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Patient Non-Compliance. Rob Walters Resident Grand Rounds October 30, 2001. Strike One. Case Presentation. Definition. Patient non-compliance is the patient’s breach of an agreement between himself and his healthcare provider.*. * I made this up.

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Patient Non-Compliance

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Patient Non-Compliance

Rob Walters

Resident Grand Rounds

October 30, 2001

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Strike One

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Case Presentation

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Patient non-compliance is the patient’s breach of an agreement between himself and his healthcare provider.*

* I made this up.

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You really shouldn’t call it non-compliance.*

The term ‘compliance’ suggests an excessively authoritative role for the provider; ‘adherence’ is a more acceptable term often used in the literature.

* I’m gonna do it anyway.

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side effects











Causes of non-compliance

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We all know it’s out there.

  • Estimated non-compliance with drug regimens is 50%.

  • In low-income populations, it exceeds 60%.

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Risk Factors

  • limited education

  • minority race

  • tobacco abuse

  • youth (age <40)

  • limited medical history

  • multiple providers

  • cultural and language barriers

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Why try to improve compliance?

  • To address a very prevalent problem

  • To reduce patient morbidity and mortality

  • To reduce overall healthcare expenses

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Horwitz et al. - Methods

  • Used data from the Beta-Blocker Heart Attack Trial (BHAT) in which patients were randomized to receive propranolol or placebo after sustaining an MI and then observed for its effect on mortality.

  • They selected 2,175 male patients who had adherence and psychosocial data available.

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# Pills Taken

# Pills Prescribed

Horwitz et al. - Methods

  • Patients were evaluated every three months for an average of 25 months. At each visit, compliance was assessed by pill counts.

  • Compliance =

  • Good compliance was defined by >75% of prescribed pills taken.

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Horwitz et al. - Results

Patients who died within one year after myocardial infarction were 2.5 times more likely to have been non-compliant with their medical regimen.

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Horwitz et al. - Results

Results held true:

  • after adjustment for clinical and psychosocial factors such as severity of the infarction, presence of heart failure, tobacco use, high life stress, and social isolation

  • for both propranolol and placebo treated patients

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Horwitz et al. - Conclusions

Non-compliance is an independent risk factor for mortality is this setting.

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Horwitz et al. - Limitations

  • Possible susceptibility bias - Patients doing poorly may have been less complaint.

  • Study design

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My wife is a lawyer!

  • Physicians have a duty to provide the standard of care.

  • Patients have the right to refuse recommendations.

  • When non-compliance leads to bad outcomes…

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Sample Lawsuits

  • The patient refused proper turning and timely debridement… $175,000 for pressure ulcers.

  • The patient didn’t show up for her mammogram… now suing for failure to diagnose breast cancer.

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Legal Advice

  • When patients refuse recommendations, the provider should document this clearly.

  • When patients fail to follow up for a recommended intervention or evaluation, the provider should attempt to contact the patient and document this effort.

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simplify the treatment plan

patient and provider education

patient and provider reminders

assign priority to recommendations

directly observed therapy

financial incentives


transdermal medications

meal planning

What can we do about non-compliance?

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Raynor et al. - Study Design

A randomized controlled trial to assess the effect of printed medication schedules on patient compliance with their medications.

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Raynor et al. - Methods

  • 210 general medical patients were recruited; they were required to be able to take medications independently.

  • Patients received counselling from either a pharmacist or nurse and either a reminder chart or not at the time of discharge.

  • Pill counts were conducted 8-12 days later.

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Raynor et al. - Medication Chart

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NCBH Medication Chart

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Raynor et al. - Results

  • The average compliance score for patients receiving a reminder chart was 86% compared to 47% for those without a chart (p<0.001).

  • A significant difference in compliance was detected only on the basis of whether they had received a reminder chart.

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Raynor et al. - Limitations

  • Investigators were not blinded.

  • Reviewed by Drs. Moran and Wofford

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Lowe et al. - Study Design

A randomized controlled trial to assess the effect of an inpatient self-medication program on patient non-compliance with medications.

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Lowe et al. - Methods

  • Recruited 88 consecutive admissions to medical wards “with an interest in elderly patients.”

  • A pharmacist reviewed the medical regimen with the team to simplify it as much as possible.

  • Patients were randomized to standard care or the self-medication program.

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Lowe et al. - Methods

The self-medication program:

  • First, nurses on usual medication rounds gave patients a box containing their medications in typical prescription bottles and observed the patient, intervening only if the patient was about to make a mistake.

  • Second, patients were expected to ask for their medications at appropriate times, and nurses intervened if patients were more than a half-hour late.

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Lowe et al. - Methods

The self-medication program:

  • Finally, the patients kept their own medications, and nurses intervened only to conduct a daily pill count.

  • The authors reported that overall nursing time required for the self-medication program was roughly equivalent to that required for standard care.

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Lowe et al. - Methods

  • Patients were discharged with a 14-day supply of medications and a reminder chart.

  • Patients were seen at home 10 days after discharge. They were asked to turn over all of their medicines and then given a replacement supply. The investigators conducted a brief survey and a pill count was done later.

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Lowe et al. - Results

  • The compliance score for the self-medication group was 95% compared to 83% in the control group (p<0.02).

  • These relatively high scores were thought to relate to the pharmacist intervention and reminder charts given to all patients.

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Lowe et al. - Limitations

  • Investigators were not blinded.

  • These methods may be impractical in direct application, as most patients capable of participating in this study would probably be discharged from NCBH. The principles may be more applicable in a home health setting, but also more expensive.

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Eisen et al. - Study Design

A prospective cohort study of 112 VA clinic patients with hypertension being treated with once, twice, or three times daily medications to assess the relationship between dosing frequency and compliance.

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Eisen et al. - Methods

Patients were given electronic pill containers that recorded times when medications were removed. Compliance information was gathered monthly.

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Eisen et al. - Results

  • Using a standard pill count method, only the tid medications differed significantly with 84% compliance compared to 96% and 93% for qd and bid, respectively (p<0.05).

  • However, measuring the percent of days that the prescribed number of pills were taken showed 84%, 75%, and 60% compliance for qd, bid, and tid medications respectively; each was significantly different.

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Eisen et al. - Results

  • The following characteristics were significantly associated with compliance: higher income, beyond elementary school education, living alone, and being employed.

  • The authors concluded that the standard pill count methods underestimate actual compliance.

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Eisen et al. - Limitations

  • The study is limited in strength by the narrow population base and the prospective cohort design.

  • The authors failed to include blood pressure control as an endpoint; this would have enhanced the clinical value of the study substantially.

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Bodiya et al. - Study Design

A randomized controlled trial to assess the effect of telephone reminders on patient compliance with obtaining mammograms.

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Bodiya et al. - Methods

  • 298 patients at a family practice group who had a normal mammogram the previous year were randomized to receive no reminders, a reminder letter one month prior to the mammogram, or a reminder letter and a phone call if no mammogram was obtained within 8 weeks of the due date.

  • Practitioners were unaware of the study.

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Bodiya et al. - Results

  • At eight weeks (prior to the phone calls), there were no significant differences in compliance between the groups.

  • Six weeks after the phone calls, compliance rates were 34%, 36%, and 57% respectively, demonstrating a significant difference with the phone call intervention (p<0.005).

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Bodiya et al. - Limitations

  • small sample size

  • one practice setting

  • population limited to those that had mammograms the previous year

  • limited follow-up period

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Miller et al. - Study Design

A randomized controlled trial to assess the effect of providing postage for Hemoccult packets on patient compliance with returning the cards.

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Miller et al. - Methods

  • Hemoccult packets were prepared in advance such that 50% included postage on the return envelope.

  • The packets were distributed per routine to 325 patients of Duke University Medical Center clinics .

  • Two months were allowed to return the cards.

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Miller et al. - Results

  • Among indigent patients, 77% of postage-paid packets were returned compared to 56% of unstamped packets (p<0.006).

  • There was no significant difference in return rates among privately insured patients.

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Miller et al. - Limitations

  • The study was conducted at only one medical center.

  • It was Duke University Medical Center.

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Enough with the evidence already. How about some…Philosophical Guidelines

  • Establish a strong patient-provider relationship.

  • Talk to the patient about adherence. Ask if the treatment plan is one they are willing and able to follow. On follow-up, ask if the patient has been able to adhere to the plan.

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Philosophical Guidelines

  • Involve the patient in formulating the treatment plan and offer choices in management.

  • When confronted with a non-compliant patient, you must work within the bounds set by negotiation with the patient. If you cannot accept these conditions, you should arrange another provider for the patient.

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Philosophical Guidelines

  • Do not let a history of non-compliance affect your decision making; these patients deserve a chance at proper care. On the other hand, active non-compliance is cause to modify your treatment of the patient.

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Case Study:Working with Non-Compliance at DHP

  • An automated telephone appointment reminder system

  • Completing missed appointment cards

  • When necessary, contacting patients by phone, mail, certified mail, or even police escort

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Working with Non-Compliance at DHP

  • Limited provision of return postage for Hemoccult cards

  • Limited ability to produce an automated medication list

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  • Patient non-compliance is a prevalent and costly problem.

  • Physicians must address non-compliance actively both to improve patient care and to avoid liability.

  • Evidence exists supporting various methods for improving compliance.

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  • Peter Lichstein

  • Robert Jones(DHP Administration)

  • Tara Maples(Pharmacy)

  • Rhonda Warner(Risk Management)

  • And special thanks to...

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All Done !

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