Deprescription of Gabapentinoids in Medical Inpatients

NCT04855578 | Completed

• 1 other identifier: 2021-7353
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

In this trial, investigators will distribute educational brochures with information about the deprescription of gabapentinoids (gabapentin and pregabalin) to inpatients in five medical wards spread across two tertiary-care hospitals in Montréal, Canada. This intervention will be supplemented by a brief information session for medical staff on the wards. This study aims to evaluate the effectiveness of this combined intervention on increasing gabapentinoid deprescription rates among study participants compared to control following hospital discharge.

Conditions

Polypharmacy; Gabapentin; Pregabalin

Keywords

Polypharmacy; Deprescribing; Gabapentin; Pregabalin; Medication Stewardship; High-Value Healthcare; Empowerment; Shared Decision-Making; Adverse Drug Reaction; Elderly; Frailty

Outcome Measures

Primary Outcomes (1)

• Gabapentinoid Discontinuation or Dose Reduction With Intention to Stop

  Proportion of study participants with a gabapentinoid prescription stopped or decreased with intention to stop at the time of follow-up

  8-weeks post-hospital discharge

Secondary Outcomes (6)

• Gabapentinoid Dose Reduction Without Intention to Stop

  8-weeks post-hospital discharge

• Health and Global Function

  At study enrollment and 8-weeks post-hospital discharge

• Chronic Pain Intensity

  At study enrollment and 8-weeks post-hospital discharge

• Cognition

  At study enrollment and 8-weeks post-hospital discharge

• Initiation of New Pain Medication

  8-weeks post-hospital discharge

Study Arms (2)

Usual Medical Care

NO INTERVENTION

During the control period, patients admitted to the study sites who qualify for the trial will receive a pharmacy medication reconciliation as part of usual medical care. Study participants will be informed that the goal of the trial is to evaluate medication use and medication changes after discharge, but they will not be informed that gabapentinoids are specifically being targeted. Medical staff will not receive specific information about the trial, or particular instructions with regards to deprescription during the control period.

In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription

EXPERIMENTAL

During the intervention period, patients admitted to the study sites who qualify for the trial will receive an in-hospital educational brochure. Additionally, the medical team will attend an educational session about gabapentinoid prescription.

Other: In-Hopsital Patient Educational Brochure; Other: Physician Education about Gabapentinoid Prescription

Interventions

In-Hopsital Patient Educational Brochure OTHER

The participant's medication list will be identified from the pharmacy database and validated with the participant's best possible medication history taken at time of admission by a pharmacist. Eligibility will be confirmed by the participant's treating medical team with support from the study investigators. Participants who are enrolled during the intervention phase will receive an educational brochure about the risks of chronic gabapentinoid use, and about how to safely discontinue use. The brochure is written using a sixth-grade vocabulary and has been validated in both English and French for comprehension and readability, including for people with mild cognitive impairment.

In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription

Physician Education about Gabapentinoid Prescription OTHER

An educational session about the purpose of the study and risks of gabapentinoid prescription will be delivered to physicians (staff and medical residents) on each study unit at both sites during the intervention period. The educational session will include a presentation by the chief of the medical service at the monthly teaching rounds, and an electronic message will be sent to all physicians on the medical service. Physicians will also be presented a brief overview of the educational brochure.

In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All inpatients 60 years or older admitted to study units who have a gabapentinoid prescription prior to admission

You may not qualify if:

• Less than 60 years of age
• Known seizure disorder
• Not enrolled in the provincial drug plan (RAMQ)
• Opting out of the provincial drug database (Dossier Santé Québec), which will be confirmed with the patient at the time of recruitment
• Previous enrollment in the study
• Patients expected to die before primary endpoint can be realized (e.g., patients admitted for end-of-life care or prognosis of 3 months or less)
• Unable to consent
• Major neurocognitive disorder, as determined by a previously established diagnosis or interim diagnosis by the medical staff on the ward of moderate severity or worse
• Unable to speak English or French
• Insufficient literacy in English or French
• No means of contacting patient by phone after discharge (e.g. no valid phone number, traveling, planned discharge to a facility without means of reaching by phone, etc.)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (2)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (19)

• Wilson MG, Lee TC, Hass A, Tannenbaum C, McDonald EG. EMPOWERing Hospitalized Older Adults to Deprescribe Sedative Hypnotics: A Pilot Study. J Am Geriatr Soc. 2018 Jul;66(6):1186-1189. doi: 10.1111/jgs.15300. Epub 2018 Mar 1.

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• Bennett MI, Laird B, van Litsenburg C, Nimour M. Pregabalin for the management of neuropathic pain in adults with cancer: a systematic review of the literature. Pain Med. 2013 Nov;14(11):1681-8. doi: 10.1111/pme.12212. Epub 2013 Aug 5.

  PMID: 23915361 BACKGROUND

• Mathieson S, Maher CG, McLachlan AJ, Latimer J, Koes BW, Hancock MJ, Harris I, Day RO, Billot L, Pik J, Jan S, Lin CC. Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med. 2017 Mar 23;376(12):1111-1120. doi: 10.1056/NEJMoa1614292.

  PMID: 28328324 BACKGROUND

• Moore A, Derry S, Wiffen P. Gabapentin for Chronic Neuropathic Pain. JAMA. 2018 Feb 27;319(8):818-819. doi: 10.1001/jama.2017.21547.

  PMID: 29486015 BACKGROUND

• Shanthanna H, Gilron I, Rajarathinam M, AlAmri R, Kamath S, Thabane L, Devereaux PJ, Bhandari M. Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS Med. 2017 Aug 15;14(8):e1002369. doi: 10.1371/journal.pmed.1002369. eCollection 2017 Aug.

  PMID: 28809936 BACKGROUND

• Wiffen PJ, Derry S, Bell RF, Rice AS, Tolle TR, Phillips T, Moore RA. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD007938. doi: 10.1002/14651858.CD007938.pub4.

  PMID: 28597471 BACKGROUND

• Wiffen PJ, Derry S, Moore RA, Aldington D, Cole P, Rice AS, Lunn MP, Hamunen K, Haanpaa M, Kalso EA. Antiepileptic drugs for neuropathic pain and fibromyalgia - an overview of Cochrane reviews. Cochrane Database Syst Rev. 2013 Nov 11;2013(11):CD010567. doi: 10.1002/14651858.CD010567.pub2.

  PMID: 24217986 BACKGROUND

• Jette N, Lix LM, Metge CJ, Prior HJ, McChesney J, Leslie WD. Association of antiepileptic drugs with nontraumatic fractures: a population-based analysis. Arch Neurol. 2011 Jan;68(1):107-12. doi: 10.1001/archneurol.2010.341.

  PMID: 21220681 BACKGROUND

• Toth C. Drug safety evaluation of pregabalin. Expert Opin Drug Saf. 2012 May;11(3):487-502. doi: 10.1517/14740338.2012.677026. Epub 2012 Apr 3.

  PMID: 22468635 BACKGROUND

• Johansen ME. Gabapentinoid Use in the United States 2002 Through 2015. JAMA Intern Med. 2018 Feb 1;178(2):292-294. doi: 10.1001/jamainternmed.2017.7856.

  PMID: 29297045 BACKGROUND

• Kwok H, Khuu W, Fernandes K, Martins D, Tadrous M, Singh S, Juurlink DN, Gomes T. Impact of Unrestricted Access to Pregabalin on the Use of Opioids and Other CNS-Active Medications: A Cross-Sectional Time Series Analysis. Pain Med. 2017 Jun 1;18(6):1019-1026. doi: 10.1093/pm/pnw351.

  PMID: 28340102 BACKGROUND

• Hamer AM, Haxby DG, McFarland BH, Ketchum K. Gabapentin use in a managed medicaid population. J Manag Care Pharm. 2002 Jul-Aug;8(4):266-71. doi: 10.18553/jmcp.2002.8.4.266.

  PMID: 14613419 BACKGROUND

• Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.

  PMID: 25798731 BACKGROUND

• Martin P, Tannenbaum C. A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017 May 4;7(4):e015959. doi: 10.1136/bmjopen-2017-015959.

  PMID: 28473524 BACKGROUND

• Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.

  PMID: 24733354 BACKGROUND

• Martin P, Tannenbaum C. Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. BMC Geriatr. 2017 Jan 31;17(1):37. doi: 10.1186/s12877-017-0432-5.

  PMID: 28143413 BACKGROUND

• McDonald EG, Wu PE, Rashidi B, Forster AJ, Huang A, Pilote L, Papillon-Ferland L, Bonnici A, Tamblyn R, Whitty R, Porter S, Battu K, Downar J, Lee TC. The MedSafer Study: A Controlled Trial of an Electronic Decision Support Tool for Deprescribing in Acute Care. J Am Geriatr Soc. 2019 Sep;67(9):1843-1850. doi: 10.1111/jgs.16040. Epub 2019 Jun 27.

  PMID: 31250427 BACKGROUND

• Gingras MA, Lieu A, Papillon-Ferland L, Lee TC, McDonald EG. Retrospective Cohort Study of the Prevalence of Off-label Gabapentinoid Prescriptions in Hospitalized Medical Patients. J Hosp Med. 2019 Sep;14(9):547-550. doi: 10.12788/jhm.3203.

  PMID: 31112498 BACKGROUND

• Williams J, Gingras MA, Dube R, Lee TC, McDonald EG. Patient empowerment brochures to increase gabapentinoid deprescribing: protocol for the prospective, controlled before-and-after GABA-WHY trial. CMAJ Open. 2022 Jul 12;10(3):E652-E656. doi: 10.9778/cmajo.20210302. Print 2022 Jul-Sep.

  PMID: 35820684 DERIVED

Related Links

• Lyrica - Highlights of prescribing Information
• Neurontin - Highlights of prescribing Information
• Lyrica - Product Monograph
• Neurontin - Product Monograph
• Canadian Deprescribing Network Patient Education Brochure - Gabapentinoids

MeSH Terms

Conditions

Empowerment; Drug-Related Side Effects and Adverse Reactions; Frailty

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily G McDonald, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: It is impossible to blind physicians or study participants. However, medical staff on study units will not be told that gabapentinoids are being targeted by the trial until after the control period has ended. The rationale is that prior knowledge of the goal may bias medical staff in favour of gabapentinoid deprescription. Similarly, participants recruited during the control period will not be told that gabapentinoids are targeted. Since medical staff work in multiple study units in a given year, all units will transition from the control phase to the intervention phase simultaneously to prevent contamination between the control and intervention group. It is impossible to blind outcome assessors at the time of follow-up. Undue influence on the investigator by outcome assessors will be mitigated through the use of a standardized survey that do not depend on the judgement of outcome assessors. Additionally, patient data will be anonymized with a unique identifier prior to analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Emily McDonald, Associate Professor of Medicine

Model Details: Prospective before-and-after study involving five medical wards at two health centres. All wards will start in the control phase and enrolled participants will receive standard therapy. Once the pre-specified target of a 80 participants have been enrolled, all five wards will simultaneously transition into the intervention phase. All subsequently enrolled participants will receive the intervention until another 80 participants are enrolled. The control and intervention phases are expected to take approximately 5 months each.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: May 28, 2021
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year following the primary publication
• Access Criteria: Non-industry researchers

Locations

CA (2)