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Improving Safety After Hospitalization in Older Persons on High-Risk Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02781662
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Reliant Medical Group
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jerry Gurwitz, University of Massachusetts, Worcester

Brief Summary:
This study evaluates an intervention to reduce medication errors and adverse drug events in older adults who have recently been discharged from the hospital and prescribed anticoagulants, diabetes agents, or opioids. Half of the study participants will receive the intervention, while the other half will receive usual care.

Condition or disease Intervention/treatment Phase
Medication Safety Behavioral: Pharmacist Home-Visit Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No Intervention; Control Arm: Receives Written Medication Information
Experimental: Intervention
Behavioral: Pharmacist Home-Visit
Behavioral: Pharmacist Home-Visit



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 years of age and having been prescribed one of the three high-risk drug categories (anticoagulants, diabetes agents, and opioids) at the time of hospital discharge and must meet one or more of following screening Items:

    • Prescribed >2 high-risk medications
    • Low health literacy
    • Caregiver (an affirmative response to "Have you received assistance from one or more caregivers over the past 4 weeks?").
    • Low adherence
    • Using >7 different medications

Exclusion Criteria:

  • Plans to enroll in hospice upon discharge.
  • Discharged for a psychiatric condition.
  • Discharged to a skilled nursing facility, rehabilitation hospital, or nursing home.
  • Patient is not capable of providing informed consent, and a proxy is not available.

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Massachusetts, Worcester
Reliant Medical Group
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Layout table for investigator information
Principal Investigator: Jerry H Gurwitz, MD Meyers Primary Care Institute, University of Massachusetts Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jerry Gurwitz, Executive Director, Meyers Primary Care Institute, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02781662    
Other Study ID Numbers: R18HS023774 ( U.S. AHRQ Grant/Contract )
R18HS023774 ( U.S. AHRQ Grant/Contract )
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jerry Gurwitz, University of Massachusetts, Worcester:
Safety
Hospitalization
Older Persons
High-Risk