Polypharmacy Clinical Trial
Official title:
Spread and Scale of a Polypharmacy App to Improve Health Outcomes of Older Adults Living in New Brunswick Nursing Homes: an Effectiveness-Implementation Hybrid Type 2 Study Design for a Stepped Wedge Cluster Randomized Trial
Verified date | February 2021 |
Source | Centre for Innovation and Research in Aging, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Medication overload is an epidemic causing widespread harm, particularly to older Canadians. While most prescriptions are intended to help people live longer and healthier lives, taking multiple medications can increase frailty, and lead to dangerous side effects.This is a mixed-methods study to determine the impact of MedReviewRx on prescribing in New Brunswick Nursing Homes (NBNHs). MedReviewRx is an application which allows MedSafer to analyze a person's medications and medical conditions and produce a report with suggestions for how to simplify medications and make them safer. MedSafer reports will be used to assist physicians and pharmacists identify potentially inappropriate medications (PIMs) and conduct medication reviews in NBNHs. The prevalence of PIMs in NBNHs before MedReviewRx will be measured and the change in PIM use after implementation will be calculated. User experience with MedSafer reports and MedReviewRx will be explored. Patient and Family attitudes towards deprescribing will also be studied. Investigators hypothesize that implementing MedReviewRx in New Brunswick Nursing Homes (NBNHs) will promote deprescribing which will lead to a decrease in the number of PIMs and a decrease in medication costs for older adults living in NBNHs.
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | October 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - All residents of the participating New Brunswick nursing homes (NBNHs) - All residents who are 65 years of age or older - All residents who are taking a potentially inappropriate medication (as identified by MedSafer) Exclusion Criteria: - If both the patient and proxy are unable to complete the survey, the patient will be excluded from the survey component of the study. |
Country | Name | City | State |
---|---|---|---|
Canada | York Care Centre | Fredericton | New Brunswick |
Canada | Faubourg du Mascaret | Moncton | New Brunswick |
Canada | Spencer Nursing Home | Moncton | New Brunswick |
Canada | Shannex Embassy Hall | Quispamsis | New Brunswick |
Canada | Loch Lomond Villa | Saint John | New Brunswick |
Lead Sponsor | Collaborator |
---|---|
Centre for Innovation and Research in Aging, Canada | Horizon Health Network, McGill University Health Centre/Research Institute of the McGill University Health Centre, Missing Link Technologies, New Brunswick Community College |
Canada,
AlRasheed MM, Alhawassi TM, Alanazi A, Aloudah N, Khurshid F, Alsultan M. Knowledge and willingness of physicians about deprescribing among older patients: a qualitative study. Clin Interv Aging. 2018 Aug 6;13:1401-1408. doi: 10.2147/CIA.S165588. eCollection 2018. — View Citation
Barker D, D'Este C, Campbell MJ, McElduff P. Minimum number of clusters and comparison of analysis methods for cross sectional stepped wedge cluster randomised trials with binary outcomes: A simulation study. Trials. 2017 Mar 9;18(1):119. doi: 10.1186/s13063-017-1862-2. — View Citation
Brath H, Mehta N, Savage RD, Gill SS, Wu W, Bronskill SE, Zhu L, Gurwitz JH, Rochon PA. What Is Known About Preventing, Detecting, and Reversing Prescribing Cascades: A Scoping Review. J Am Geriatr Soc. 2018 Nov;66(11):2079-2085. doi: 10.1111/jgs.15543. Epub 2018 Oct 18. Review. — View Citation
By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015 Nov;63(11):2227-46. doi: 10.1111/jgs.13702. Epub 2015 Oct 8. — View Citation
Caputo A. Trends of psychology-related research on euthanasia: a qualitative software-based thematic analysis of journal abstracts. Psychol Health Med. 2015;20(7):858-69. doi: 10.1080/13548506.2014.993405. Epub 2014 Dec 20. — View Citation
Conklin J, Farrell B, Suleman S. Implementing deprescribing guidelines into frontline practice: Barriers and facilitators. Res Social Adm Pharm. 2019 Jun;15(6):796-800. doi: 10.1016/j.sapharm.2018.08.012. Epub 2018 Sep 18. — View Citation
Dills H, Shah K, Messinger-Rapport B, Bradford K, Syed Q. Deprescribing Medications for Chronic Diseases Management in Primary Care Settings: A Systematic Review of Randomized Controlled Trials. J Am Med Dir Assoc. 2018 Nov;19(11):923-935.e2. doi: 10.1016/j.jamda.2018.06.021. Epub 2018 Aug 11. — View Citation
Djatche L, Lee S, Singer D, Hegarty SE, Lombardi M, Maio V. How confident are physicians in deprescribing for the elderly and what barriers prevent deprescribing? J Clin Pharm Ther. 2018 Aug;43(4):550-555. doi: 10.1111/jcpt.12688. Epub 2018 Apr 22. — View Citation
Gallagher P, Barry P, O'Mahony D. Inappropriate prescribing in the elderly. J Clin Pharm Ther. 2007 Apr;32(2):113-21. Review. — View Citation
Gutiérrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero Á, Inzitari M, Martínez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3. — View Citation
Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020 Jun 1;49(3):979-995. doi: 10.1093/ije/dyz237. — View Citation
Kim H, Park YH, Jung YI, Choi H, Lee S, Kim GS, Yang DW, Paik MC, Lee TJ. Evaluation of a technology-enhanced integrated care model for frail older persons: protocol of the SPEC study, a stepped-wedge cluster randomized trial in nursing homes. BMC Geriatr. 2017 Apr 18;17(1):88. doi: 10.1186/s12877-017-0459-7. Erratum in: BMC Geriatr. 2017 May 15;17 (1):106. — View Citation
Kim J, Parish AL. Polypharmacy and Medication Management in Older Adults. Nurs Clin North Am. 2017 Sep;52(3):457-468. doi: 10.1016/j.cnur.2017.04.007. Review. — View Citation
Lavan AH, Gallagher P. Predicting risk of adverse drug reactions in older adults. Ther Adv Drug Saf. 2016 Feb;7(1):11-22. doi: 10.1177/2042098615615472. Review. — View Citation
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. — View Citation
O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16. Review. Erratum in: Age Ageing. 2018 May 1;47(3):489. — View Citation
Sirois C, Ouellet N, Reeve E. Community-dwelling older people's attitudes towards deprescribing in Canada. Res Social Adm Pharm. 2017 Jul - Aug;13(4):864-870. doi: 10.1016/j.sapharm.2016.08.006. Epub 2016 Aug 31. — View Citation
Thillainadesan J, Gnjidic D, Green S, Hilmer SN. Impact of Deprescribing Interventions in Older Hospitalised Patients on Prescribing and Clinical Outcomes: A Systematic Review of Randomised Trials. Drugs Aging. 2018 Apr;35(4):303-319. doi: 10.1007/s40266-018-0536-4. Review. — View Citation
Thompson W, Farrell B. Deprescribing: what is it and what does the evidence tell us? Can J Hosp Pharm. 2013 May;66(3):201-2. — View Citation
van der Sluijs R, Fiddelers AAA, Waalwijk JF, Reitsma JB, Dirx MJ, den Hartog D, Evers SMAA, Goslings JC, Hoogeveen WM, Lansink KW, Leenen LPH, van Heijl M, Poeze M. The impact of the Trauma Triage App on pre-hospital trauma triage: design and protocol of the stepped-wedge, cluster-randomized TESLA trial. Diagn Progn Res. 2020 Jun 18;4:10. doi: 10.1186/s41512-020-00076-1. eCollection 2020. — View Citation
Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013 Jul;66(7):752-8. doi: 10.1016/j.jclinepi.2013.01.009. Epub 2013 Mar 22. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost savings | Cost savings analysis related to cost saved from medications (actual price of the medication as well as dispensing fees) balanced with the cost of deployment of MedSafer including maintaining the program with updates and user support. | 1 year | |
Other | Patient and family attitudes about deprescribing | Patient and family attitudes about deprescribing will be reported using survey responses collected from the revised Patient Attitude Towards Deprescribing (rPATD) questionnaires. Questionnaires contain 19 questions (caregiver version) and 22 questions (older adult version) with answers ranging from "strongly agree" to strongly disagree". | 90-days following the first intervention cycle (9-months) | |
Other | Patient and family attitudes about deprescribing | Patient and family attitudes about deprescribing will be reported using survey responses collected from the revised Patient Attitude Towards Deprescribing (rPATD) questionnaires. Questionnaires contain 19 questions (caregiver version) and 22 questions (older adult version) with answers ranging from "strongly agree" to strongly disagree". | 90-days following the second intervention cycle (6-months) | |
Other | Patient and family attitudes about deprescribing | Patient and family attitudes about deprescribing will be reported using survey responses collected from the revised Patient Attitude Towards Deprescribing (rPATD) questionnaires. Questionnaires contain 19 questions (caregiver version) and 22 questions (older adult version) with answers ranging from "strongly agree" to strongly disagree". | 90-days following the third intervention cycle (3-months) | |
Primary | Impact of MedReviewRx on the prevalence of potentially inappropriate medications (PIMs) in New Brunswick nursing homes (NBNHs). | The impact on PIMs will be determined by the proportion of nursing home residents who have one or more PIMs reduced or stopped after the treating physician receives a MedSafer report | Baseline to 3 months | |
Secondary | Proportion of patients with one or more PIM reduced or stopped following each cycle. | Sustainability | 90-days following the first intervention cycle (9-months) | |
Secondary | Proportion of patients with one or more PIM reduced or stopped following each cycle. | Sustainability | 90-days following the second intervention cycle (6-months) | |
Secondary | Proportion of patients with one or more PIM reduced or stopped following each cycle. | Sustainability | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of deaths | Safety data | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of deaths | Safety data | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of deaths | Safety data | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of fractures | Safety data | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of fractures | Safety data | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of fractures | Safety data | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of falls | Safety data | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of falls | Safety data | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of falls | Safety data | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of restraints | Safety data | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of restraints | Safety data | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of restraints | Safety data | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of transfers to the hospital | Safety data | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of transfers to the hospital | Safety data | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of transfers to the hospital | Safety data | 90-days following the third intervention cycle (3-months) | |
Secondary | Change in functional status based on interRAI activities of daily living (ADL) scores. | The ADL Hierarchy ranges from 0 (no impairment) to 6 (total dependence) | 90-days following the first intervention cycle (9-months) | |
Secondary | Change in functional status based on interRAI activities of daily living (ADL) scores. | The ADL Hierarchy ranges from 0 (no impairment) to 6 (total dependence) | 90-days following the second intervention cycle (6-months) | |
Secondary | Change in functional status based on interRAI activities of daily living (ADL) scores. | The ADL Hierarchy ranges from 0 (no impairment) to 6 (total dependence) | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of participants with transfers out of the institution (return to independent living) | Safety data | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of participants with transfers out of the institution (return to independent living) | Safety data | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of participants with transfers out of the institution (return to independent living) | Safety data | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form | 0 (Behavior not present), 1 (Behavior present, consistent with usual functioning), 2 (Behavior present, appears different from usual functioning) | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form | 0 (Behavior not present), 1 (Behavior present, consistent with usual functioning), 2 (Behavior present, appears different from usual functioning) | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form | 0 (Behavior not present), 1 (Behavior present, consistent with usual functioning), 2 (Behavior present, appears different from usual functioning) | 90-days following the third intervention cycle (3-months) | |
Secondary | Number of changes from baseline in composite safety data | Deaths, fractures, falls, use of restraints, transfers to hospital, pressure ulcers and stage, in-dwelling catheter use, change in functional status, transfers out of the institution, episodes of delirium. | 90-days following the first intervention cycle (9-months) | |
Secondary | Number of changes from baseline in composite safety data | Deaths, fractures, falls, use of restraints, transfers to hospital, pressure ulcers and stage, in-dwelling catheter use, change in functional status, transfers out of the institution, episodes of delirium. | 90-days following the second intervention cycle (6-months) | |
Secondary | Number of changes from baseline in composite safety data | Deaths, fractures, falls, use of restraints, transfers to hospital, pressure ulcers and stage, in-dwelling catheter use, change in functional status, transfers out of the institution, episodes of delirium. | 90-days following the third intervention cycle (3-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured by survey responses. | Open ended questions, multiple choice questions and Likert scales: 1 (not at all) to 10 (very much), strongly disagree to strongly agree, very unlikely to very likely. | 90-days following the first intervention cycle (9-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured by survey responses. | Open ended questions, multiple choice questions and Likert scales: 1 (not at all) to 10 (very much), strongly disagree to strongly agree, very unlikely to very likely. | 90-days following the second intervention cycle (6-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured by survey responses. | Open ended questions, multiple choice questions and Likert scales: 1 (not at all) to 10 (very much), strongly disagree to strongly agree, very unlikely to very likely. | 90-days following the third intervention cycle (3-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured through interview data. | Open ended questions | 90-days following the first intervention cycle (9-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured through interview data. | Open ended questions | 90-days following the second intervention cycle (6-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured through interview data. | Open ended questions | 90-days following the third intervention cycle (3-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team. | Operationalizing testing | 90-days following the first intervention cycle (9-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team. | Operationalizing testing | 90-days following the second intervention cycle (6-months) | |
Secondary | User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team. | Operationalizing testing | 90-days following the third intervention cycle (3-months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03688542 -
Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module
|
N/A | |
Completed |
NCT02545257 -
Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care
|
N/A | |
Withdrawn |
NCT01932632 -
Medication Minimization for Long-term Care Residents
|
N/A | |
Recruiting |
NCT04615065 -
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
|
||
Active, not recruiting |
NCT04181879 -
Appropriate Polypharmacy in Older People in Primary Care
|
N/A | |
Not yet recruiting |
NCT03283735 -
Deprescribing: a Portrait and Out-comes of the Reduction of Polypharmacy in Portugal
|
N/A | |
Completed |
NCT02918058 -
Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults
|
N/A | |
Completed |
NCT03655405 -
Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents
|
N/A | |
Completed |
NCT04575155 -
Development & Pilot of the Technology-Enabled Alliance for Medication Therapy Management
|
N/A | |
Withdrawn |
NCT05816967 -
Rationalisation of Polypharmacy by the RASP-instrument and Discharge Counselling of Geriatric Inpatients
|
N/A | |
Completed |
NCT05616689 -
Bundled Hyperpolypharmacy Deprescribing
|
N/A | |
Terminated |
NCT04055896 -
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting
|
N/A | |
Active, not recruiting |
NCT03052192 -
Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.
|
||
Completed |
NCT02866799 -
Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
|
N/A | |
Completed |
NCT01732302 -
Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients
|
N/A | |
Enrolling by invitation |
NCT05053815 -
Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting
|
||
Active, not recruiting |
NCT04585191 -
Reducing Treatment Risk in Older Adults With Diabetes
|
N/A | |
Active, not recruiting |
NCT04120480 -
Effectiveness of PGx Testing
|
N/A | |
Recruiting |
NCT05609981 -
Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug Dispensing Systems
|
N/A | |
Recruiting |
NCT05501223 -
Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic
|
N/A |