Deprescribing: a Portrait and Out-comes of the Reduction of Polypharmacy in Portugal

NCT03283735 | Unknown DMC

• 1 other identifier: UBIMED2017
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polypharmacy; Deprescriptions

Keywords

Deprescribing; Polypharmacy; Elderly; Enablement; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life after the intervention with EQ-5D

  six months

Study Arms (2)

Elderly Enablement

EXPERIMENTAL

The investigators will give enablement tools and talks with their GPs about how to issue the problem of polypharmacy.

Behavioral: Elderly Enablement

Control

NO INTERVENTION

This will be the control group.

Interventions

Elderly Enablement BEHAVIORAL

The information given in this group will result from the knowledge obtained in previous phase of the study in the shape of small leaflets and other information materials to be made according to the best practice, to be given and remembered at scheduled times to the intervention group

Elderly Enablement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients attending to the primary care consultation in the selected health centres.

You may not qualify if:

• Being acutely unwell in the last three weeks
• Refuse to participate

Sponsors & Collaborators

• University of Beira Interior: lead

Related Publications (26)

• 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.

  PMID: 27984921 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

• 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.

  PMID: 26951120 BACKGROUND

• 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.

  PMID: 27935150 BACKGROUND

• 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.

  PMID: 27663392 BACKGROUND

• Sivagnanam G. Deprescription: The prescription metabolism. J Pharmacol Pharmacother. 2016 Jul-Sep;7(3):133-7. doi: 10.4103/0976-500X.189680.

  PMID: 27651709 BACKGROUND

• Sluggett JK, Ilomaki 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.

  PMID: 27965033 BACKGROUND

• 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.

  PMID: 25849568 BACKGROUND

• 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. doi: 10.5694/mja14.00146.

  PMID: 25296059 BACKGROUND

• 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.

  PMID: 26966056 BACKGROUND

• 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.

  PMID: 25385826 BACKGROUND

• 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.

  PMID: 24028356 BACKGROUND

• 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.

  PMID: 26767619 BACKGROUND

• 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. doi: 10.1007/s40266-016-0410-1.

  PMID: 27785734 BACKGROUND

• 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.

  PMID: 23912674 BACKGROUND

• 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. No abstract available.

  PMID: 27260319 BACKGROUND

• 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.

  PMID: 24661192 BACKGROUND

• 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.

  PMID: 27151653 BACKGROUND

• 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.

  PMID: 27077231 BACKGROUND

• 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.

  PMID: 25083200 BACKGROUND

• 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. doi: 10.5694/mja13.00200.

  PMID: 25296058 BACKGROUND

• 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.

  PMID: 27493719 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

• 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.

  PMID: 27266865 BACKGROUND

• 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.

  PMID: 22500541 BACKGROUND

• Simoes PA, Santiago LM, Simoes JA. Deprescribing in primary care in Portugal (DePil17-20): a three-phase observational and experimental study protocol. BMJ Open. 2018 Jul 17;8(7):e019542. doi: 10.1136/bmjopen-2017-019542.

  PMID: 30018092 DERIVED

Study Officials

• Pedro Augusto Simões, Master

  University of Beira Interior

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Augusto Simões, Master

CONTACT

+351968384396; pedro.augusto.simoes@ubi.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This phase of the study is expected to start in September 2019 and will last for 6 months. Two groups will be created with a minimum of 190 patients each, one of which will be composed from patients from the region of Aveiro, Coimbra and Guarda and the other from patients from the region of Castelo Branco, Leiria and Viseu. In the intervention group the investigators will give enablement tools and talks with their GPs about how to issue the problem of polypharmacy. The information given in this group will result from the knowledge obtained in phase II in the shape of small leaflets and other information materials to be made according to the best practice, to be given and remembered at scheduled times to the intervention group.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 14, 2017
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share