NCT01787175

Brief Summary

The purpose of this study is to advance the science of healthcare informatics and to improve medication management through the development of a new approach to the electronic medical record called the Integrated Medication Manager (IMM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

June 23, 2016

Completed
Last Updated

June 23, 2016

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

January 22, 2013

Results QC Date

January 3, 2014

Last Update Submit

May 17, 2016

Conditions

Electronic Health Records

Keywords

Medication Therapy ManagementClinical Decision Support SystemsMedical InformaticsPatient Care ManagementUnited States Department of Veterans Affairs

Outcome Measures

Primary Outcomes (2)

  • Amount of Time to Complete Assessment and Plan

    Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.

    10 minutes

  • Accuracy of Written Assessment and Plan in Terms of Control and Status

    Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. The primary outcome evaluated participants' recommendations for treatment of patient conditions. Participants reviewed a total of 10 patient cases and received a score between 0 and 3 points for each issue within each patient case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent greater accuracy of the written assessment and plan.

    10 minutes

Secondary Outcomes (1)

  • Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan

    10 minutes

Study Arms (2)

Integrated Medication Manager

EXPERIMENTAL

Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.

Other: Integrated Medication Manager

Standard EHR

NO INTERVENTION

Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.

Interventions

Integrated Medication ManagerOTHER

A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use.

Also known as: IMM
Integrated Medication Manager

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Practiced in primary care for at least two years
  • Third year residents with two years of residency in internal medicine or family practice
  • Do not have to be currently practicing

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA SLC Health Care System

Salt Lake City, Utah, 84148, United States

Location

Related Publications (19)

  • Asch SM, McGlynn EA, Hogan MM, Hayward RA, Shekelle P, Rubenstein L, Keesey J, Adams J, Kerr EA. Comparison of quality of care for patients in the Veterans Health Administration and patients in a national sample. Ann Intern Med. 2004 Dec 21;141(12):938-45. doi: 10.7326/0003-4819-141-12-200412210-00010.

    PMID: 15611491BACKGROUND

  • Perlin JB, Pogach LM. Improving the outcomes of metabolic conditions: managing momentum to overcome clinical inertia. Ann Intern Med. 2006 Apr 4;144(7):525-7. doi: 10.7326/0003-4819-144-7-200604040-00012. No abstract available.

    PMID: 16585667BACKGROUND

  • Morris AH. Developing and implementing computerized protocols for standardization of clinical decisions. Ann Intern Med. 2000 Mar 7;132(5):373-83. doi: 10.7326/0003-4819-132-5-200003070-00007.

    PMID: 10691588BACKGROUND

  • Fox J, Alabassi A, Black E, Hurt C, Rose T. Modelling clinical goals: a corpus of examples and a tentative ontology. Stud Health Technol Inform. 2004;101:31-45.

    PMID: 15537204BACKGROUND

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    PMID: 8976626BACKGROUND

  • Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001 Nov 6;135(9):825-34. doi: 10.7326/0003-4819-135-9-200111060-00012.

    PMID: 11694107BACKGROUND

  • Nebeker JR, Hurdle JF, Bair BD. Future history: medical informatics in geriatrics. J Gerontol A Biol Sci Med Sci. 2003 Sep;58(9):M820-5. doi: 10.1093/gerona/58.9.m820.

    PMID: 14528038BACKGROUND

  • Crosson JC, Stroebel C, Scott JG, Stello B, Crabtree BF. Implementing an electronic medical record in a family medicine practice: communication, decision making, and conflict. Ann Fam Med. 2005 Jul-Aug;3(4):307-11. doi: 10.1370/afm.326.

    PMID: 16046562BACKGROUND

  • Hayward RA, Asch SM, Hogan MM, Hofer TP, Kerr EA. Sins of omission: getting too little medical care may be the greatest threat to patient safety. J Gen Intern Med. 2005 Aug;20(8):686-91. doi: 10.1111/j.1525-1497.2005.0152.x.

    PMID: 16050875BACKGROUND

  • Tinetti ME, Bogardus ST Jr, Agostini JV. Potential pitfalls of disease-specific guidelines for patients with multiple conditions. N Engl J Med. 2004 Dec 30;351(27):2870-4. doi: 10.1056/NEJMsb042458. No abstract available.

    PMID: 15625341BACKGROUND

  • Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.

    PMID: 15755945BACKGROUND

  • Shekelle PG. Invited commentary: Implementation of health information technology: an important but challenging field of inquiry. Proc (Bayl Univ Med Cent). 2006 Oct;19(4):313. doi: 10.1080/08998280.2006.11928190. No abstract available.

    PMID: 17106490BACKGROUND

  • Weir CR, Nebeker JJ, Hicken BL, Campo R, Drews F, Lebar B. A cognitive task analysis of information management strategies in a computerized provider order entry environment. J Am Med Inform Assoc. 2007 Jan-Feb;14(1):65-75. doi: 10.1197/jamia.M2231. Epub 2006 Oct 26.

    PMID: 17068345BACKGROUND

  • Berg CA, Strough JN, Calderone KS, Sansone C, Weir C. The role of problem definitions in understanding age and context effects on strategies for solving everyday problems. Psychol Aging. 1998 Mar;13(1):29-44. doi: 10.1037//0882-7974.13.1.29.

    PMID: 9533188BACKGROUND

  • Weir CR. Linking information needs with evaluation: the role of task identification. Proc AMIA Symp. 1998:310-4.

    PMID: 9929232BACKGROUND

  • Taatz H. [The problem of the time factor in orthodontic treatment]. Stomatol DDR. 1976 Feb;26(2):102-5. No abstract available. German.

    PMID: 1065968BACKGROUND

  • Campbell M, Grimshaw J, Steen N. Sample size calculations for cluster randomised trials. Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action). J Health Serv Res Policy. 2000 Jan;5(1):12-6. doi: 10.1177/135581960000500105.

    PMID: 10787581BACKGROUND

  • Miller RH, Sim I. Physicians' use of electronic medical records: barriers and solutions. Health Aff (Millwood). 2004 Mar-Apr;23(2):116-26. doi: 10.1377/hlthaff.23.2.116.

    PMID: 15046136BACKGROUND

  • Bradley EH, Bogardus ST Jr, Tinetti ME, Inouye SK. Goal-setting in clinical medicine. Soc Sci Med. 1999 Jul;49(2):267-78. doi: 10.1016/s0277-9536(99)00107-0.

    PMID: 10414834BACKGROUND

Limitations and Caveats

We were not able to evaluate a system-wide deployment of the resulting graphical user interface (GUI) (IMM) in terms of patient outcomes (Aim 3). We were unable to conduct Aim 3, which would have evaluated IMM in a cluster-randomized trial.

Results Point of Contact

Title
Dr. Jonathan Nebeker
Organization
University of Utah Health Care System
Jonathan.Nebeker@hsc.utah.edu
801-582-1565

Study Officials

  • Jonathan Nebeker, MD, MS

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

February 8, 2013

Study Start

October 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 23, 2016

Results First Posted

June 23, 2016

Record last verified: 2016-05

Locations

US(1)