Clinical trial NCT01296633: Medtable: An Electronic Medical Record (EMR) Strategy to Promote Patient Medication Understanding and Use
Official title: Medtable: An Electronic Medical Record (EMR) Strategy to Promote Patient Medication Understanding and Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: health literacy
patient education
medication adherence
patient/provider communication
Diabetes Mellitus
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: OSF Healthcare System
First posted: 2011-02-15
Enrollment: 674
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The broad goal of this project is to improve knowledge of and adherence to medication regimens and health outcomes among adults with type 2 diabetes or other metabolic disorders. These patients have complex self-care needs, but limited literacy and cognitive skills to meet these needs. Medication error is widespread and costly, and often associated with inadequate patient knowledge about medication, especially among chronically ill adults with limited health literacy. Inadequate knowledge is often traced to limited communication with providers, in part because of barriers such as limited patient contact time and communication training, and lack of system-level support for consistent use of patient-centered strategies. There is a need to leverage information technology (IT) to provide system-based support for patient-centered communication. The investigators will evaluate an Electronic Medical Record (EMR)-based tool (the Medtable) to support provider/patient communication and improve medication knowledge, adherence, and health outcomes among chronically ill adults with complex medication regimens. A paper-based Medtable has been found to help older adults create accurate medication schedules in a simulated patient/provider communication task (Morrow et al., 2008). Benefits for patients should be enhanced if the Medtable is integrated with an EMR, giving providers ready access to relevant background information and current medication lists that patients can update, so providers can generate and tailor the Medtable for a diverse set of patients. This system provides an integrated approach to patient education about medications, from prescribing to counseling during office visits. As a result, patients would not only understand how to take their medications, but develop concrete plans for doing so. Specific aims of the project are: 1) Refine the Medtable prototype for use in an EMR environment. This includes developing protocols for generating patient-specific Medtables and educating providers to use them in medical encounters. 2) Evaluate the Medtable's impact on patient care processes and outcomes. The investigators will test the following hypothesis about communication processes: H1) Patients in the intervention condition will be more satisfied with communication about medication than patients in the usual care condition. The investigators will also test the following hypotheses about patient outcomes: Compared to usual care patients, patients receiving the Medtable intervention will: H2) know more about their medications; H3) adhere more accurately to their medication regimens; H4) more likely have blood glucose (glycosylated hemoglobin, HbA1c) levels in the target range. Aim 1 will be accomplished by interviewing physicians and their patients as the system is refined to ensure ease of using the system, and by collecting preliminary evidence that the Medtable improves patient/provider communication. After establishing initial feasibility and ensuring provider acceptance of the system, Aim 2 is addressed by a randomized trial at the general internal medicine clinics in Chicago and Peoria (IL), comparing patients who use the Medtable with their providers to those receiving usual care.

Detailed description: The investigators will integrate the paper-based Medtable into the electronic medical record (EMR) system at the two research sites and evaluate whether this EMR-based tool improves patient/provider communication, patients' medication knowledge, and health outcomes. The EMR will produce Medtables that summarize patients' complex medication schedules with simple, direct language. The Medtable will be used interactively by providers and patients with complex self-care needs in order to create patient-specific adherence plans. Thus, the EMR-based Medtable will help integrate patient-centered communication practices into the prescribing and counseling phases of the medication use process. The Medtable will be used by nurses as part of medication reconciliation and counseling at general internal medicine clinics in Chicago and Peoria that provide routine care to outpatients with complex health care needs. The researchers seek to investigate adults who take complex medication regimens to treat their chronic illness and struggle with self-care (patients with diabetes or other metabolic disorders who have glycosylated hemoglobin (HbA1c) levels higher than 7.0). Patients varying in age, education, and literacy/cognitive abilities will be recruited in order to explore whether the Medtable especially benefits those with lower health literacy, reducing literacy-related differences in medication knowledge, adherence, and outcomes.

In Phase I, the investigators develop the EMR-based Medtable (Year 1). To collect initial feasibility data, the Medtable will be integrated into the EMR-supported practice of several physicians at general internal medicine clinics serving diverse patient populations at Northwestern Medical Foundation (Chicago) and OSF Medical Group (Peoria). Both sites use the Epic EMR system (Epic Systems Corp, Verona, WI). Through interviews and questionnaires the researchers will assess ease of using the Medtable as part of routine clinical practice. Preliminary data about physician adoption (e.g., frequency of generating Medtables for patients) will be collected. Patients of these physicians will be interviewed about ease of using the Medtable and whether it improves satisfaction with patient/provider communication, knowledge, and ability to take their medications. Medtable interface and protocol will be iteratively refined in response to provider and patient feedback.

In Phase II, the researchers will use a randomized trial to evaluate the efficacy of the EMR-based Medtable as a provider/patient collaboration tool for improving patient knowledge and outcomes (Years 2-3).

The researchers will use a random process to assign patients at each clinic site to the Medtable intervention or to usual care condition. For the intervention, the Medtable will be integrated into routine patient activities during office visits: a) during intake, intervention nurses generate the Medtable via the EMR and reconcile medication lists by working with patients; b) at the end of the visit, the nurses and patients use the Medtable to develop easy to understand and implement patient-specific plans for taking the medications. Patients take home a hardcopy of their Medtable-based schedule to guide adherence, and the electronic copy is integrated with the patient EMR.

Outcome measures (for both intervention and usual care patients) are medication knowledge (immediately, 3, and 6 months after the Medtable intervention is introduced), adherence (baseline, 3 and 6 months), and HbA1c level (baseline, 3, 6, 9 and 12 months). Finally, data about how the Medtable is used will be collected, including frequency of generating the Medtable during patient visits, and time required to generate and use the Medtable during routine office visits.

Eligibility criteria: Providers:

Physicians will be eligible if they have a significant proportion of patients age 40 or older with metabolic disorders.

Inclusion criteria for nurses will be:

* a current RN, LPN certificate or BSN degree
* practicing at least 10 hours weekly
* providing primary care to adults over age 40 years with chronic illness

This should ensure that we recruit physicians and nurses who teach patients about medication as part of their routine responsibilities.

Patient Participants:

Community-dwelling adults who are patients of participating providers and who meet the following inclusion criteria will participate:

* age 40 and older
* native speaker of English or English speaker before age of 6
* no physical or cognitive impairments that could limit participation (e.g., stroke in the last 3 years, current cancer treatment involving radiation or chemotherapy)
* score of 24 or higher on the Mini Mental State Exam (Folstein, Folstein, \& McHugh, 1975)
* no severe visual impairment (\<20/50 corrected vision) or auditory impairment that would limit participation
* diagnosis of type 2 diabetes or other metabolic disorders (they are also likely to have other chronic illnesses such as hypertension)
* taking at least 5 prescribed medications
* HbA1c level of 7.0 or higher

Primary outcomes:
measure: Medication regimen knowledge
timeFrame: One year
Secondary outcomes:
measure: Medication adherence
timeFrame: One year
measure: Patient satisfaction with information about medications
timeFrame: One year
measure: Glycosylated hemoglobin blood test (HBA1c)
timeFrame: One year
measure: Patient-provider communication assessment
timeFrame: One day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation Clinic of Northwestern University
state: Illinois
city: Peoria
country: United States
facility: OSF Medical Group of OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Daniel G Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
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