Diabetes MellitusNCT01296633
Medtable: An Electronic Medical Record (EMR) Strategy to Promote Patient Medication Understanding and Use
A study testing Medtable in people with Diabetes Mellitus, run by University of Illinois at Urbana-Champaign at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Medtable
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medical Faculty Foundation Clinic of Northwestern University
Chicago, Illinois, 60611
OSF Medical Group of OSF Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Medtable
- Keywords
- health literacy, patient education, medication adherence, patient/provider communication, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedtableBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Medtable | Experimental | The Medtable is a patient education tool used for collaborative planning. The Medtable focuses patients on how to take their medication and prompts them to anchor this task to familiar routines. The tool serves as an external workspace that helps provider and patient jointly visualize how to integrate constraints from medications (e.g., which can be taken together; dose spacing) and patients' routine (e.g., typical meal times) in order to create an optimal daily schedule. The completed Medtable shows providers how patients are thinking about taking their medications, allowing them to clear up any confusion. It encourages teach-back and teach-to-goal strategies recommended for patients with low health literacy. Completing the Medtable helps patients implement as well as create plans by encouraging them to think about when and where they will actually take their medication. It also provides a template developed with their providers that could help patients load pill organizers at home. Receives: Behavioral: Medtable |
| Usual care | Active comparator | Patients in the usual care condition at both research sites will receive the medication counseling and communication that is standard of care at these sites. This includes a medication reconciliation process, where patients are given a card with list of medications that is periodically checked. This provides an opportunity for providers to correct patient knowledge of their medications, and is similar to the process of creating a list for the Medtable. However, the Medtable also encourages patients and providers to collaborate in order to organize this list in terms of the patient's routine to create a patient-specific, concrete plan for taking the medications. Receives: Behavioral: Medtable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication regimen knowledge
Measured: One year
Secondary outcomes (4)
Medication adherence
Measured: One year
Patient satisfaction with information about medications
Measured: One year
Glycosylated hemoglobin blood test (HBA1c)
Measured: One year
Patient-provider communication assessment
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, OSF Healthcare System
- Responsible party
- Principal investigator, Dan Morrow, University of Illinois at Urbana-Champaign
- Investigators
- Daniel G Morrow, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296633
- Sponsor's protocol ID
- 1R01NR011300-01A1
- Status last verified
- Aug 2016
- First submitted
- 6 Jan 2011
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Health literacy: report of the Council on Scientific Affairs. Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs, American Medical Association. JAMA. 1999 Feb 10;281(6):552-7.
PubMed 10022112Altman DE, Clancy C, Blendon RJ. Improving patient safety--five years after the IOM report. N Engl J Med. 2004 Nov 11;351(20):2041-3. doi: 10.1056/NEJMp048243. No abstract available.
PubMed 15537902American Diabetes Association. Standards of medical care in diabetes--2009. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S13-61. doi: 10.2337/dc09-S013. No abstract available.
PubMed 19118286Baker DW, Gazmararian JA, Sudano J, Patterson M. The association between age and health literacy among elderly persons. J Gerontol B Psychol Sci Soc Sci. 2000 Nov;55(6):S368-74. doi: 10.1093/geronb/55.6.s368.
PubMed 11078114Baker DW, Wolf MS, Feinglass J, Thompson JA, Gazmararian JA, Huang J. Health literacy and mortality among elderly persons. Arch Intern Med. 2007 Jul 23;167(14):1503-9. doi: 10.1001/archinte.167.14.1503.
PubMed 17646604Baker DW, Wolf MS, Feinglass J, Thompson JA. Health literacy, cognitive abilities, and mortality among elderly persons. J Gen Intern Med. 2008 Jun;23(6):723-6. doi: 10.1007/s11606-008-0566-4. Epub 2008 Mar 11.
PubMed 18330654Castro CM, Wilson C, Wang F, Schillinger D. Babel babble: physicians' use of unclarified medical jargon with patients. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1:S85-95. doi: 10.5555/ajhb.2007.31.supp.S85.
PubMed 17931142Davis TC, Wolf MS, Bass PF 3rd, Middlebrooks M, Kennen E, Baker DW, Bennett CL, Durazo-Arvizu R, Bocchini A, Savory S, Parker RM. Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med. 2006 Aug;21(8):847-51. doi: 10.1111/j.1525-1497.2006.00529.x.
PubMed 16881945Davis TC, Wolf MS, Bass PF 3rd, Thompson JA, Tilson HH, Neuberger M, Parker RM. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006 Dec 19;145(12):887-94. doi: 10.7326/0003-4819-145-12-200612190-00144. Epub 2006 Nov 29.
PubMed 17135578Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x.
PubMed 15610334DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, Sueta CA, Pignone MP. A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170]. BMC Health Serv Res. 2006 Mar 13;6:30. doi: 10.1186/1472-6963-6-30.
PubMed 16533388Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
PubMed 12558354Gazmararian JA, Baker DW, Williams MV, Parker RM, Scott TL, Green DC, Fehrenbach SN, Ren J, Koplan JP. Health literacy among Medicare enrollees in a managed care organization. JAMA. 1999 Feb 10;281(6):545-51. doi: 10.1001/jama.281.6.545.
PubMed 10022111Houts PS, Doak CC, Doak LG, Loscalzo MJ. The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient Educ Couns. 2006 May;61(2):173-90. doi: 10.1016/j.pec.2005.05.004. Epub 2005 Aug 24.
PubMed 16122896Kripalani S, Robertson R, Love-Ghaffari MH, Henderson LE, Praska J, Strawder A, Katz MG, Jacobson TA. Development of an illustrated medication schedule as a low-literacy patient education tool. Patient Educ Couns. 2007 Jun;66(3):368-77. doi: 10.1016/j.pec.2007.01.020. Epub 2007 Mar 6.
PubMed 17344015
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtable: An Electronic Medical Record (EMR) Strategy to Promote Patient Medication Understanding and Use
- ClinicalTrials.gov ID
- NCT01296633
- Acronym / sponsor ID
- 1R01NR011300-01A1
- Conditions
- Diabetes Mellitus
- Keywords
- health literacy, patient education, medication adherence, patient/provider communication, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Northwestern University, OSF Healthcare System
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medtable | Experimental | Behavioral: MedtableThe Medtable is a patient education tool used for collaborative planning. The Medtable focuses patients on how to take their medication and prompts them to anchor this task to familiar routines. The tool serves as an external workspace that helps provider and patient jointly visualize how to integrate constraints from medications (e.g., which can be taken together; dose spacing) and patients' routine (e.g., typical meal times) in order to create an optimal daily schedule. The completed Medtable shows providers how patients are thinking about taking their medications, allowing them to clear up any confusion. It encourages teach-back and teach-to-goal strategies recommended for patients with low health literacy. Completing the Medtable helps patients implement as well as create plans by encouraging them to think about when and where they will actually take their medication. It also provides a template developed with their providers that could help patients load pill organizers at home. |
| Usual care | Active comparator | Behavioral: MedtablePatients in the usual care condition at both research sites will receive the medication counseling and communication that is standard of care at these sites. This includes a medication reconciliation process, where patients are given a card with list of medications that is periodically checked. This provides an opportunity for providers to correct patient knowledge of their medications, and is similar to the process of creating a list for the Medtable. However, the Medtable also encourages patients and providers to collaborate in order to organize this list in terms of the patient's routine to create a patient-specific, concrete plan for taking the medications. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- Community-dwelling adults who are patients of participating providers and who meet the following inclusion criteria will participate:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedtableNurse 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. | Behavioural | Medtable, Usual care |
Primary outcome
Medication regimen knowledge
Time frame: One year
4 secondary outcomes
Medication adherence
Time frame: One year
Patient satisfaction with information about medications
Time frame: One year
Glycosylated hemoglobin blood test (HBA1c)
Time frame: One year
Patient-provider communication assessment
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Background: PubMed 10022112Health literacy: report of the Council on Scientific Affairs. Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs, American Medical Association. JAMA. 1999 Feb 10;281(6):552-7.
- Background: PubMed 15537902Altman DE, Clancy C, Blendon RJ. Improving patient safety--five years after the IOM report. N Engl J Med. 2004 Nov 11;351(20):2041-3. doi: 10.1056/NEJMp048243. No abstract available.
- Background: PubMed 19118286American Diabetes Association. Standards of medical care in diabetes--2009. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S13-61. doi: 10.2337/dc09-S013. No abstract available.
- Background: PubMed 11078114Baker DW, Gazmararian JA, Sudano J, Patterson M. The association between age and health literacy among elderly persons. J Gerontol B Psychol Sci Soc Sci. 2000 Nov;55(6):S368-74. doi: 10.1093/geronb/55.6.s368.
- Background: PubMed 17646604Baker DW, Wolf MS, Feinglass J, Thompson JA, Gazmararian JA, Huang J. Health literacy and mortality among elderly persons. Arch Intern Med. 2007 Jul 23;167(14):1503-9. doi: 10.1001/archinte.167.14.1503.
- Background: PubMed 18330654Baker DW, Wolf MS, Feinglass J, Thompson JA. Health literacy, cognitive abilities, and mortality among elderly persons. J Gen Intern Med. 2008 Jun;23(6):723-6. doi: 10.1007/s11606-008-0566-4. Epub 2008 Mar 11.
- Background: PubMed 17931142Castro CM, Wilson C, Wang F, Schillinger D. Babel babble: physicians' use of unclarified medical jargon with patients. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1:S85-95. doi: 10.5555/ajhb.2007.31.supp.S85.
- Background: PubMed 16881945Davis TC, Wolf MS, Bass PF 3rd, Middlebrooks M, Kennen E, Baker DW, Bennett CL, Durazo-Arvizu R, Bocchini A, Savory S, Parker RM. Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med. 2006 Aug;21(8):847-51. doi: 10.1111/j.1525-1497.2006.00529.x.
- Background: PubMed 17135578Davis TC, Wolf MS, Bass PF 3rd, Thompson JA, Tilson HH, Neuberger M, Parker RM. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006 Dec 19;145(12):887-94. doi: 10.7326/0003-4819-145-12-200612190-00144. Epub 2006 Nov 29.
- Background: PubMed 15610334Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x.
- Background: PubMed 16533388DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, Sueta CA, Pignone MP. A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170]. BMC Health Serv Res. 2006 Mar 13;6:30. doi: 10.1186/1472-6963-6-30.
- Background: PubMed 12558354Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel G Morrow, PhD principal investigator
University of Illinois at Urbana-Champaign
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtable in people with Diabetes Mellitus, run by University of Illinois at Urbana-Champaign at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication regimen knowledge (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296633, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.