Medtable: An Electronic Medical Record (EMR) Strategy to Promote Patient Medication Understanding and Use

Diabetes Mellitus Clinical Trial

Official title:

Medtable: An Electronic Medical Record (EMR) Strategy to Promote Patient Medication Understanding and Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296633
• Other study ID #: 1R01NR011300-01A1
• Status: Completed
• Phase: N/A
• First received: January 6, 2011
• Last updated: August 7, 2016
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Medtable
Nurse works with patient to reconcile EMR-based medication list and load list into Medtable. Nurse uses Medtable with patient to develop plans for taking medications. Patient completes Medtable columns to identify when routine activities are performed during the day. Nurse discusses medications with patient: what the medication is called, used for, etc. Nurse and patient jointly develop the schedule by choosing times to take each medication. These times are entered into corresponding cells of the Medtable. Nurse corrects any mistakes (e.g., times that would conflict with dose spacing requirements). Nurse asks patient to review to ensure patient understands key facts and that drug interactions or other restrictions are addressed, using collaborative inquiry, teach-back, and teach-to-goal strategies. Patient takes home a hardcopy of the Medtable schedule to guide adherence. An updated e-copy is integrated with patient's record in the EMR.

Locations

Country	Name	City	State
United States	Northwestern Medical Faculty Foundation Clinic of Northwestern University	Chicago	Illinois
United States	OSF Medical Group of OSF Saint Francis Medical Center	Peoria	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Northwestern University, OSF Healthcare System

Country where clinical trial is conducted

United States, 

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication regimen knowledge		One year	No
Secondary	Medication adherence		One year	No
Secondary	Patient satisfaction with information about medications		One year	No
Secondary	Glycosylated hemoglobin blood test (HBA1c)		One year	No
Secondary	Patient-provider communication assessment		One day	No