Deprescribing in Primary Health Care

NCT03903484 | Completed

• 2 other identifiers: 1024257CAT2017-10
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Medications can help older adults but can also harm them. Frail older adults tend to have many health problems that require treatment, but are also at risk of harm from the medications prescribed. This makes it hard to get older adults the treatments they need and keep them safe from the harms from medications. It ends up that a lot of visits to emergency rooms and hospitals are due to medications, especially for older adults. Previous research has shown the benefits of stopping medications older adults no longer need. Even so, healthcare professionals do not always do this as well as they could. Our goal is to make a collection of resources for pharmacists who work with doctors and nurses in primary settings that will help support older adults as they safely stop medications that are no longer needed. The investigators will use knowledge and tools that are already known and published. In the first six months the team, which includes older adults and their families, pharmacists, doctors, nurses, and healthcare policymakers developed a framework and resource toolbox that pharmacists can use to help older adults stop medications that are no longer needed. In the remaining 10 months, the investigators will use the resource toolbox in primary healthcare teams and nursing homes. Overall, the investigators expect that by using the resources the pharmacists will be able to support patients stop medications they no longer need and help reduce the number of pills people take, reduce drug costs, reduce harms from medication use and improve quality of life for frail older adults and their loved ones.

Conditions

Inappropriate Prescribing; Primary Health Care; Polypharmacy

Keywords

Frailty; Deprescribing

Outcome Measures

Primary Outcomes (4)

• Change in patient's medication appropriateness

  Change in medication appropriateness index before and after the deprescribing intervention

  Before and after deprescribing intervention (counts separated 6 months)

• Healthcare professionals' experience with a collaborative deprescribing intervention

  Mixed methods (qualitative and quantitative) survey measuring satisfaction with deprescribing intervention using a five point Likert scale and open ended questioning.

  At the end of study (approximately 6 months after the start)

• Change in patient quality of life after deprescribing intervention

  Quality of life survey using EuroQol - 5 Dimension (EQ-5D)

  Before and after deprescribing intervention (separated 6 months)

• Patient experience with a collaborative deprescribing intervention

  Qualitative post intervention survey

  Before and after deprescribing intervention (separated 6 months)

Secondary Outcomes (11)

• Change in number of medications

  Before and after deprescribing intervention (counts separated 6 months)

• Change in number of medication administration times per day

  Before and after deprescribing intervention (counts separated 6 months)

• Change in the number of medications used on the anticholinergic cognitive burden scale

  Before and after deprescribing intervention (counts separated 6 months)

• Change in the number of medications used that are targeted for discontinuation in the intervention

  Before and after deprescribing intervention (counts separated 6 months)

• The number of drugs discontinued

  Before and after deprescribing intervention (counts separated 6 months)

Study Arms (1)

Deprescribing intervention

EXPERIMENTAL

Included patient participants will meet with their clinical pharmacist to complete a survey about medication use and quality of life. Then working with the pharmacist, patients will prioritize medications that are no longer needed for discontinuing. A deprescribing plan will be created and the pharmacist will work with the patient to complete this plan. The patient will also be provided resources from the study toolbox to support the patients as they work through deprescribing the targeted drugs. Once the deprescribing plan is completed there will be a patient survey that will capture satisfaction with the deprescribing experience and patient quality of life.

Other: Deprescribing toolbox and intervention

Interventions

Deprescribing toolbox and intervention OTHER

Pharmacist-led deprescribing plan with the patient which will include the patient's deprescribing goals. The intervention advocates for deprescribing according to recognized algorithms and guidelines which will be included in a resource toolbox/website.

Deprescribing intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resides in a study long term care facility or visits a study integrated health care clinic;
• Has a general practitioner or nurse practitioner within the team;
• Has stable/good management of any chronic disease that he/she/they has, i.e., the patient has not been hospitalized for the chronic illness within the last three months
• Has not had a change in the targeted medication in the past three months;
• Is taking any drug on the targeted drug list or a drug that the primary care provider and pharmacist agree should be targeted for deprescribing.

You may not qualify if:

• Is newly diagnosed (i.e., within the last 6 months) with cancer, stroke, myocardial infarction, diabetes, or chronic obstructive pulmonary disease (COPD), and/or the patient has had a recent surgery (i.e., within the last 6 months);
• Is not able to communicate in English;
• Is end-of-life, as determined by the clinician's professional judgment.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator
• Canadian Frailty Network: collaborator
• Horizon Health Network: collaborator

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia (NS), B3L 4P1, Canada

Location

Related Publications (22)

• Mannucci PM, Nobili A; REPOSI Investigators. Multimorbidity and polypharmacy in the elderly: lessons from REPOSI. Intern Emerg Med. 2014 Oct;9(7):723-34. doi: 10.1007/s11739-014-1124-1. Epub 2014 Aug 28.

  PMID: 25164413 BACKGROUND

• Andrew MK, Purcell CA, Marshall EG, Varatharasan N, Clarke B, Bowles SK. Polypharmacy and use of potentially inappropriate medications in long-term care facilities: does coordinated primary care make a difference? Int J Pharm Pract. 2018 Aug;26(4):318-324. doi: 10.1111/ijpp.12397. Epub 2017 Sep 27.

  PMID: 28960614 BACKGROUND

• Fried TR, O'Leary J, Towle V, Goldstein MK, Trentalange M, Martin DK. Health outcomes associated with polypharmacy in community-dwelling older adults: a systematic review. J Am Geriatr Soc. 2014 Dec;62(12):2261-72. doi: 10.1111/jgs.13153.

  PMID: 25516023 BACKGROUND

• Schottker B, Saum KU, Muhlack DC, Hoppe LK, Holleczek B, Brenner H. Polypharmacy and mortality: new insights from a large cohort of older adults by detection of effect modification by multi-morbidity and comprehensive correction of confounding by indication. Eur J Clin Pharmacol. 2017 Aug;73(8):1041-1048. doi: 10.1007/s00228-017-2266-7. Epub 2017 May 24.

  PMID: 28540438 BACKGROUND

• Nossaman VE, Larsen BE, DiGiacomo JC, Manuelyan Z, Afram R, Shukry S, Kang AL, Munnangi S, Angus LDG. Mortality is predicted by Comorbidity Polypharmacy score but not Charlson Comorbidity Index in geriatric trauma patients. Am J Surg. 2018 Jul;216(1):42-45. doi: 10.1016/j.amjsurg.2017.09.011. Epub 2017 Sep 19.

  PMID: 28958648 BACKGROUND

• Fastbom J, Johnell K. National indicators for quality of drug therapy in older persons: the Swedish experience from the first 10 years. Drugs Aging. 2015 Mar;32(3):189-99. doi: 10.1007/s40266-015-0242-4.

  PMID: 25673123 BACKGROUND

• 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.

  PMID: 26446832 BACKGROUND

• 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.

  PMID: 25324330 BACKGROUND

• Holt S, Schmiedl S, Thurmann PA. Potentially inappropriate medications in the elderly: the PRISCUS list. Dtsch Arztebl Int. 2010 Aug;107(31-32):543-51. doi: 10.3238/arztebl.2010.0543. Epub 2010 Aug 9.

  PMID: 20827352 BACKGROUND

• Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007 Aug;63(8):725-31. doi: 10.1007/s00228-007-0324-2. Epub 2007 Jun 7.

  PMID: 17554532 BACKGROUND

• Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, Cohen HJ, Feussner JR. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992 Oct;45(10):1045-51. doi: 10.1016/0895-4356(92)90144-c.

  PMID: 1474400 BACKGROUND

• Hilmer SN, Mager DE, Simonsick EM, Cao Y, Ling SM, Windham BG, Harris TB, Hanlon JT, Rubin SM, Shorr RI, Bauer DC, Abernethy DR. A drug burden index to define the functional burden of medications in older people. Arch Intern Med. 2007 Apr 23;167(8):781-7. doi: 10.1001/archinte.167.8.781.

  PMID: 17452540 BACKGROUND

• Carnahan RM, Lund BC, Perry PJ, Pollock BG, Culp KR. The Anticholinergic Drug Scale as a measure of drug-related anticholinergic burden: associations with serum anticholinergic activity. J Clin Pharmacol. 2006 Dec;46(12):1481-6. doi: 10.1177/0091270006292126.

  PMID: 17101747 BACKGROUND

• Tannenbaum C, Farrell B, Shaw J, Morgan S, Trimble J, Currie J, Turner J, Rochon P, Silvius J. An Ecological Approach to Reducing Potentially Inappropriate Medication Use: Canadian Deprescribing Network. Can J Aging. 2017 Mar;36(1):97-107. doi: 10.1017/S0714980816000702. Epub 2017 Jan 16.

  PMID: 28091333 BACKGROUND

• Rotermann M, Sanmartin C, Hennessy D, Arthur M. Prescription medication use by Canadians aged 6 to 79. Health Rep. 2014 Jun;25(6):3-9.

  PMID: 24941315 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

• Cadogan CA, Ryan C, Francis JJ, Gormley GJ, Passmore P, Kerse N, Hughes CM. Improving appropriate polypharmacy for older people in primary care: selecting components of an evidence-based intervention to target prescribing and dispensing. Implement Sci. 2015 Nov 16;10:161. doi: 10.1186/s13012-015-0349-3.

  PMID: 26573745 BACKGROUND

• Anthierens S, Tansens A, Petrovic M, Christiaens T. Qualitative insights into general practitioners views on polypharmacy. BMC Fam Pract. 2010 Sep 15;11:65. doi: 10.1186/1471-2296-11-65.

  PMID: 20840795 BACKGROUND

• Trenaman SC, Hill-Taylor BJ, Matheson KJ, Gardner DM, Sketris IS. Antipsychotic Drug Dispensations in Older Adults, Including Continuation After a Fall-Related Hospitalization: Identifying Adherence to Screening Tool of Older Persons' Potentially Inappropriate Prescriptions Criteria Using the Nova Scotia Seniors' Pharmacare Program and Canadian Institute for Health's Discharge Databases. Curr Ther Res Clin Exp. 2018 Aug 31;89:27-36. doi: 10.1016/j.curtheres.2018.08.002. eCollection 2018.

  PMID: 30294400 BACKGROUND

• Reeve E, Gnjidic D, Long J, Hilmer S. A systematic review of the emerging de fi nition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol. 2015 Dec;80(6):1254-68. doi: 10.1111/bcp.12732.

  PMID: 27006985 BACKGROUND

• Steinman MA. Polypharmacy-Time to Get Beyond Numbers. JAMA Intern Med. 2016 Apr;176(4):482-3. doi: 10.1001/jamainternmed.2015.8597. No abstract available.

  PMID: 26999383 BACKGROUND

• Johansson T, Abuzahra ME, Keller S, Mann E, Faller B, Sommerauer C, Hock J, Loffler C, Kochling A, Schuler J, Flamm M, Sonnichsen A. Impact of strategies to reduce polypharmacy on clinically relevant endpoints: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Aug;82(2):532-48. doi: 10.1111/bcp.12959. Epub 2016 May 7.

  PMID: 27059768 BACKGROUND

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MeSH Terms

Conditions

Frailty

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Shanna Trennaman

  Dalhousie University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group study using a pre-, post-analysis. We will examine medication use, medication appropriateness, quality of life, and satisfaction with the intervention for participants before and after our deprescribing intervention.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 4, 2019
• Study Start: April 26, 2019
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)