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

NCT02781662 | Completed DMC

• 1 other identifier: R18HS023774
• Study Type: interventional
• Target: 361
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Safety

Keywords

Safety; Hospitalization; Older Persons; High-Risk

Outcome Measures

Primary Outcomes (1)

• Clinically important medication errors (preventable drug events and potential adverse events due to medication discrepancies or non-adherence).

  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).

  Within 45 days subsequent to hospital discharge

Study Arms (2)

Control

NO INTERVENTION

No Intervention; Control Arm: Receives Written Medication Information

Intervention

EXPERIMENTAL

Behavioral: Pharmacist Home-Visit

Behavioral: Pharmacist Home-Visit

Interventions

Pharmacist Home-Visit BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Reliant Medical Group: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Related Publications (1)

• Gurwitz JH, Kapoor A, Garber L, Mazor KM, Wagner J, Cutrona SL, Singh S, Kanaan AO, Donovan JL, Crawford S, Anzuoni K, Konola TJ, Zhou Y, Field TS. Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):610-618. doi: 10.1001/jamainternmed.2020.9285.

  PMID: 33646267 DERIVED

Study Officials

• Jerry H Gurwitz, MD

  Meyers Primary Care Institute, University of Massachusetts Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 24, 2016
• Study Start: July 28, 2016
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share