NCT00256386

Brief Summary

Errors and preventable adverse events associated with medication prescription and dispensing are common, and the difference between guideline recommendations and the actual frequency of laboratory monitoring is substantial. This study evaluates three interventions to improve laboratory monitoring at initiation of medication therapy: an electronic medical record reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM), and a pharmacy team outreach (Pharmacy) compared to usual care (UC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

November 30, 2006

Status Verified

November 1, 2005

First QC Date

November 17, 2005

Last Update Submit

November 29, 2006

Conditions

Keywords

BaselineLaboratoryDrug

Outcome Measures

Primary Outcomes (3)

  • The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.

  • The study will evaluate the time to completion of the recommended labs.

  • The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.

Interventions

Eligibility Criteria

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

You may qualify if:

  • Dispensed one of 12 drugs or classes of drugs where baseline safety laboratory monitoring is recommended and labs have not been completed 6 months prior or 5 days after the dispense of the medication.
  • years of age or older
  • month HMO membership
  • drug benefit coverage
  • has telephone number

You may not qualify if:

  • recommended baseline laboratory monitoring completed
  • receives care and/or resides in hospice, nursing home, care outside HMO
  • enrolled in other care management program
  • nonEnglish speaking needing translation services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (44)

  • Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991 Feb 7;324(6):370-6. doi: 10.1056/NEJM199102073240604.

    PMID: 1987460BACKGROUND
  • Beard K. Adverse reactions as a cause of hospital admission in the aged. Drugs Aging. 1992 Jul-Aug;2(4):356-67. doi: 10.2165/00002512-199202040-00008.

    PMID: 1504448BACKGROUND
  • Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6.

    PMID: 9002492BACKGROUND
  • Burnum JF. Letter: Preventability of adverse drug reactions. Ann Intern Med. 1976 Jul;85(1):80-1. doi: 10.7326/0003-4819-85-1-80. No abstract available.

    PMID: 937927BACKGROUND
  • Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, Hebert L, Newhouse JP, Weiler PC, Hiatt H. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991 Feb 7;324(6):377-84. doi: 10.1056/NEJM199102073240605.

    PMID: 1824793BACKGROUND
  • Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995 Jul 5;274(1):29-34.

    PMID: 7791255BACKGROUND
  • Thomas EJ, Studdert DM, Burstin HR, Orav EJ, Zeena T, Williams EJ, Howard KM, Weiler PC, Brennan TA. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care. 2000 Mar;38(3):261-71. doi: 10.1097/00005650-200003000-00003.

    PMID: 10718351BACKGROUND
  • Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, Brennan TA, Bates DW. Drug complications in outpatients. J Gen Intern Med. 2000 Mar;15(3):149-54. doi: 10.1046/j.1525-1497.2000.04199.x.

    PMID: 10718894BACKGROUND
  • Hulse RK, Clark SJ, Jackson JC, Warner HR, Gardner RM. Computerized medication monitoring system. Am J Hosp Pharm. 1976 Oct;33(10):1061-4.

    PMID: 973633BACKGROUND
  • Lesar TS, Briceland L, Stein DS. Factors related to errors in medication prescribing. JAMA. 1997 Jan 22-29;277(4):312-7.

    PMID: 9002494BACKGROUND
  • Graham DJ, Drinkard CR, Shatin D, Tsong Y, Burgess MJ. Liver enzyme monitoring in patients treated with troglitazone. JAMA. 2001 Aug 15;286(7):831-3. doi: 10.1001/jama.286.7.831.

    PMID: 11497537BACKGROUND
  • Abookire SA, Karson AS, Fiskio J, Bates DW. Use and monitoring of

    BACKGROUND
  • Selby JV, Ettinger B, Swain BE, Brown JB. First 20 months' experience with use of metformin for type 2 diabetes in a large health maintenance organization. Diabetes Care. 1999 Jan;22(1):38-44. doi: 10.2337/diacare.22.1.38.

    PMID: 10333901BACKGROUND
  • Beach JE, Faich GA, Bormel FG, Sasinowski FJ. Black box warnings in prescription drug labeling: results of a survey of 206 drugs. Food Drug Law J. 1998;53(3):403-11. No abstract available.

    PMID: 10346718BACKGROUND
  • Raebel MA, Lyons EE, Andrade SE, Chan KA, Chester EA, Davis RL, Ellis JL, Feldstein A, Gunter MJ, Lafata JE, Long CL, Magid DJ, Selby JV, Simon SR, Platt R. Laboratory monitoring of drugs at initiation of therapy in ambulatory care. J Gen Intern Med. 2005 Dec;20(12):1120-6. doi: 10.1111/j.1525-1497.2005.0257.x.

    PMID: 16423101BACKGROUND
  • Shea S, DuMouchel W, Bahamonde L. A meta-analysis of 16 randomized controlled trials to evaluate computer-based clinical reminder systems for preventive care in the ambulatory setting. J Am Med Inform Assoc. 1996 Nov-Dec;3(6):399-409. doi: 10.1136/jamia.1996.97084513.

    PMID: 8930856BACKGROUND
  • Balas EA, Weingarten S, Garb CT, Blumenthal D, Boren SA, Brown GD. Improving preventive care by prompting physicians. Arch Intern Med. 2000 Feb 14;160(3):301-8. doi: 10.1001/archinte.160.3.301.

    PMID: 10668831BACKGROUND
  • Rind DM, Safran C, Phillips RS, Wang Q, Calkins DR, Delbanco TL, Bleich HL, Slack WV. Effect of computer-based alerts on the treatment and outcomes of hospitalized patients. Arch Intern Med. 1994 Jul 11;154(13):1511-7.

    PMID: 8018007BACKGROUND
  • Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. Arch Intern Med. 2003 Jun 23;163(12):1409-16. doi: 10.1001/archinte.163.12.1409.

    PMID: 12824090BACKGROUND
  • Hoch I, Heymann AD, Kurman I, Valinsky LJ, Chodick G, Shalev V. Countrywide computer alerts to community physicians improve potassium testing in patients receiving diuretics. J Am Med Inform Assoc. 2003 Nov-Dec;10(6):541-6. doi: 10.1197/jamia.M1353. Epub 2003 Aug 4.

    PMID: 12925546BACKGROUND
  • Freeborn DK PC. Promise and performance in managed care. Greenlick M, Freeborn D, Pope C, editors. 1994. Baltimore, MD, Johns Hopkins University Press.

    BACKGROUND
  • Feldstein AC, Smith DH, Robertson NR, Kovach CA, Soumerai SB, Simon SR, Sittig DF, Laferriere DS, Kalter M. Decision Support System Design and Implementation for Outpatient Prescribing: The Safety in Prescribing Study. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20567/

    PMID: 21250003BACKGROUND
  • Discount usability testing of computer-generated clinical alerts uncovers flaws. Denver, CO: 2003.

    BACKGROUND
  • Clark DO, Von Korff M, Saunders K, Baluch WM, Simon GE. A chronic disease score with empirically derived weights. Med Care. 1995 Aug;33(8):783-95. doi: 10.1097/00005650-199508000-00004.

    PMID: 7637401BACKGROUND
  • Hosmer DWJr, Lemeshow S. Applied survival analysis: Regression modeling of time to event data. New York: Wiley and Sons, 1999.

    BACKGROUND
  • Raudenbush S, Bryk A, Cheong YF, Congdon R. HLM 5 hierarchical linear and nonlinear modeling. Lincolnwood: Scientific Software International, 2001.

    BACKGROUND
  • Schiff GD, Klass D, Peterson J, Shah G, Bates DW. Linking laboratory and pharmacy: opportunities for reducing errors and improving care. Arch Intern Med. 2003 Apr 28;163(8):893-900. doi: 10.1001/archinte.163.8.893.

    PMID: 12719197BACKGROUND
  • Balas EA, Boren SA, Griffing G. Computerized management of diabetes: a synthesis of controlled trials. Proc AMIA Symp. 1998:295-9.

    PMID: 9929229BACKGROUND
  • Bates DW. Using information technology to reduce rates of medication errors in hospitals. BMJ. 2000 Mar 18;320(7237):788-91. doi: 10.1136/bmj.320.7237.788. No abstract available.

    PMID: 10720369BACKGROUND
  • Feldstein A, Elmer PJ, Smith DH, Herson M, Orwoll E, Chen C, Aickin M, Swain MC. Electronic medical record reminder improves osteoporosis management after a fracture: a randomized, controlled trial. J Am Geriatr Soc. 2006 Mar;54(3):450-7. doi: 10.1111/j.1532-5415.2005.00618.x.

    PMID: 16551312BACKGROUND
  • Skipwith DH. Telephone counseling interventions with caregivers of elders. J Psychosoc Nurs Ment Health Serv. 1994 Mar;32(3):7-12. doi: 10.3928/0279-3695-19940301-05.

    PMID: 8196022BACKGROUND
  • Poon EG, Gandhi TK, Sequist TD, Murff HJ, Karson AS, Bates DW.

    BACKGROUND
  • Smith CC, Bernstein LI, Davis RB, Rind DM, Shmerling RH. Screening for statin-related toxicity: the yield of transaminase and creatine kinase measurements in a primary care setting. Arch Intern Med. 2003 Mar 24;163(6):688-92. doi: 10.1001/archinte.163.6.688.

    PMID: 12639201BACKGROUND
  • Krishna S, Balas EA, Boren SA, Maglaveras N. Patient acceptance of educational voice messages: a review of controlled clinical studies. Methods Inf Med. 2002;41(5):360-9.

    PMID: 12501806BACKGROUND
  • Linkins RW, Dini EF, Watson G, Patriarca PA. A randomized trial of the effectiveness of computer-generated telephone messages in increasing immunization visits among preschool children. Arch Pediatr Adolesc Med. 1994 Sep;148(9):908-14. doi: 10.1001/archpedi.1994.02170090022002.

    PMID: 8075732BACKGROUND
  • Leirer VO, Morrow DG, Pariante G, Doksum T. Increasing influenza vaccination adherence through voice mail. J Am Geriatr Soc. 1989 Dec;37(12):1147-50. doi: 10.1111/j.1532-5415.1989.tb06679.x.

    PMID: 2592722BACKGROUND
  • Tanke ED, Leirer VO. Automated telephone reminders in tuberculosis care. Med Care. 1994 Apr;32(4):380-9. doi: 10.1097/00005650-199404000-00006.

    PMID: 8139302BACKGROUND
  • Friedman RH, Kazis LE, Jette A, Smith MB, Stollerman J, Torgerson J, Carey K. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. Am J Hypertens. 1996 Apr;9(4 Pt 1):285-92. doi: 10.1016/0895-7061(95)00353-3.

    PMID: 8722429BACKGROUND
  • Friedman RH, Stollerman J, Rozenblyum L, Belfer D, Selim A, Mahoney D, Steinbach S. A telecommunications system to manage patients with chronic disease. Stud Health Technol Inform. 1998;52 Pt 2:1330-4.

    PMID: 10384677BACKGROUND
  • Piette JD, Mah CA. The feasibility of automated voice messaging as an adjunct to diabetes outpatient care. Diabetes Care. 1997 Jan;20(1):15-21. doi: 10.2337/diacare.20.1.15.

    PMID: 9028687BACKGROUND
  • Delichatsios HK, Friedman RH, Glanz K, Tennstedt S, Smigelski C, Pinto BM, Kelley H, Gillman MW. Randomized trial of a "talking computer" to improve adults' eating habits. Am J Health Promot. 2001 Mar-Apr;15(4):215-24. doi: 10.4278/0890-1171-15.4.215.

    PMID: 11349340BACKGROUND
  • Raebel MA, Lyons EE, Chester EA, Bodily MA, Kelleher JA, Long CL, Miller C, Magid DJ. Improving laboratory monitoring at initiation of drug therapy in ambulatory care: a randomized trial. Arch Intern Med. 2005 Nov 14;165(20):2395-401. doi: 10.1001/archinte.165.20.2395.

    PMID: 16287769BACKGROUND
  • Simon SR, Andrade SE, Ellis JL, Nelson WW, Gurwitz JH, Lafata JE, Davis RL, Feldstein A, Raebel MA. Baseline laboratory monitoring of cardiovascular medications in elderly health maintenance organization enrollees. J Am Geriatr Soc. 2005 Dec;53(12):2165-9. doi: 10.1111/j.1532-5415.2005.00498.x.

    PMID: 16398903BACKGROUND
  • Feldstein AC, Smith DH, Perrin N, Yang X, Rix M, Raebel MA, Magid DJ, Simon SR, Soumerai SB. Improved therapeutic monitoring with several interventions: a randomized trial. Arch Intern Med. 2006 Sep 25;166(17):1848-54. doi: 10.1001/archinte.166.17.1848.

MeSH Terms

Interventions

Electronic Health RecordsRadiotherapy

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTherapeutics

Study Officials

  • Adrianne C. Feldstein, MD, MS

    Northwest Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

January 1, 2004

Study Completion

March 1, 2005

Last Updated

November 30, 2006

Record last verified: 2005-11

Locations