An EMR-based tool to support collaborative planning for medication use among adults with diabetes: Design of a multi-site randomized control trial☆
Introduction
Type II diabetes is a prevalent chronic illness in the US that tends to increase with age [1]. Along with managing blood glucose levels, medication is central to treating and managing diabetes in ambulatory care. Nonadherence is a common barrier to effective treatment—as many as half of patients do not take their medications as prescribed [2], [3]. The problem is linked to many patient, medication-, and system-related factors [4]. One important reason for nonadherence involves a gap between the demands of adherence and the limited resources that patients bring to this complex task. This gap is exacerbated by inadequate support from the health care system. Adherence demands depend on factors such as medication regimen complexity. Complex regimens require patients to create plans for taking multiple medications that meet many constraints, such as medication interactions and auxiliary instructions. Nonadherence increases with complexity [5], in part because of inadequate planning [6]. Planning requires health literacy skills [6], [7], [8] and broader cognitive resources such as processing capacity (e.g., working memory) and health knowledge [9]. Adherence especially challenges older adults, who are more likely to have a chronic illness requiring complex regimens, yet experience declines in literacy and cognitive resources needed for self-care [4], [5].
Patient–provider collaboration and other system support are crucial for adherence [10], [11]. For example, patient education can increase knowledge and literacy skills, and simplifying regimens and coordinating treatment across providers reduces demands on adherence. Unfortunately, system support is often inadequate, especially for adults with lower health literacy [2]. Collaboration requires partners to work together to ensure information is mutually understood [12]. However, providers do not always collaborate with patients effectively. For example, they may not present key information [13], use patient-centered language [14], or check patients’ comprehension of information [15], [16]. More generally, system support for medication management in primary care is inadequate for supporting adequate adherence. Medication review is sporadic and fragmented [17] and reconciliation, the process of ensuring comprehensive and current patient medication lists, is lacking [2].
The consequences of inadequate system support are especially acute for adults with low health literacy because, although they may be most likely to benefit from it, they are also less likely to develop shared adherence plans with their providers, leading to nonadherence [2], [18], [19]. Adults with diabetes and lower health literacy report worse communication with providers [20] and have worse health outcomes than do patients with adequate literacy [21], [22].
Poor patient–provider collaboration reflects system barriers such as limited patient contact time, inadequate communication training, and lack of support for consistent use of patient-centered strategies [2]. Health information technology (IT) can provide system support for patient-centered communication [23], [24]. For example, comprehensive medication lists printed on cards are recommended for medication review and reconciliation with patients, but studies evaluating such cards in pharmacy [25], hospital discharge [26], and specialized clinic [18] environments produce inconsistent evidence. This may reflect the fact that the cards were not designed to support patient–provider collaboration nor linked with health IT and thus not integrated with clinical practice. There is a need for robust support for collaborative medication management [2]. This paper details the development of a tool to support the patient/provider collaboration that is important to medication use among older adults with diabetes, and describes a study that will evaluate the impact of the tool on patient outcomes.
Section snippets
Study overview
We are evaluating the effects of an IT-based intervention designed to improve patient–provider collaboration in primary care clinics on medication use and health-related outcomes among patients with type II diabetes. The intervention involves nurses using the interactive, EMR-integrated tool (the Medtable™) to support patients’ medication planning. Nurses were chosen to deliver the intervention because their education and training focuses on patient-centered care, they indicate a need for
Design
The study is a multi-site longitudinal randomized controlled trial, and is registered on clinicaltrials.gov. A simple 1:1 random assignment is made at each site, placing patients in either the Medtable™ intervention study arm (see Section III) or to a usual care condition. Patients in the usual care condition at both research sites receive the medication counseling and communication that is standard of care at these sites. This includes a medication reconciliation process supported by patient
Procedure
For their first study appointment, patients schedule a time to come in within a week after their next regularly scheduled appointment. A research assistant administers the baseline individual differences battery, the medication knowledge, and adherence measures (about 45 min). Then patients in the intervention condition work with intervention nurses using the Medtable™. Immediately following the intervention with the nurse, patients meet with a research assistant during which medication
Planned analyses
The primary analyses evaluate whether the Medtable™ intervention improves patient outcomes relative to the usual care group by using multivariable generalized linear models that include patient education, medication regimen complexity, patient health status (time since diabetes diagnosis, number of co-morbid conditions), self-reported frequency of diabetes self-care activities, and provider experience as co-variates. Group (Intervention vs. Control), Time and Group × Time interaction terms, will
Discussion
Patients with type II diabetes often struggle with self-care, especially the ability to take complex medication regimens as prescribed. Medication nonadherence in this population relates to many factors, including a gap between the demands of taking medication, limited literacy, and cognitive resources that patients bring to this task, which is exacerbated by inadequate patient–provider collaboration and other aspects of the health care system. The Medtable™ intervention is designed to support
Acknowledgments
This material is based upon work supported by the National Institutes of Health grant # 1R01NR01130. Any opinions, findings, and conclusions or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the NIH. We thank Sameem Samad and Imadhulah Syed for Medtable development and support.
References (70)
- et al.
A visual medication schedule to improve anticoagulant care: a randomized controlled trial
Jt Comm J Qual Patient Saf
(2007) - et al.
Development of an illustrated medication schedule as a low‐literacy patient education tool
Patient Educ Couns
(2007) - et al.
A lowliteracy medication education tool for safety-net hospital patients
Am J Prev Med
(2009) - et al.
Distributed cognition: an alternative model of cognition for medical informatics
Int J Med Inform
(2008) How a cockpit remembers its speeds
Cogn Sci
(1995)- et al.
The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence
Patient Educ Couns
(2006) - et al.
Why a diagram is (sometimes) worth ten thousand words
Cogn Sci
(1987) Alternative representations
- et al.
Health literacy and knowledge of chronic illness
Patient Educ Couns
(2003) - et al.
A new method of classifying prognostic comorbidity in longitudinal studies: development and validation
J Chronic Dis
(1987)
Literacy, self-efficacy, and HIV medication adherence
Patient Educ Couns
Standards of medical care in diabetes
Diabetes Care
Preventing medication errors
Adherence to medication
N Engl J Med
Medication adherence among older adults: a systems perspective
Medication adherence and aging
Helping patients simplify and safely use complex medication regimens
Arch Intern Med
A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial
BMC Health Serv Res
Literacy and learning in health care
Pediatrics
The process-knowledge model of health literacy: evidence from a componential analysis of two commonly used measures
J Health Commun
Patient self-management of chronic illness in primary care
JAMA
Finding common ground: patient-centeredness and evidence-based chronic illness care
J Altern Complement Med
Using language
Physician communication when prescribing new medications
Arch Intern Med
Effective physician–patient communication and health outcomes: a review
J Can Med Assoc
Closing the loop: physician communication with diabetic patients who have low health literacy
Arch Intern Med
Communication techniques for patients with low health literacy: a survey of physicians, nurses, and pharmacists
Am J Health Behav
How do physicians conduct medication reviews?
J Gen Intern Med
Limited health literacy is a barrier to medication reconciliation in ambulatory care
J Gen Intern Med
The importance of establishing regimen concordance in preventing medication errors in anticoagulant care
J Health Commun
When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make?
J Gen Intern Med
Association of health literacy with diabetes outcomes
JAMA
How health care systems can begin to address the challenge of limited literacy
J Gen Intern Med
Preparing for an epidemic of limited health literacy: weathering the perfect storm
J Gen Intern Med
Transforming nurses' work environments to improve patient safety: The Institute of Medicine Recommendations
Policy Polit Nurs Pract
Cited by (19)
Design of human centered augmented reality for managing chronic health conditions
2018, Aging, Technology and HealthA review of randomized controlled trials of medical record powered clinical decision support system to improve quality of diabetes care
2016, International Journal of Medical InformaticsCitation Excerpt :Meigs et al. report decreased levels of glycated hemoglobin by 0.2 in comparison to control group where level was increased by 0.1 (p = 0.09). The study by Morrow et al. [14], on the contrary, did not detect any improvement in level of HbA1c at four quarterly follow up in study period of one year. Sequist et al. [25] report that electronic reminders for overdue annual LDL cholesterol testing result in increased screening rates (Hazard ration 1.41, 95%CI; 1.15–1.72), although O’Connor et al. [19] report little to no intervention effects in the measure of LDL cholesterol test rate during study period.
The antecedents, forms and consequences of patient involvement: A narrative review of the literature
2016, International Journal of Nursing StudiesTechnology-Based Support for Older Adult Communication in Safety-Critical Domains
2016, Psychology of Learning and Motivation - Advances in Research and TheoryCitation Excerpt :At the end of the visit, the patient took a printed copy of the schedule home to use as a guide to adherence. A randomized trial was conducted to evaluate the impact of the MedTable-based intervention relative to a usual care control group on diabetic patients' knowledge about their medications, self-reported medication adherence, satisfaction with provider communication about medications, and HbA1c levels (Morrow et al., 2012). Data collection is complete and currently being analyzed.
May I Have Another?-Medication Error
2015, AORN Journal