practice of Medicine
Orthopedic Surgery Toolkit
Documentation and education
Documenting patient non-compliance: a powerful defense
Non-compliance in (healthcare) is a coined term used to classify patients who fail, for one reason or another, to follow health care direction given by a professional. Among the more common problem areas are:
- Repeated failure to keep appointments
- Failure to have diagnostic testing or consultation as recommended
- Failure to comply with medication therapy
- Failure to follow medication monitoring recommendations (for example, warfarin monitoring)
In this article we discuss the prevalence of “noncompliance”, “non-compliance v patients’ right to make healthcare decisions, tempering the use of the term so as not to inaccurately label patients, assisting patients in following healthcare advice or coming up with options, and what to do when your patient refuses to sign an informed consent form.
The problem of patient non-compliance is well-documented. According to a study published by the Food and Drug Administration (FDA) and the National Council on Patient Information:1
- 14-21 percent of patients never fill their original prescription
- 60 percent cannot name all the medications they are taking
- 30-50 percent fail to follow the instructions for taking a medication
In another comprehensive compilation of research on the prevalence and incidence of patient noncompliance, Dr. Sallan Showalter summarized his findings in what he called “The No-Nonsense Summary, Incidence and Prevalence of Patient Noncompliance":2
- Patient noncompliance is pervasive
- Any patient in any practice is at high risk for noncompliance
- Clinical instinct cannot detect noncompliance
- No methodology accurately predicts which patients will and will not adhere to a treatment plan
Non-Compliance versus Patient’s Right to Make Decision Regarding Medical Treatments
It is important to recognize the difference between non-compliance and the patient’s right to refuse care. Patients have the right to make informed decisions regarding their care, including being informed of their health status, being involved in care planning and treatment, and being able to request or refuse treatment. The failure to follow treatment advice may be the result of an educated, rational and reasonable decision on the patient’s part to exercise control over their healthcare. The medical record should include documentation that the diagnosis and proposed procedure/treatments were explained to the patient and that the explanation included the patient’s prognosis without the procedure, the risks and benefits, and alternative therapies. In the absence of this documentation, it may be alleged that the patient would have elected to follow the recommended advice had they understood its importance.
What should be done if a patient refuses to sign an Informed Consent form?
The patient’s refusal to sign an informed consent form poses risk management concerns. Investigation into the reasons for the refusal should be fully explored with the patient and documented in the medical record. It is advisable to have a third party, such as the office nurse or other office professional, witness this discussion. The name of the witness and/or signature should be included in the medical record notation.
If the rationale for the refusal is due to an unwillingness to undergo the procedure or treatment plan, then the procedure or treatment should not proceed, and attempts at obtaining a refusal of treatment form should be pursued with the patient. In this instance, it is imperative that a specific notation of the discussion with patient be expressly documented in the medical record. If the reason not to sign the informed consent form is for other reasons, it is suggested that a notation indicating the patient’s reasoning be made in the medical record.
Reasonable doubt regarding the patient’s intent for refusing to sign an informed consent form may be grounds to temporarily suspend the procedure or treatment protocol.
The patient has the right to refuse care and treatment. When the patient has had the risks and benefits of the proposed treatment options explained, and his/her questions answered and then refuses to go forward with the proposed treatment plan, the conversation should be documented as an informed refusal discussion. Good documentation principles suggest the medical record reflect the need for the proposed procedure, the risks, benefits, and alternatives, the consequences of refusal that were discussed, and the reason the patient stated for the refusal.iii
The physician may ask the patient to sign an “Informed Refusal” form. In these situations, while patients generally cannot “sign away” their legal rights, their signatures on such documents may constitute valuable evidence that these discussions did in fact occur.
Strategies to Enhance Compliance
It is important to consider the reasons that patients fail to follow treatment plans and make reasonable attempts to facilitate compliance. Prevention remains the best risk management strategy.
Consider the following suggestions to enhance patient compliance:
- Explain the rationale for the treatment advice
- Allow the patient to voice any concerns they have about recommended treatments
- Suggest treatments that are reasonable, taking into account the patient’s lifestyle, finances and ability to comply
- Whenever possible, give patients the opportunity to think about proposed treatments prior to making a final decision
- Provide simple written information to patients and others who are involved in their care
- Attempt to gain agreement on the treatment plan
Document Non-Compliance/Informed Refusal Carefully notate episodes of the patient’s failure to follow the healthcare plan, avoiding any documentation that may look judgmental. An example of an adequately documented informed refusal discussion is as follows:
“A breast ultrasound has been recommended to evaluate the palpable lesion on the right breast. The patient states that her insurance “will not be effective for ninety days” and elects not to have the test done pending coverage by insurance plan. The risk of delay was discussed with the patient to include the possibility of a malignancy, and the risks of a potentially life threatening delay in diagnosis and treatment. The patient verbalizes understanding of the information provided. I have asked my staff to investigate and advise her of any financial assistance that may be available. She was advised to contact me as soon as possible if she reconsiders this decision or as soon as insurance coverage is effective.”
A sample informed refusal form can be found on the MagMutual website at www.magmutual.com or call 1-800-282-4882 and ask for Risk Management.
Educate Patients Educate patients regarding recommended treatments. Emphasize the seriousness and urgency of any recommended tests. Be cautious with reassurance as the patient may interpret this to mean that the test is not important.
Document Screening Recommendations Advise patients of preventative health screenings and document these discussions. Failure to do so could result in an allegation of a delay in diagnosis if a metastatic or potentially life-threatening condition is not detected in a timely manner.
Maintain a Reliable Clinical Tracking System Without a reliable clinical tracking system, it may be difficult to identify patients who fail to keep scheduled appointments for tests and consultations with specialists. Whenever possible, schedule referrals and follow-up appointments before the patient leave the office. If the patient refuses the test, due to financial or other reasons, this should be well documented. The patient will remain active in the tracking system until one of three potential outcomes occurs: (1) follow-up is complete; (2) informed refusal is documented, or (3) there have been reasonable attempts (usually three) to encourage patient compliance. Document all attempts to contact the patient. We advise the last attempt be in writing, clearly explaining why the follow-up is necessary, and the potential consequences of failure to do so. Mail the letter certified and/or return receipt requested.
Coordinate Treatment Plans with Other Providers Involved in the Patient’s Care Maintain good communication with others involved in the patient’s care and maintain a clear understanding of the expectations and role in the patient’s plan of care. Consultant should notify you if the patient fails to keep an appointment and should also provide periodic updates on the care and treatment plan or a summary at the conclusion of care, whichever is appropriate.
When all else fails…Terminate the Patient Physician Relationship If the physician feels that the patient’s non-compliance is putting them at risk, they may decide that it is best to end the relationship with a patient. Prior to making this decision, it is prudent to step back and evaluate whether they have done everything within reason to preserve the relationship. If the decision is made to terminate the relationship, the provider should send a withdrawal letter by certified mail, return receipt requested.
Given the extensive research on patient non-compliance, it is reasonable to maintain a high index of suspicion for non-compliance on all patients. The best approach is to maintain effective communications with patients and take proactive measures to enhance treatment goals. However, when patients fail to follow recommended advice and a poor outcome results in a medical malpractice claim, objective documentation of non-compliance can be a powerful defense.
Pre-post operative patient education
Postoperative complications are the most significant independent risk factor leading to 30-day hospital readmissions among general surgery patients according to a 2012 study published in the Journal of the American College of Surgeons1. With proper planning, patient education, and timely follow-up in the office, some postoperative complications may be prevented.
The educational process begins in the preoperative phase with the informed consent discussion and the written preoperative instructions. Included in this discussion are:
- signs and symptoms of the common known complications
- complications that are possibly less common but are serious and would warrant quick identification and intervention
- a description of what to expect during the surgical stay and the post-procedure recovery period
Document the discussion of potential complications in the patient medical record. Patients are at a greater risk for postoperative complications in the immediate postoperative time period. A study of Medicare fee-for service patient medical records revealed that nearly one in seven patients had potentially preventable adverse events that required hospital admission within a month following their procedure.2 It is important that when the patient leaves the surgical facility or is discharged home from the hospital following a surgical procedure, that the patient/caregiver receive repeat written, and individualized instructions concerning signs and symptoms of possible surgical complications. It is also important that patients know how to contact the surgeon, and the importance of the follow-up visit. Timely post-procedure follow-up in the office provides an opportunity to assess the patient for potential complications, and reinforce the education about signs and symptoms of possible complications.
Comprehensive post-operative instructions for follow-up care include these signs and symptoms, at a minimum:
- Difficulty breathing
- Fever over 100 degrees
- Difficulty or painful urination, inability to empty bladder
- Black, tar-like stools
- Jaundice (yellow tint to eyes or skin)
- Pain that sharply increases, or becomes uncontrollable
- Wound drainage problems; redness, foul odor from drainage, bleeding or opening at the incision site
- A decrease in ability to function (ex: cannot walk)
- A change in level of consciousness or ability to wake
- Persistent diarrhea, constipation, nausea, or vomiting
- Inability to tolerate food or drink
- Unexplained leg pain in one or both legs
- Difficulty swallowing
- Call 911 in an emergency
Ask the patient/caregiver to sign an acknowledgement that they have received written postoperative instructions, and place a copy in the medical record. In order to facilitate postoperative care, a copy of the patient instructions should be sent to the surgeon’s office medical record.
The National Patient Safety Foundation (NPSF) publishes four post-discharge tools for patients. Providers may copy and provide to patients. These may be found at www.npsf.org/for-patients-consumers.
Patient information booklets
A good patient information booklet saves office time and creates goodwill. Such a booklet will not replace the Notice of Privacy Practices physicians must provide to patients under the HIPAA privacy rules, but may be used in conjunction with the Notice. Booklets can provide written guidelines for staff and patients and can reduce the number of incoming telephone calls. There is no one correct way to put the booklet together. Each office is the best judge of what kind of format suits the physician’s character, specialty and practice.
The following guidelines should help. Remember to keep the topics short and direct. The booklet is merely introducing the physician’s practice. The staff and patient care will complete the picture.
- Introduce the physician and staff and give the credentials or general functions of each person.
- Encourage complete openness and honesty with the physician and staff to facilitate quality healthcare. Assure the patient that communications are confidential.
- Describe the physical layout of the office and parking facilities. Indicate if the patient should allow extra time to find a parking space and whether or not the office validates parking receipts.
- Tell the patient about any special amenities such as childcare, coffee, tea or soft drinks.
- Describe the type of practice and its benefits. If the physician sees only referrals, say so.
For a group practice, explain that the patient will receive medical care even when his/her physician is absent.
- Give the office hours, holidays, after-hours and weekend coverage.
- Discuss the policy on emergencies.
- Be explicit about appointments. Let patients know how far in advance they should call, and provide the office policy on “walkins?”
- Tell patients to cancel appointments as far in advance as possible and whether or not the office charges for missed appointments.
Encourage patients to describe their problems to the staff when making an appointment. Explain that this is to facilitate convenient scheduling for both the office and patients.
- Explain the importance of being on time so patients will not experience long waiting periods. However, if your office has a history of being late for appointments, do not encourage patients to be prompt. This only creates hostilities when patients comply and the office is not ready for patients at the appointed time.
- Explain telephone procedures so patients know what to expect when calling about a medical condition.
- Explain the method of payment most preferred by the office (monthly billing, payment at the time of visit, etc.). Talk about the patient’s responsibility to pay for services rendered and overdue bills.
- Describe the office’s policies on handling insurance forms (who is ultimately responsible for payment, and who will file all claims). If there is a fee for this service, list the fee.
- Collect staff suggestions since employees are familiar with common patient questions/problems.
- Personalize the content with the “you” form of address.
- Use the largest typeface possible to improve readability and design a pleasing layout.
- Include a map and directions.
- Budget for a six-month supply so revisions can be made frequently.
- Give the booklet as a reference guide to all patients, both established and new.
- Take the patient’s point of view when putting the booklet together.
- Thank the patient for choosing the physician’s office.
Other Suggested Topics:
- Charges for telephone consultations.
- Notification of lab results.
- Answering service.
- Prescription refills.
- Call backs.
- Whether the office has special times for scheduling appointments.
- Emergency phone number and what procedure to follow.
These suggestions can help an office get started in producing an information booklet suitable for the practice.
Some offices have found it helpful to prepare a patient information letter outlining selected information.
Other practices have created attractive brochures along the same lines. The objective is to create an informational tool that represents the philosophy of the office.
Through good communication, the office can establish an improved physician/patient relationship and enjoy a smoother-running practice, more-effective staff and happier patients. Patients will not only be satisfied with their medical care but also with the physician’s thoughtfulness and management abilities.
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.