SafetyNCT00256386
LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Laboratory Monitoring
A study testing Electronic Medical Record (EMR) to clinician's in-basket, Automated Voice Message (AVM) reminder to patient's phone and Pharmacy Team phone call-letter followup in people with Safety, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety
- What is being tested?
- Electronic Medical Record (EMR) to clinician's in-basket, Automated Voice Message (AVM) reminder to patient's phone and Pharmacy Team phone call-letter followup
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Mar 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 years of age or older
- 12-month HMO membership
- drug benefit coverage
- has telephone number
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
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).
Read the detailed description
Many of the medications that clinicians prescribe to prevent or treat disease can result in unanticipated and unintended toxic effects. Many national clinical guidelines recommend baseline and periodic laboratory monitoring to avoid adverse drug events. Our Safety in Prescribing project (SIP) has found many significant gaps in medication safety. Lab Alert will evaluate electronic tools to improve Kaiser Permanente's performance in laboratory monitoring to avoid adverse drug events. We will enroll patients who are taking high-risk medications and who have not received laboratory monitoring. The primary outcome of this 2-year study is the proportion of patients who receive guideline-based laboratory monitoring at 1 and 3 weeks post-intervention.
Fifteen primary care clinics will be randomly assigned to: (1) usual care (UC) (2) electronic message reminder (EMR) (3) automated voice message (AVM) (4) pharmacy outreach team (Pharmacy). The reminders will notify of the patient's need for guideline-specified laboratory testing due to medication use. Using electronic data, patients with PCPs assigned to intervention clinics who are on study-specified medications will be identified and screened for exclusions, to yield 600 patients (200 per intervention group). Patients will be assigned to the treatment groups on the basis of the condition assigned to their usual clinic. After the intervention and observation periods, and using the same time frame and inclusion and exclusion criteria used to identify the patients in the intervention arms, we will retrospectively identify a comparison 200-patient cohort in the usual care clinics. Thus, approximately 800 patients will be included in the study. Baseline, follow-up, and outcome data will be obtained from electronic records.
Study-defined medications will be finalized by the study team and quality committees. These medications are identified based upon previous work and are prescribed with reasonable frequency, commonly have gaps in laboratory monitoring, carry significant risk of toxicity, and are of interest to the participating HMOs because of prior and potential adverse events. We anticipate focusing on baseline monitoring for new prescriptions. New starts will be defined as patients with an index prescription but no other dispense of that medication in the prior 6 months.
Lab Alert will assess the effectiveness of a patient-specific electronic medical record (EMR) in-basket reminder to the primary care provider (PCP) (EMR reminder), an automated recorded voice message to the patient (AVM), pharmacy team outreach (Pharmacy) to increase the proportion of patients receiving all guideline-based laboratory monitoring, when compared to usual care (UC). If any intervention is better than UC, Lab Alert will assess and compare their effectiveness and costs. The study also will evaluate PCP and patient experiences with the intervention in order to refine the interventions in the future.
- Conditions
- Safety
- Being tested
- Electronic Medical Record (EMR) to clinician's in-basket, Automated Voice Message (AVM) reminder to patient's phone, Pharmacy Team phone call-letter followup
- Keywords
- Baseline, Laboratory, Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Medical Record (EMR) to clinician's in-basketDevice
Automated Voice Message (AVM) reminder to patient's phoneDevice
Pharmacy Team phone call-letter followupProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Garfield Memorial Fund
- Investigators
- Adrianne C. Feldstein, MD, MS, Principal investigator, Northwest Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256386
- Sponsor's protocol ID
- 101-9520 Garfield Mem Trust
- Status last verified
- Nov 2005
- First submitted
- 17 Nov 2005
- Last updated
- 30 Nov 2006
- Results posted
- No
Publications
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.
PubMed 1987460Beard 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.
PubMed 1504448Classen 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.
PubMed 9002492Burnum 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.
PubMed 937927Leape 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.
PubMed 1824793Bates 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.
PubMed 7791255Thomas 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.
PubMed 10718351Gandhi 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.
PubMed 10718894Hulse RK, Clark SJ, Jackson JC, Warner HR, Gardner RM. Computerized medication monitoring system. Am J Hosp Pharm. 1976 Oct;33(10):1061-4.
PubMed 973633Lesar TS, Briceland L, Stein DS. Factors related to errors in medication prescribing. JAMA. 1997 Jan 22-29;277(4):312-7.
PubMed 9002494Graham 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.
PubMed 11497537Abookire SA, Karson AS, Fiskio J, Bates DW. Use and monitoring of
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.
PubMed 10333901Beach 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.
PubMed 10346718Raebel 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.
PubMed 16423101
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety
- ClinicalTrials.gov ID
- NCT00256386
- Acronym / sponsor ID
- 101-9520 Garfield Mem Trust
- Conditions
- Safety
- Keywords
- Baseline, Laboratory, Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Garfield Memorial Fund
- Study start
- Jan 2004
- Study completion
- Mar 2005
- First posted
- 21 Nov 2005 (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.
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).
Detailed description
Many of the medications that clinicians prescribe to prevent or treat disease can result in unanticipated and unintended toxic effects. Many national clinical guidelines recommend baseline and periodic laboratory monitoring to avoid adverse drug events. Our Safety in Prescribing project (SIP) has found many significant gaps in medication safety. Lab Alert will evaluate electronic tools to improve Kaiser Permanente's performance in laboratory monitoring to avoid adverse drug events. We will enroll patients who are taking high-risk medications and who have not received laboratory monitoring. The primary outcome of this 2-year study is the proportion of patients who receive guideline-based laboratory monitoring at 1 and 3 weeks post-intervention.
Fifteen primary care clinics will be randomly assigned to: (1) usual care (UC) (2) electronic message reminder (EMR) (3) automated voice message (AVM) (4) pharmacy outreach team (Pharmacy). The reminders will notify of the patient's need for guideline-specified laboratory testing due to medication use. Using electronic data, patients with PCPs assigned to intervention clinics who are on study-specified medications will be identified and screened for exclusions, to yield 600 patients (200 per intervention group). Patients will be assigned to the treatment groups on the basis of the condition assigned to their usual clinic. After the intervention and observation periods, and using the same time frame and inclusion and exclusion criteria used to identify the patients in the intervention arms, we will retrospectively identify a comparison 200-patient cohort in the usual care clinics. Thus, approximately 800 patients will be included in the study. Baseline, follow-up, and outcome data will be obtained from electronic records.
Study-defined medications will be finalized by the study team and quality committees. These medications are identified based upon previous work and are prescribed with reasonable frequency, commonly have gaps in laboratory monitoring, carry significant risk of toxicity, and are of interest to the participating HMOs because of prior and potential adverse events. We anticipate focusing on baseline monitoring for new prescriptions. New starts will be defined as patients with an index prescription but no other dispense of that medication in the prior 6 months.
Lab Alert will assess the effectiveness of a patient-specific electronic medical record (EMR) in-basket reminder to the primary care provider (PCP) (EMR reminder), an automated recorded voice message to the patient (AVM), pharmacy team outreach (Pharmacy) to increase the proportion of patients receiving all guideline-based laboratory monitoring, when compared to usual care (UC). If any intervention is better than UC, Lab Alert will assess and compare their effectiveness and costs. The study also will evaluate PCP and patient experiences with the intervention in order to refine the interventions in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 18 years of age or older
- 12-month HMO membership
- drug benefit coverage
- has telephone number
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Electronic Medical Record (EMR) to clinician's in-basket | Device | – |
| Automated Voice Message (AVM) reminder to patient's phone | Device | – |
| Pharmacy Team phone call-letter followup | Procedure or surgery | – |
Primary outcome
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.
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 30 Nov 2006.
- Background: PubMed 1987460Brennan 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.
- Background: PubMed 1504448Beard 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.
- Background: PubMed 9002492Classen 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.
- Background: PubMed 937927Burnum 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.
- Background: PubMed 1824793Leape 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.
- Background: PubMed 7791255Bates 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.
- Background: PubMed 10718351Thomas 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.
- Background: PubMed 10718894Gandhi 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.
- Background: PubMed 973633Hulse RK, Clark SJ, Jackson JC, Warner HR, Gardner RM. Computerized medication monitoring system. Am J Hosp Pharm. 1976 Oct;33(10):1061-4.
- Background: PubMed 9002494Lesar TS, Briceland L, Stein DS. Factors related to errors in medication prescribing. JAMA. 1997 Jan 22-29;277(4):312-7.
- Background: PubMed 11497537Graham 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.
- BackgroundAbookire SA, Karson AS, Fiskio J, Bates DW. Use and monitoring of
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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.
Adrianne C. Feldstein, MD, MS principal investigator
Northwest Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Medical Record (EMR) to clinician's in-basket, Automated Voice Message (AVM) reminder to patient's phone and Pharmacy Team phone call-letter followup in people with Safety, run by Kaiser Permanente at 1 site 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 5 inclusion and 4 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 30 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.. The study lists 3 primary outcomes in all. 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 NCT00256386, which also lists 44 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 30 Nov 2006.