Vasilevskis 2019.

Study name	A patient‐centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed‐MEDS randomized controlled trial
Methods	Randomised controlled trial
Participants	Inclusion criteria: Adults, aged 50 and older Hospitalised at Vanderbilt University Medical Center (VUMC) and referred to post‐acute care (PAC) at one of 20 skilled nursing facilities (SNFs) or 2 inpatient rehabilitation facilities (IPRs) in the Middle Tennessee area The patient has 5 or more medications on their pre‐hospital admission medication list (to include all prescription and over‐the‐counter medications, both scheduled and as needed) A home residence in one of 9 surrounding counties of VUMC to facilitate a home visit during the study follow‐up phase 90 days after PAC discharge Exclusion criteria: Homeless or incarcerated Do not have a working telephone Resides in long‐term care prior to hospitalisation Has a limited (< 6 months) life expectancy per medical record documentation (e.g. stage 4 metastatic cancer diagnosis, hospice referral) Currently enrolled in a drug trial Expected to discharge from the hospital in less than 48 hours Patients must be able to speak English and have the capacity to provide self‐consent or have a surrogate (i.e. family member or friend) willing to consent on their behalf
Interventions	Intervention group: Shed‐Meds: a patient‐centred de‐prescribing intervention. Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (pharmacist, physician and/or nurse practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and outpatient providers also will be part of the de‐prescribing decision process. De‐prescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Control group: participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes unless a safety issue is identified.
Outcomes	Primary outcome: Change in total number of medications (time frame: 7, 60 and 90 days after discharge from the skilled nursing facility) Secondary outcomes: Change in functional health status (time frame: 7 and 90 days after discharge from the skilled nursing facility) assessed by the Vulnerable Elders Survey (VES‐13) Change in Drug Burden Index: anticholinergic and sedative drug burden of prescribed medications (time frame: 90 days after discharge from the skilled nursing facility) Change in medication adherence (time frame: 60 and 90 days after discharge from the skilled nursing facility) by use of the Adherence to Refills and Medication Scale (ARMS)
Starting date	Patient enrollment for the Shed‐MEDS trial began March 2017 and is scheduled to end October 2020
Contact information	Principal Investigator: Sandra F Simmons, PhD Vanderbilt University Medical Center
Notes	—

Abbreviations:

ACS: acute coronary syndrome
ADL: activities of daily living
ALT: alanine transaminase
CRP: C‐reactive protein
ED: emergency department
EQ‐5D: standardised instrument of the EuroQol Group used to measure health outcomes
GFR/eGFR: glomerular filtration rate/estimated glomerular filtration rate
GP: general practitioner
HDU: high‐dependency unit
HRQoL: health‐related quality of life
IADL: instrumental activities of daily living
ICU: intensive care unit
IMM: integrated medicine management
INR: international normalised ratio
MAI: Medication Appropriateness Index
MCH: mean corpuscular haemoglobin
MCV: mean corpuscular volume
NGAL: neutrophil gelatinase‐associated lipocalin
PEF‐FB‐9: "Fragebogen zur Partizipativen Ent‐scheidungsfindung (revidierte 9‐Item‐Fassung)" ‐ tool used to measure patient empowerment
PIM: potentially inappropriate medication
RCT: randomised controlled trial
TSQM: Treatment Satisfaction Questionnaire for Medication