Polypharmacy Clinical Trial
— DePil17-20Official title:
Deprescribing: a Portrait and Out-comes of the Reduction of Polypharmacy in Portugal
This study protocol comprises three phases. The first two phases will be nationwide and aim to evaluate the prevalence and patterns of polypharmacy and assess the barriers and facilitators of deprescribing perceived by older adults, as well as their willingness to be deprescribed and to self-medicate. The third and last phase will be a non-pharmacological randomised clinical study to measure the impact of enablement of older adults in their willingness to be deprescribed and related quality of life.
Status | Not yet recruiting |
Enrollment | 380 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Patients attending to the primary care consultation in the selected health centres. Exclusion Criteria: - Being acutely unwell in the last three weeks - Refuse to participate |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Beira Interior |
Beer C, Loh PK, Peng YG, Potter K, Millar A. A pilot randomized controlled trial of deprescribing. Ther Adv Drug Saf. 2011 Apr;2(2):37-43. doi: 10.1177/2042098611400332. — View Citation
Farrell B, Tsang C, Raman-Wilms L, Irving H, Conklin J, Pottie K. What are priorities for deprescribing for elderly patients? Capturing the voice of practitioners: a modified delphi process. PLoS One. 2015 Apr 7;10(4):e0122246. doi: 10.1371/journal.pone.0122246. eCollection 2015. — View Citation
Galazzi A, Lusignani M, Chiarelli MT, Mannucci PM, Franchi C, Tettamanti M, Reeve E, Nobili A. Attitudes towards polypharmacy and medication withdrawal among older inpatients in Italy. Int J Clin Pharm. 2016 Apr;38(2):454-61. doi: 10.1007/s11096-016-0279-4. Epub 2016 Mar 7. — View Citation
Gnjidic D, Le Couteur DG, Kouladjian L, Hilmer SN. Deprescribing trials: methods to reduce polypharmacy and the impact on prescribing and clinical outcomes. Clin Geriatr Med. 2012 May;28(2):237-53. doi: 10.1016/j.cger.2012.01.006. Epub 2012 Feb 21. Review. — View Citation
Halvorsen KH, Selbaek G, Ruths S. Trends in potentially inappropriate medication prescribing to nursing home patients: comparison of three cross-sectional studies. Pharmacoepidemiol Drug Saf. 2017 Feb;26(2):192-200. doi: 10.1002/pds.4142. Epub 2016 Dec 9. — View Citation
Jansen J, Naganathan V, Carter SM, McLachlan AJ, Nickel B, Irwig L, Bonner C, Doust J, Colvin J, Heaney A, Turner R, McCaffery K. Too much medicine in older people? Deprescribing through shared decision making. BMJ. 2016 Jun 3;353:i2893. doi: 10.1136/bmj.i2893. — View Citation
Machado-Alba JE, Gaviria-Mendoza A, Machado-Duque ME, Chica L. Deprescribing: a new goal focused on the patient. Expert Opin Drug Saf. 2017 Feb;16(2):111-112. doi: 10.1080/14740338.2017.1273347. Epub 2016 Dec 26. — View Citation
Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Sep;82(3):583-623. doi: 10.1111/bcp.12975. Epub 2016 Jun 13. Review. — View Citation
Palagyi A, Keay L, Harper J, Potter J, Lindley RI. Barricades and brickwalls--a qualitative study exploring perceptions of medication use and deprescribing in long-term care. BMC Geriatr. 2016 Jan 15;16:15. doi: 10.1186/s12877-016-0181-x. — View Citation
Reeve E, Andrews JM, Wiese MD, Hendrix I, Roberts MS, Shakib S. Feasibility of a patient-centered deprescribing process to reduce inappropriate use of proton pump inhibitors. Ann Pharmacother. 2015 Jan;49(1):29-38. doi: 10.1177/1060028014558290. Epub 2014 Nov 10. — View Citation
Reeve E, Low LF, Hilmer SN. Beliefs and attitudes of older adults and carers about deprescribing of medications: a qualitative focus group study. Br J Gen Pract. 2016 Aug;66(649):e552-60. doi: 10.3399/bjgp16X685669. Epub 2016 Jun 6. — View Citation
Reeve E, Low LF, Shakib S, Hilmer SN. Development and Validation of the Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire: Versions for Older Adults and Caregivers. Drugs Aging. 2016 Dec;33(12):913-928. — View Citation
Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. Review of deprescribing processes and development of an evidence-based, patient-centred deprescribing process. Br J Clin Pharmacol. 2014 Oct;78(4):738-47. doi: 10.1111/bcp.12386. — View Citation
Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. The benefits and harms of deprescribing. Med J Aust. 2014 Oct 6;201(7):386-9. — View Citation
Reeve E, To J, Hendrix I, Shakib S, Roberts MS, Wiese MD. Patient barriers to and enablers of deprescribing: a systematic review. Drugs Aging. 2013 Oct;30(10):793-807. doi: 10.1007/s40266-013-0106-8. Review. — View Citation
Reeve E, Wiese MD, Hendrix I, Roberts MS, Shakib S. People's attitudes, beliefs, and experiences regarding polypharmacy and willingness to Deprescribe. J Am Geriatr Soc. 2013 Sep;61(9):1508-14. doi: 10.1111/jgs.12418. Epub 2013 Aug 26. — View Citation
Ryan R, Hill S. Making rational choices about how best to support consumers' use of medicines: a perspective review. Ther Adv Drug Saf. 2016 Aug;7(4):159-64. doi: 10.1177/2042098616651198. Epub 2016 May 20. Review. — View Citation
Scott IA, Anderson K, Freeman CR, Stowasser DA. First do no harm: a real need to deprescribe in older patients. Med J Aust. 2014 Oct 6;201(7):390-2. — View Citation
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. — 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
Sivagnanam G. Deprescription: The prescription metabolism. J Pharmacol Pharmacother. 2016 Jul-Sep;7(3):133-7. doi: 10.4103/0976-500X.189680. Review. — View Citation
Sluggett JK, Ilomäki J, Seaman KL, Corlis M, Bell JS. Medication management policy, practice and research in Australian residential aged care: Current and future directions. Pharmacol Res. 2017 Feb;116:20-28. doi: 10.1016/j.phrs.2016.12.011. Epub 2016 Dec 10. Review. — View Citation
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. — View Citation
Turner JP, Edwards S, Stanners M, Shakib S, Bell JS. What factors are important for deprescribing in Australian long-term care facilities? Perspectives of residents and health professionals. BMJ Open. 2016 Mar 10;6(3):e009781. doi: 10.1136/bmjopen-2015-009781. — View Citation
Whitman AM, DeGregory KA, Morris AL, Ramsdale EE. A Comprehensive Look at Polypharmacy and Medication Screening Tools for the Older Cancer Patient. Oncologist. 2016 Jun;21(6):723-30. doi: 10.1634/theoncologist.2015-0492. Epub 2016 May 5. Review. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Willingness to be deprescribed after the intervention with open-questions | Assess the enablement of older adults while being Deprescribed in the rise of Willingness to be Deprescribed with two open-questions (one to assess the facilitators and the other to assess the barriers) together with their perception of medication (Beliefs about Medicines Questionnaire). | six months | |
Secondary | Quality of life after the intervention with EQ-5D | Assess the enablement of older adults while being Deprescribed in the rise of their Quality wtih EuroQol Five Dimensions Questionnaire (EQ-5D) | six months |
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