100F history of prolonged corticosteroid use ( bone density) unexplained weight loss history of cancer adenopathy treatment of serious systemic inflammatory arthritides or vasculotides endocrinopathy ex. metabolism of calcium neurological deficit present (cautious)

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Other Contraindications to Manual Therapies

• Psychiatric disorders

• Vascular disorders

• Intoxication

• Anticoagulation or antiplatelet medication

• Previous stroke

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The How, When and Why….

• Now let’s review the how and when you review

consent with your patient in order for it to be

deemed “Informed Consent”.

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Getting to know your Athlete : Quickly

• Past Medical history : Surgeries, illnesses,

Meds….?

• Any contraindications to SMT?

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The What and the When….

Besides the 5 steps already discussed:

a) What needs to be disclosed : the risks and even

diagnosis,

b) Timing of the informed consent process –

before and after physical examination

c) You must discuss with the patient each material,

unusual or special risk and be satisfied that the

patient appeared to understand those risks and

note that fact on the patient’s chart”

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Patient Understanding

• “If a patient does not ask questions, the

chiropractor cannot assume that the patient

understands the various risks”.

• Chiro should not just ask Patient, “any

questions”?

• Use “teach back” method

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Dr. Dean Wright, DC

Executive Claims Officer

Canadian Chiropractic Protective Association (CCPA)

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We are excited for DC’s to participate on the

healthcare team

We are a silent partner

We are there to support you

We want this to be a positive experience

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Regardless of profession there is only one standard for informed consent

A patient’s right; a doctors responsibility

Done properly, it improves communication between the patient and the doctor

Informs the patient

Protects the doctor

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Have a copy of the CCPA informed consent (IC) document for easy reference

Verbally address only the relevant sections with the patient

Clearly document that IC has been obtained in ER, make note that you referenced the CCPA IC document

Do this consistently and you enhance your level of protection

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Case Study #1 - Medicolegal :

• Mr. F. a 47 year old accountant presented to a chiropractor in Niagara on

the Lake initially on or about June 11, 2008. He presented with excruciating

back pain radiating into his left leg. He had just traveled from Toronto and

was sitting, having business meetings with his partners. He reported a

prior history of lumbar disc herniation .

• .Mr. F. states that he did not know the risks of chiropractic management,

even though he signed the consent form. It does indicate the rare

reported cases of disc injury following spinal manipulation. Nevertheless,

Dr. Chiro’s initial form of treatment recommended was acupuncture and

active release technique.

• He has also had successful treatment of his back pain and sciatica from his

chiropractor who performed spinal manipulative therapy a year prior.

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Medicolegal Case Study :

Informed Consent .

• “Reportedly, Dr. Chiro did not review the risks verbally with Mr. F. however,

they were presented to him, which Mr. F. acknowledged. Although this is

not optimal, is this an acceptable form of communication of the risks of

spinal adjustments?

• Lesson Learned : Informed Consent is a process and review of the

risks of treatment should be done with the patient and allow them

an opportunity to respond and ask questions.

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Case Study #2 - Olympic Games

• 44 YO Female RCMP Officer jumped over 2 barricades (2 ft) (Jan 15, 2010) and landed funny on L knee, heard a “pop”, went down and could not weight-bear

• Laid there for 15 min, no feeling in ant knee, burning still

• X-ray – N

• Dx- “Knee is twisted”

• Worked 8-14 hour shifts in Whistler Winter Olympic Games 2010

• Physio, RMT, Chiro- No Help

• Obs - ?

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Olympic Games Case Study (Cont’d)

• L knee ROM – Flex-90, Ext lag -10

• L Thessaly +ve, joint-line tenderness

• L Ant Drawer +ve, R-side N, L Lachman’s +ve

• MCL, LCL and PCL intact and stable

• L pivot shift –ve, tender L tibial plateaus

• Dx ??

• Rx ??

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Olympic Games Case Study (Cont’d)

MRI – Feb 22, 2010

• complete tear of L ACL

• Mild tear of L MCL

• Impaction fracture of lateral tibial plateau!

• Meniscii – N

• RX ??

Page 39: INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games … · INFORMED CONSENT PROCESS Pan Am Para/Pan Am Games TO2015 WEBINAR Rocco Guerriero B.Sc. DC, FRCCSS(C), FCCPOR(C), FCCOS(C)

Clinical Pearl

• What are the Ottawa Knee Rules?

• Thessaly’s test can give you false positives..

What is its’ validity?

• Prominence along the lateral joint line is

typically.. What? Not necessarily in this case

• Further diagnostic imaging is essential in the

proper diagnosis of certain cases, such as this

one!

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Summary : Informed Consent

• Working as a chiropractor in a major games is fast-

paced and exciting for all!

• This does not lessen your obligations as a Health

practitioner in obtaining informed consent

• Informed consent “process” is still essentially the same;

but done differently in major games…

• Document your “Informed consent encounter” in the

EMR in SOAP notes. Note if any witnesses.

• Have fun … Let the games begin!

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Contact

• If you have any questions now or during games,

feel free to contact me :

[email protected]

• Cell : 416 574 1427

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Questions and Answers

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