Adverse Drug Events
Conditions
Keywords
Adverse drug events
Brief summary
We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. For targeted patients, we tested the effect of using pharmacists and pharmacy technicians to obtain an initial medication history. This was studied using a randomized controlled trial of usual care (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy technicians to obtain an admission medication history. The overarching hypothesis was that by leveraging pharmacists and pharmacy technicians we can minimize admission medication history errors and related downstream events.
Detailed description
Importance: Admission medication history (AMH) errors frequently cause medication order errors and patient harm. Objective: To quantify AMH error reduction achieved when pharmacy staff obtain AMHs before admission medication orders (AMO) are placed. Design: Three-arm randomized clinical trial. Setting: Large hospital with community and trainee physicians. Population: 306 enrolled patients with complex medical histories. Interventions: In one intervention arm, pharmacists, and in the second intervention arm, pharmacy technicians obtained initial AMHs prior to admission. They obtained and reconciled medication information from multiple sources. All arms, including the control arm, received usual AMH care. This included common process variation occurring in: accuracy of pre-existing medication histories; nurses' ability to obtain AMHs at hospital admission; and admitting physicians' efforts to verify and order from prior AMHs. Main Outcomes and Measures: The primary outcome was severity-weighted mean AMH error score. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening. Each error was assigned 1, 4 or 9 points, respectively, to calculate severity-weighted AMH and AMO error scores for each patient.
Interventions
OTHERPharmacist obtains admission medication history
OTHERPharmacy technician obtains admission medication history
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Accessed via EHR, were: \>=10 chronic prescription medications * History of acute myocardial infarction or congestive heart failure * Admission from skilled nursing facility * History of transplant, or active anticoagulant, insulin, or narrow therapeutic index medications.
Exclusion criteria
(supersedes inclusion criteria) * Admitted to pediatric, trauma or transplant services with pharmacists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Severity-weighted Admission Medication History (AMH) Error Score | Attempted to obtain the day after admission | The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Severity-Weighted Admission Medication Order (AMO) Error Score | Attempted to obtain the day after admission | The severity-weighted admission medication order (AMO) error score are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. Higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. For each AMH error identified, two physicians independently reviewed the relevant medications ordered at hospital admission in the context of the clinical chart. They classified each AMH error as either resulting in no AMO error, or an AMO error of significant, serious, or life-threatening severity. A third physician adjudicated disagreements. In cases where the admitting physician's knowledge of an AMH error was unclear and the orders clinically reasonable, we determined the AMH error did not lead to any AMO error. Because reviewers needed chart access to determine error severity, there was no practicable way to mask study arm. |
Participant flow
Recruitment details
Eligible participants were medically complex patients admitted to Cedars-Sinai Medical Center, a large university-affiliated hospital, through the emergency department. Enrollment screening occurred Mondays through Thursdays from approximately 11 AM to 8 PM beginning 1/7/2014 through 2/14/2014.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Physicians and nurses obtain admission medication history. | 101 |
| Pharmacist Obtains Home Med hx Pharmacist obtains admission medication history, although usual care practices may also continue. | 103 |
| Pharm Tech Obtains Home Med hx Pharmacy technician obtains admission medication history, although usual care practices may also continue. | 102 |
| Total | 306 |
Baseline characteristics
| Characteristic | Usual Care | Pharmacist Obtains Home Med hx | Pharm Tech Obtains Home Med hx | Total |
|---|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 18 | 72 years STANDARD_DEVIATION 16 | 71 years STANDARD_DEVIATION 16 | 72 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 48 Participants | 54 Participants | 55 Participants | 157 Participants |
| Sex: Female, Male Male | 53 Participants | 49 Participants | 47 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Mean Severity-weighted Admission Medication History (AMH) Error Score
The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening.
Time frame: Attempted to obtain the day after admission
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Severity-weighted Admission Medication History (AMH) Error Score | 23 Mean Severity-weighted AMH Error Score |
| Pharmacist Obtains Home Med hx | Mean Severity-weighted Admission Medication History (AMH) Error Score | 4.1 Mean Severity-weighted AMH Error Score |
| Pharm Tech Obtains Home Med hx | Mean Severity-weighted Admission Medication History (AMH) Error Score | 4.1 Mean Severity-weighted AMH Error Score |
Secondary
Mean Severity-Weighted Admission Medication Order (AMO) Error Score
The severity-weighted admission medication order (AMO) error score are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. Higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. For each AMH error identified, two physicians independently reviewed the relevant medications ordered at hospital admission in the context of the clinical chart. They classified each AMH error as either resulting in no AMO error, or an AMO error of significant, serious, or life-threatening severity. A third physician adjudicated disagreements. In cases where the admitting physician's knowledge of an AMH error was unclear and the orders clinically reasonable, we determined the AMH error did not lead to any AMO error. Because reviewers needed chart access to determine error severity, there was no practicable way to mask study arm.
Time frame: Attempted to obtain the day after admission
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Severity-Weighted Admission Medication Order (AMO) Error Score | 6.9 Mean Severity-Weighted AMO Error Score |
| Pharmacist Obtains Home Med hx | Mean Severity-Weighted Admission Medication Order (AMO) Error Score | 1.5 Mean Severity-Weighted AMO Error Score |
| Pharm Tech Obtains Home Med hx | Mean Severity-Weighted Admission Medication Order (AMO) Error Score | 1.2 Mean Severity-Weighted AMO Error Score |