Drug Reduction in Older Patients: The DROP Trial

NCT03722017 | Completed Results DMC

• 1 other identifier: IIR 17-033
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Project Objectives: The proposed randomized, controlled trial will evaluate the effects of procedures to reduce medications among hospitalized older Veterans discharged to nursing homes using an hybrid study design to inform future efforts to spread it across VA. Project Background/Rationale: Patients discharged to nursing homes for short stays represent the largest group of Medicare beneficiaries discharged to post-hospital services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a VA-funded Quality Improvement Award and a Centers for Medicare and Medicaid Services (CMS) Innovation Award, both of which provide strong results related to the occurrence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed and pilot-tested a patient-centered deprescribing set of procedures combined with standardized questions for eight geriatric syndromes to be implemented in the hospital and monitored during the nursing home stay. Project Methods: The investigators propose an innovative hybrid study design that will be conducted in one VA hospital. The goal of the proposed DROP intervention is to safely deprescribe medications, as defined by reducing doses or stopping medications, based on a combination of clinical criteria and Veteran preferences. This randomized, controlled trial conducted over three years will evaluate the effects of this hospital-based intervention on medication use, geriatric syndromes, and health status across Veterans' care transitions from the hospital to nursing home to home to include a 90-day follow-up period after leaving the nursing home. The hypothesis is that reducing medications for older Veterans will favorably impact geriatric syndromes. Additionally, the investigators aim to understand Veteran, both VA and non-VA provider and system-level factors that help or hinder how well the deprescribing procedures are implemented to inform future clinical uptake and dissemination throughout the VA.

Conditions

Geriatric Assessment; Frail Elderly; Skilled Nursing Facilities; Patient-centered Care

Keywords

deprescriptions; polypharmacy; potentially inappropriate medication; medication adherence

Outcome Measures

Primary Outcomes (1)

• Total Number of Medications

  The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.

  Hospital Discharge, SNF Discharge, and 90-days after SNF Discharge

Secondary Outcomes (1)

• Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug Burden

  Hospital Discharge, SNF Discharge, and 90 Days after SNF Discharge

Study Arms (2)

Control--usual care

NO INTERVENTION

Medication History: All participants / surrogates will receive a structured interview and chart review by the study Pharmacist or Nurse Practitioner at enrollment to determine: Medications: Medications will include ANY medication with the potential for continuation at the time of hospital discharge to include pre-hospital medications, \[OTC medications\] and active in-hospital medications. Pre-hospital \[and OTC\] medications will be confirmed by Veteran/surrogate interview and pharmacy refills. If a Veteran is admitted from SNF (short-term stay), the investigators will request a copy of the Medication Administration Record (MAR) for the past 30 days. Current medications will be defined as those taken within 30 days prior to the index (enrollment) hospitalization event.

Intervention--deprescribing protocol

EXPERIMENTAL

In addition to a medication history, a study Pharmacist or Nurse Practitioner will review the reconciled total enrollment medication list. The following information will be ascertained for each medication: (1) Medication Indication; and, (2) Deprescribing rationale: Rationales for deprescribing (i.e., stopping or reducing dose) will be assessed for each medication. Deprescribing Recommendations: For each medication recommended for deprescribing, the deprescribing action will be specified as: (1) Stop prior to hospital discharge without need for monitoring; (2) Stop prior to hospital discharge with symptoms/physiologic monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until medication is stopped; (5) Reduce to lower dose without need for monitoring; (6) Reduce to lower dose with symptoms/physiologic monitoring.

Other: Deprescribing intervention

Interventions

Deprescribing intervention OTHER

In addition to a medication history, a study Pharmacist or Nurse Practitioner will review the reconciled total enrollment medication list. The following information will be ascertained for each medication: (1) Medication Indication; and, (2) Deprescribing rationale: Rationales for deprescribing (i.e., stopping or reducing dose) will be assessed for each medication. Deprescribing Recommendations: For each medication recommended for deprescribing, the deprescribing action will be specified as: (1) Stop prior to hospital discharge without need for monitoring; (2) Stop prior to hospital discharge with symptoms/physiologic monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until medication is stopped; (5) Reduce to lower dose without need for monitoring; (6) Reduce to lower dose with symptoms/physiologic monitoring.

Intervention--deprescribing protocol

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to SNF (per Physical Therapy and/or Social Work notes)
• Being discharged from the Nashville VA hospital from a medicine or orthopedics team
• Age \> or = 50
• Have polypharmacy, as defined by \> 5 medications based on pre-hospital and in-hospital medications
• Able to self-consent or has a surrogate

You may not qualify if:

• Resides in long-term care
• On hospice
• Not expected to discharge within 48 hours of referral

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Amanda Mixon, MD MSPH MS
• Organization: Tennessee Valley Healthcare System Nashville Campus

amanda.mixon@va.gov

(615) 936-3710

Study Officials

• Amanda S Mixon, MD MSPH MS

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participant and providers involved in their care will not be masked to the intervention, as there is participation of both groups in the deprescribing protocol discussions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will ascertain for each medication: (1) Indication; (2) Deprescribing rationale (i.e., stopping or reducing dose) for each medication. Deprescribing Recommendations will be specified as: (1) Stop prior to hospital discharge, no monitoring; (2) Stop prior to hospital discharge with monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until stopped; (5) Reduce to lower dose without monitoring; (6) Reduce to lower dose with monitoring. Deprescribing will begin prior to hospital discharge. The investigators will incorporate Veteran preferences, communicate with all providers involved in prescribing, create final deprescribing actions, and do enhanced hospital discharge communication.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 26, 2018
• Study Start: October 7, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 27, 2024
• Results First Posted: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available Oct 31, 2021 (study conclusion).
• Access Criteria: A de-identified dataset will be shared upon the finalization of a written agreement between VA Tennessee Valley Healthcare System and the requesting party. This agreement will detail use of the data and prohibit the re-identification of dataset subjects. Our study team will evaluate requests for datasets.

Locations

US (1)