SummarySan Francisco General Hospital used visual medication schedules and brief teach-back protocols in English, Spanish, and Cantonese to improve anticoagulant control among low-literacy patients in the public hospital's anticoagulation clinic. The computer-generated visual medication schedules provided digitized color images of a patient's prescribed regimen of warfarin (a drug commonly used to achieve anticoagulation control) on a weekly calendar, using universal symbols to signify the dosing schedule along with written instructions in English and Spanish or Cantonese as appropriate. The three-part teach-back protocol first described the updated dosage, asked the patient to repeat the dosing schedule, and corrected any misunderstandings. The intervention reduced the time to achieve target anticoagulation control among participants, with time differences substantially greater for non-English speakers than for English speakers.Strong: The evidence consists of a systematically designed randomized clinical trial of chronic warfarin users in which efforts were made to ensure an even distribution of languages in the intervention and control groups. Extensive demographic and clinical data were collected to ensure that any group differences were also taken into account.
Developing OrganizationsSan Francisco General Hospital; University of California, San Francisco Center for Vulnerable Populations
Date First Implemented2002
Race and Ethnicity > Asian; Hispanic/latino-latina; Vulnerable Populations > Non-english speaking/limited english proficiency
Problem AddressedSuccessful anticoagulant care involves numerous medication dosage adjustments and administration schedules that may vary from day to day and month to month. This complexity, combined with the limited time available during the typical clinical encounter, can often result in misunderstandings between clinicians and patients regarding medication, which in turn can lead to many patients not receiving the full benefit of the therapy.1
- Significant patient/provider discordance: Previous studies report rates of discordance between patients and clinicians concerning warfarin administration regimens at nearly 50 percent in general, with higher rates for patients with limited English proficiency and inadequate health literacy.2
- Increased risk of serious complications: Medication errors caused by this discordance may prevent patients from receiving the full therapeutic value of the drug and place them at risk for serious, preventable complications such as stroke (if under-anticoagulated) and bleeding (if over-anticoagulated).3
- Provider communication can help: Studies suggest that rigorous reviews of medication regimens during patient visits, augmented with visual aids, can help to reduce discordance rates and prevent the negative health consequences associated with medication errors.3
Description of the Innovative ActivitySan Francisco General Hospital used visual medication schedules and teach-back protocol to help patients with limited English proficiency and poor anticoagulation control better understand their warfarin dosing regimen, with the goal of achieving better anticoagulation control. Key elements of the project include the following:
- Patient enrollment: Patients were asked to participate if they met the following criteria: (1) they were being seen in an anticoagulation clinic; (2) they were at least 18 years of age; (3) they spoke fluent English, Spanish, or Cantonese; (4) they reported being on warfarin; and (5) their anticoagulation control was poor, as suggested by an international normalized ratio outside the target therapeutic range. Project leaders randomly assigned eligible patients to intervention and control groups.
- Visual medication schedules: Each intervention group participant received a visual medication schedule, a single piece of paper including digitized images of the patient's warfarin regimen on a weekly calendar. The words were printed in English and, if appropriate for the patient, in Spanish or Cantonese as well. The hospital used software developed by an external company to create the visual medication schedules to hospital specifications.
- Teach-back protocol: After describing the updated warfarin dose illustrated on the visual medication schedule, a research associate asked each intervention patient to repeat the dosing schedule, and, if necessary, corrected his or her understanding one time only. The teach-back method was designed to reinforce the visual medication schedule in a manner that approximates how a typical clinician would interact with the patient, serving as a "double check" to make sure that the patient does not misinterpret the medication schedule, leading to potential harm.
- Consultation and medication management: Patients using the visual medication schedule also received standard medication counseling and followup in the anticoagulation clinic by pharmacists with expertise in this area in a fashion identical to the control group.
Context of the InnovationSan Francisco General Hospital is a licensed 598-bed general acute care hospital within the Community Health Network, which is owned and operated by the City and County of San Francisco, Department of Public Health. It is affiliated with the University of California, San Francisco, and is home to more than 20 University research centers, affiliated institutes, and major laboratories. San Francisco General Hospital provides a full complement of inpatient, outpatient, emergency, skilled nursing, diagnostic, mental health, and rehabilitation services for adults and children. The hospital's outpatient anticoagulation clinic serves an ethnically and linguistically diverse set of patients who are typically of low socioeconomic status. When locally generated, practice-based research demonstrated high rates of medication discordance and adverse medication-related events in the anticoagulation clinic, researchers with the University of California, San Francisco Center for Vulnerable Populations decided to test a visual medication schedule and teach-back intervention with eligible clinic patients.
ResultsResults from a randomized clinical trial of 147 chronic warfarin users found that the visual medication schedules combined with teach-back reduced the time to achieve target anticoagulation control for patients who did not adhere to their prescribed regimen at the start of the trial.2 Moreover, non-English speakers appear to have benefited disproportionately from the intervention.
Strong: The evidence consists of a systematically designed randomized clinical trial of chronic warfarin users in which efforts were made to ensure an even distribution of languages in the intervention and control groups. Extensive demographic and clinical data were collected to ensure that any group differences were also taken into account.
- Anticoagulation control achieved more quickly: Intervention subjects who were discordant at baseline achieved anticoagulation control nearly twice as quickly as control subjects who were discordant at baseline, with median time to anticoagulation control for intervention subjects 28 days versus 49 days for control subjects.
- Greater difference among non-English speakers: Median time differences between intervention and control groups, not considering medication concordance at baseline, were substantially greater for non-English speakers than for English speakers (Spanish: 33 days for intervention group compared to 53 for control; Cantonese: 29 days vs. 36 days; English: 40 days vs. 42 days).
Planning and Development ProcessKey steps in the planning and development process include the following:
- Establishing partnership with software company: The hospital partnered with a software company to create visual medication schedules.
- Modifying the software: Project leaders tailored the software to meet hospital specifications, designed to address the specific needs of clinic patients.
- Training staff: Research associates received formal training on assessing patients for concordance using a visual cue, as well as entering information into the program's software in order to generate new visual medication schedules. Project leaders also worked together with research associates to develop a script for the teach-back protocol.
Resources Used and Skills Needed
- Staffing: Over the course of the study, four research associates implemented the intervention with patients, supervised by two project leaders who were already affiliated with the University of California, San Francisco.
- Costs: Beyond the costs of the software, the only additional costs included the color printer, ink, and staff trainings.
Funding SourcesAgency for Healthcare Research and Quality; American Heart Association; National Center for Research Resources; Hellman Early Career Research Award; University of California, San Francisco Academic Senate
Getting Started with This InnovationIncorporate intervention into staff education: When initiating this intervention, it is important to integrate it into a larger staff training or educational initiative regarding medication-related counseling and patient safety.
Sustaining This Innovation
- Get and maintain hospital buy-in: To sustain this effort, it must become a hospital priority. Keep hospital leadership informed and engaged to encourage continued support.
- Continually check in with clinicians: Provide ongoing support and guidance for clinicians involved in delivering the intervention. In particular, ensure that clinicians remind patients to bring their visual medication schedules along with them to appointments.
- Encourage the wide use and acceptance of visual medication schedules: Promote the use of visual medication schedules as a Joint Commission on the Accreditation of Health Care Organizations requirement/standard.
Spreading This InnovationSan Francisco General Hospital's anticoagulation clinic has adopted visual medication schedules combined with teach-back as the standard of care. Project leaders from the initial pilot study conduct in-service trainings on best practices with pharmacy staff and residents approximately once per year.
Additional ConsiderationsIt is possible that the software will need to be continually updated because of the high rates of newer generic forms of warfarin that are not represented in the digital images. It also may be challenging to ensure that accurate up-to-date doses of warfarin are reflected in the visual medication schedules provided to patients (i.e., medication reconciliation across providers).
Contact the InnovatorDean Schillinger, MD
UCSF Professor of Medicine in Residence
Director, UCSF Center for Vulnerable Populations
Bldg 10, 3rd floor San Francisco General Hospital
1001 Potrero Avenue
San Francisco, CA 94110
Phone: (415) 206-8940
Fax: (415) 206-5586
Edward Machtinger, MD
Associate Clinical Professor of Medicine
Director, UCSF Women's HIV Program
University of California, San Francisco
San Francisco, CA 94143-0320
Innovator DisclosuresDr. Schillinger and Dr. Machtinger have not indicated whether they have financial interests or business/professional affiliations relevant to the work described in this profile; however, information on funders is available in the Funding Sources section.
References/Related ArticlesSchillinger D. Genetics of warfarin response. N Engl J Med. 2008 Jun 19;358(25):2741-2; author reply 2743-4. [PubMed]
Schillinger D. Misunderstanding prescription labels: the genie is out of the bottle. Ann Int Med. 2006 Dec 19;145(12):926-8. [PubMed]
Schillinger D, Wang F, Rodriguez M, et al. The importance of establishing regimen concordance in preventing medication errors in anticoagulant care. J Health Comm. 2006 Sep;11(6):555-67. [PubMed]
Schillinger D, Machtinger EL, Wang F, et al. Language, literacy, and communication regarding medication in an anticoagulation clinic: a comparison of verbal vs. visual assessment. J Health Comm. 2006 Oct;11(7):651-64. [PubMed]
Fang M, Panguluri P, Machtinger EL, et al. Language, literacy, and characterization of stroke among patients taking warfarin for stroke prevention: implications for health communication. Patient Educ Couns. 2009 Jan 24. [Epub ahead of print] [PubMed]
Fang MC, Machtinger EL, Wang F, et al. Health literacy and anticoagulation-related outcomes among patients taking warfarin. J Gen Intern Med. 2006 Aug;21(8):841-6. [PubMed]
Machtinger E, Wang F, Chen L, et al. A visual medication schedule to improve anticoagulation control: a randomized, controlled trial. Jt Comm J Qual Patient Saf. 2007 Oct;33(10):625-35. [PubMed]
Schillinger D, Machtinger E, Wang F, et al. Preventing medication errors in ambulatory care: the importance of establishing regiment concordance. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US). 2005 Feb. AHRQ Publication No. 05-0021-1. [PubMed]
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Original publication: April 14, 2008.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: January 15, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: December 05, 2013.
Date verified by innovator indicates the most recent date the innovator provided feedback during the annual review process. The innovator is invited to review, update, and verify the profile annually.