Improving Safety After Hospitalization in Older Persons on High-Risk Medications
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|ClinicalTrials.gov Identifier: NCT02781662|
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Medication Safety||Behavioral: Pharmacist Home-Visit||Not Applicable|
The overarching objective of this research study is to pursue a large randomized controlled trial (RCT) focused on older patients recently discharged from the hospital who have been prescribed medications within one of three high-priority, high-risk drug classes in order to reduce the risk of clinically important medication errors. The National Action Plan for Adverse Drug Event (ADE) Prevention identified three high-priority drug classes as key targets for reducing the risk of drug-related injuries: anticoagulants; diabetes agents (insulin and oral agents); and opioids. These medication classes were chosen because they account for the greatest number of measurable drug-related harms to patients, and a substantial proportion of ADEs associated with these medications is considered preventable. The clinical trial will determine the value of a multifaceted medication error and ADE reduction intervention with a special focus on in-home assessment.
Components of the intervention will include: (1) in-home assessment of high-risk patients by a clinical pharmacist; (2) best-practice, evidence-based medication safety tools and resources targeted to high-risk patients and their caregivers; (3) communication with the primary care team via the electronic health record (EHR) regarding concerns relevant to the use of high-risk medications as well as other medication safety concerns; and (4) a follow-up phone call by the pharmacist to the patient and/or caregiver within 14 days of the home visit. The primary outcome of interest will be clinically important medication errors, a composite outcome comprised of preventable or ameliorable ADEs and potential ADEs due to medication discrepancies or non-adherence. Secondary outcomes will include: (1) preventable or ameliorable ADEs; (2) potential ADEs due to discrepancies or non-adherence; and (3) preventable or ameliorable ADEs judged to be serious, life-threatening, or fatal.
The specific aims for our study are as follows:
Aim 1: To adapt and integrate existing "best-practice," evidence-based medication safety tools, resources, and approaches into a cohesive, multifaceted intervention to reduce the occurrence of clinically important medication errors in older adults recently discharged from the hospital using one or more of the three high-priority, high-risk drug classes (anticoagulants, diabetes agents, and opioids).
Aim 2: To assess the impact of the multifaceted intervention on the incidence of clinically important medication errors employing a randomized controlled trial (RCT) design.
Aim 3: To conduct a process evaluation assessing intervention fidelity, adaptation, mechanisms of impact, essential components, and the influence of contextual factors.
Aim 4: To create: 1) a plan for disseminating study findings to stakeholders who might implement the intervention or make decisions about its future use; and 2) an implementation toolkit for those who wish to implement the intervention in practice.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||361 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Safety After Hospitalization in Older Persons on High-Risk Medications|
|Actual Study Start Date :||July 28, 2016|
|Actual Primary Completion Date :||September 20, 2019|
|Actual Study Completion Date :||September 20, 2019|
No Intervention: Control
No Intervention; Control Arm: Receives Written Medication Information
Behavioral: Pharmacist Home-Visit
Behavioral: Pharmacist Home-Visit
- Clinically important medication errors (preventable drug events and potential adverse events due to medication discrepancies or non-adherence). [ Time Frame: Within 45 days subsequent to hospital discharge ]To assess for the occurrence of clinically important medication errors, the investigators will use methods that they have developed, tested, and validated in previous investigations relating to drug-related incidents. Two pharmacist-investigators, who will not be involved in the intervention, will screen for signals of possible clinically important medication errors in the patient's electronic health record and in a structured telephone interview. The semi-structured telephone interview will be conducted according to the approach used by Forester, et. al (Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003; 138(3):161-167).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781662
|Principal Investigator:||Jerry H Gurwitz, MD||Meyers Primary Care Institute, University of Massachusetts Medical School|