Comparative Effectiveness of Patient-centered Strategies to Improve FDA Medication Guides

Wolf, Michael S.; Bailey, Stacy Cooper; Serper, Marina; Smith, Meredith Y.; Davis, Terry C.; Russell, Allison L.; Manzoor, Beenish S; Belter, Lisa; Parker, Ruth M.; Lambert, Bruce L.

doi:10.1097/mlr.0000000000000182

Cited by 39 publications

(28 citation statements)

References 22 publications

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“…Specifically, the EHR has been programmed to print low-literacy medication information summaries and a medication list along with the After Visit Summary. Both were developed by our research team and a previous study among 1003 patients found that the summaries significantly improved patients’ ability to retrieve and apply medication information [12]. These tools now serve as standard of care for Erie Family Health clinics providing primary care for adult patients.…”

Section: Methodsmentioning

confidence: 99%

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults

Bailey

Wismer

Parker

et al. 2017

Contemporary Clinical Trials

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BACKGROUND Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation. OBJECTIVE To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults. METHODS Older, English or Spanish-speaking patients on complex drug regimens (N=1,505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2 months, and 6 months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated. CONCLUSIONS This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations.

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Section: Methodsmentioning

confidence: 99%

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults

Bailey

Wismer

Parker

et al. 2017

Contemporary Clinical Trials

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“…Studies looking at the use of the MedSheet and similar medication guides show an improvement in patient knowledge that ranges from 7% to 24%, using composite scores. 27 We did not calculate a composite knowledge score, but for individual items our improvement was in a similar range (19.8% improvement on knowledge about taking acetaminophen largest improvement).…”

Section: Discussionmentioning

confidence: 99%

“…In addition to properly sequenced content and improved readability, the MedSheets format has resulted in higher recall of drug information than the current FDA standard or sheets containing the same text with different layout. 27 Among the medication information sheets created, 10 were specific to opioids and the sheet for hydrocodoneacetaminophen was used in this study. These sheets initially were designed for use in an internal medicine clinic setting; we modified them minimally for the ED setting (e.g., altered specifics regarding information about seeking refills).…”

Section: Study Protocolmentioning

confidence: 99%

Improving Patient Knowledge and Safe Use of Opioids: A Randomized Controlled Trial

McCarthy

Wolf

McConnell

et al. 2015

Academic Emergency Medicine

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Objectives: The use of opioid analgesics in the United States has significantly increased in recent years. However, there is minimal consensus on what discharge counseling should accompany these high-risk prescriptions and large variations in what is done in practice. The objective of this study was to evaluate the effect of a dual-modality (written and spoken) literacy-appropriate educational strategy on patients' knowledge of and safe use of opioid analgesics.Methods: This was a prospective, randomized controlled trial. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new prescriptions for hydrocodone-acetaminophen were enrolled. Patients were randomized to receive either usual care or the educational intervention. The educational intervention was a one-page information sheet about hydrocodone-acetaminophen, which was both given to the patients and read aloud by the research assistant (nonblinded). Follow-up phone calls were conducted 4 to 7 days after the visit to assess patient knowledge about the medication and self-report of activities associated with safety of use (e.g., double-dipping with acetaminophen, storage, use with alcohol or while driving).Results: A total of 274 patients were enrolled; 210 completed follow-up (110 usual care and 100 intervention). No significant differences in baseline characteristics emerged between the study arms; 42% were male, and 51% were white, with a median age of 43 years. Half of patients had non-back pain orthopedic injuries (49.5%). On follow-up, overall knowledge was poor, with only 28% able to name both active ingredients in the medication. The intervention group had better knowledge of precautions related to taking additional acetaminophen (usual care 18.2%, 95% confidence interval [CI] = 10.9% to 25.5% vs. intervention 38%, 95% CI = 28.3% to 47.7%; difference = 27.6, 95% CI of difference = 21.5 to 33.7) and knowledge of side effects (usual care median = 1, interquartile range [IQR] 0 to 2 vs. intervention median = 2, IQR = 1 to 2; p < 0.0001). Additionally, those who received the intervention were less likely to have reported driving within 6 hours after taking hydrocodone (usual care 13.6%, 95% CI = 7.2% to 20% vs. intervention 3%, 95% CI = -0.3% to 6.3%; difference = 10.6, 95% CI of difference = 3.4 to 17.9). There was no difference between groups related to knowledge about drinking alcohol while taking hydrocodone (overall 18.1%) or knowledge that the opioid could be addictive (overall 72.4%).Conclusions: This simple strategy improved several, but not all, aspects of patient knowledge and resulted in fewer patients in the intervention arm driving while taking hydrocodone. Integration of a patient education document into conversations about opioids holds promise for improving patient knowledge about these high-risk medications.ACADEMIC EMERGENCY MEDICINE 2015;22:331-339

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“…Discharge education for patients presenting to the ED with complaints as diverse as acute anaphylaxis, hypoglycemia, and minor head injury has been found to be lacking [17][18][19][20]. Strategies to improve accessibility of patient-directed written information may improve patient comprehension and ultimately contribute to the realization of improved outcomes, including medication compliance [21,22]. Thus, research defining optimal discharge instructional delivery is needed.…”

Section: Introductionmentioning

confidence: 99%

Seventy-two-hour antibiotic retrieval from the ED: a randomized controlled trial of discharge instructional modality

Olives

Patel

Thompson

et al. 2016

The American Journal of Emergency Medicine

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Comparative Effectiveness of Patient-centered Strategies to Improve FDA Medication Guides

Abstract: Clinical Trials.Gov #NCT01731405.

Cited by 39 publications

References 22 publications

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults

Improving Patient Knowledge and Safe Use of Opioids: A Randomized Controlled Trial

Seventy-two-hour antibiotic retrieval from the ED: a randomized controlled trial of discharge instructional modality

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