Inappropriate PrescribingNCT03903484
Deprescribing in Primary Health Care
A study testing Deprescribing toolbox and intervention in people with Inappropriate Prescribing and Primary Health Care, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inappropriate Prescribing, Primary Health Care, Polypharmacy
- What is being tested?
- Deprescribing toolbox and intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2019to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Collaborative Intervention for Streamlining Medication Appropriateness and Deprescribing Within Integrated Health-Care Teams
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.
Read the detailed description
As frailty and medical comorbidity increases, the number of medications used increases. The resultant polypharmacy is intended to improve the health status; however, large observational studies refute this premise. In fact, polypharmacy (more than 3 medications) is associated with increased hospitalization (OR 3.79, 95% CI {1.33, 10.90}) and increased mortality (OR 1.27, 95% CI {1.04, 1.56}). With increasing polypharmacy, the risk of adverse health outcomes increases so it is important that deprescribing initiatives are promoted to reduce medication use to improve patient outcomes.
Numerous tools exist that can be used to identify Potentially Inappropriate Medications (PIM), including; Beer's list, STOPP/START, PRISCUS, LAROCHE, Medication Appropriateness Index (MAI), Drug Burden Index, Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale, and numerous deprescribing tools from the Canadian Deprescribing Network. The implementation of these tools is not as high as it could or should be, as evidenced by polypharmacy data, such as the 2011 study that found 30% of Canadian seniors aged 65 to 79 took at least five prescription medications concurrently. It is likely that medication use is greater among the oldest old.
The literature is replete with evidence and tools to identify the medications that are the most likely to cause adverse events, however this information is not being translated into practice as medication use and PIM use persists in older adults. Deprescribing is the process of withdrawal of an inappropriate medication supervised by a healthcare professional with the goal of managing polypharmacy and improving outcomes. Healthcare practitioners self-identify that deprescribing is a challenging process. Primary care physicians have increasingly complex patient loads, which contributes to increased numbers of specialist involvement. This makes it challenging to know which medications are necessary and which can be discontinued and whose responsibility it is to initiate and monitor the deprescribing process. In Nova Scotia media has brought attention to PIM use with our high rates of benzodiazepine use. Recent publications have also identified high use of antipsychotics in Nova Scotia.
Previous work suggests including a pharmacist or nurse in deprescribing helps with its success. Indeed, prior work suggests that culture change, and integrated primary care can make a small difference in polypharmacy, but that more targeted interventions with specific engagement of pharmacists is needed. Pharmacists have extensive training in medication use, effects, safety and toxicity. They can identify and resolve medication related issues. Pharmacists can carry out treatment plans in a collaborative environment working with prescribers to monitor medication adherence, effect, and toxicity. Meta-analysis has identified 13 pharmacist led interventions to reduce polypharmacy, which included nine in primary care and two in nursing homes.
Society has a need for improved uptake of deprescribing to support appropriate drug use by adults. The tools and resources available have not led to widespread uptake/implementation. To date deprescribing remains one of the many demands on primary care providers (Family Physicians/Nurse Practitioners). The investigators consider the skill set of pharmacists as ideal to support and monitor patients as they move through the deprescribing process. The investigators recognize that deprescribing cannot happen without extensive communication with primary care providers so that all members of the healthcare team are aware and engaged with the patient and their deprescribing. In considering this collaborative practice clinics with pharmacists embedded in the practice have been identified as sites where pharmacist led deprescribing can successfully support patients through the deprescribing process. This pharmacist led deprescribing process will conform to the standard of care using an evidence supported framework for a selected number of drugs and using recognized deprescribing algorithms and guidelines.
- Conditions
- Inappropriate Prescribing, Primary Health Care, Polypharmacy
- Being tested
- Deprescribing toolbox and intervention
- Keywords
- Frailty, Deprescribing
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprescribing toolbox and interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Deprescribing toolbox and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient's medication appropriateness
Change in medication appropriateness index before and after the deprescribing intervention
Measured: 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.
Measured: 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)
Measured: Before and after deprescribing intervention (separated 6 months)
Patient experience with a collaborative deprescribing intervention
Qualitative post intervention survey
Measured: Before and after deprescribing intervention (separated 6 months)
Secondary outcomes (11)
Change in number of medications
The number of medications being used before and after the deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
Change in number of medication administration times per day
The number of times medication are administered in a day before and after the deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
Change in the number of medications used on the anticholinergic cognitive burden scale
The number of medications used on the anticholinergic cognitive burden scale before and after the deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
Change in the number of medications used that are targeted for discontinuation in the intervention
The number of targeted medications used before and after the deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
The number of drugs discontinued
Change in the number of drugs used before and after deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
The number of drugs with doses decreased
Change in number of drugs with dose decreased that were not discontinued
Measured: Before and after deprescribing intervention (separated 6 months)
Decrease in polypharmacy
The number patient participants that were on 5 or more medications before the deprescribing intervention and were on less than 5 medications after the deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
Change in medication cost
Change in medication cost before and after deprescribing intervention
Measured: Before and after deprescribing intervention (counts separated 6 months)
Change in health care utilization
Number of unplanned hospitalizations
Measured: Comparison of the same 6 month period in the preceding year to the 6 month period of the deprescribing intervention
Change in health care utilization
Number of emergency department visits
Measured: Comparison of the same 6 month period in the preceding year to the 6 month period of the deprescribing intervention
Withdrawal reactions as result of deprescribing intervention
Withdrawal symptoms are discussed at every visit with a healthcare professional and are identified using a general scale (mild, moderate, severe).
Measured: During deprescribing intervention (6 months in duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start26 Apr 2019
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, Canadian Frailty Network, Horizon Health Network
- Responsible party
- Sponsor
- Investigators
- Shanna Trennaman, Study director, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903484
- Sponsor's protocol ID
- 1024257
- Other IDs
- CAT2017-10
- Status last verified
- Feb 2023
- First submitted
- 27 Mar 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25164413Andrew 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.
PubMed 28960614Fried 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.
PubMed 25516023Schottker 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.
PubMed 28540438Nossaman 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.
PubMed 28958648Fastbom 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.
PubMed 25673123By 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.
PubMed 26446832O'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.
PubMed 25324330Holt 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.
PubMed 20827352Laroche 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.
PubMed 17554532Hanlon 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.
PubMed 1474400Hilmer 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.
PubMed 17452540Carnahan 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.
PubMed 17101747Tannenbaum 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.
PubMed 28091333Rotermann M, Sanmartin C, Hennessy D, Arthur M. Prescription medication use by Canadians aged 6 to 79. Health Rep. 2014 Jun;25(6):3-9.
PubMed 24941315
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Intervention for Streamlining Medication Appropriateness and Deprescribing Within Integrated Health-Care Teams
- ClinicalTrials.gov ID
- NCT03903484
- Acronym / sponsor ID
- 1024257
- Conditions
- Inappropriate Prescribing, Primary Health Care, Polypharmacy
- Keywords
- Frailty, Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University, Canadian Frailty Network, Horizon Health Network
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As frailty and medical comorbidity increases, the number of medications used increases. The resultant polypharmacy is intended to improve the health status; however, large observational studies refute this premise. In fact, polypharmacy (more than 3 medications) is associated with increased hospitalization (OR 3.79, 95% CI {1.33, 10.90}) and increased mortality (OR 1.27, 95% CI {1.04, 1.56}). With increasing polypharmacy, the risk of adverse health outcomes increases so it is important that deprescribing initiatives are promoted to reduce medication use to improve patient outcomes.
Numerous tools exist that can be used to identify Potentially Inappropriate Medications (PIM), including; Beer's list, STOPP/START, PRISCUS, LAROCHE, Medication Appropriateness Index (MAI), Drug Burden Index, Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale, and numerous deprescribing tools from the Canadian Deprescribing Network. The implementation of these tools is not as high as it could or should be, as evidenced by polypharmacy data, such as the 2011 study that found 30% of Canadian seniors aged 65 to 79 took at least five prescription medications concurrently. It is likely that medication use is greater among the oldest old.
The literature is replete with evidence and tools to identify the medications that are the most likely to cause adverse events, however this information is not being translated into practice as medication use and PIM use persists in older adults. Deprescribing is the process of withdrawal of an inappropriate medication supervised by a healthcare professional with the goal of managing polypharmacy and improving outcomes. Healthcare practitioners self-identify that deprescribing is a challenging process. Primary care physicians have increasingly complex patient loads, which contributes to increased numbers of specialist involvement. This makes it challenging to know which medications are necessary and which can be discontinued and whose responsibility it is to initiate and monitor the deprescribing process. In Nova Scotia media has brought attention to PIM use with our high rates of benzodiazepine use. Recent publications have also identified high use of antipsychotics in Nova Scotia.
Previous work suggests including a pharmacist or nurse in deprescribing helps with its success. Indeed, prior work suggests that culture change, and integrated primary care can make a small difference in polypharmacy, but that more targeted interventions with specific engagement of pharmacists is needed. Pharmacists have extensive training in medication use, effects, safety and toxicity. They can identify and resolve medication related issues. Pharmacists can carry out treatment plans in a collaborative environment working with prescribers to monitor medication adherence, effect, and toxicity. Meta-analysis has identified 13 pharmacist led interventions to reduce polypharmacy, which included nine in primary care and two in nursing homes.
Society has a need for improved uptake of deprescribing to support appropriate drug use by adults. The tools and resources available have not led to widespread uptake/implementation. To date deprescribing remains one of the many demands on primary care providers (Family Physicians/Nurse Practitioners). The investigators consider the skill set of pharmacists as ideal to support and monitor patients as they move through the deprescribing process. The investigators recognize that deprescribing cannot happen without extensive communication with primary care providers so that all members of the healthcare team are aware and engaged with the patient and their deprescribing. In considering this collaborative practice clinics with pharmacists embedded in the practice have been identified as sites where pharmacist led deprescribing can successfully support patients through the deprescribing process. This pharmacist led deprescribing process will conform to the standard of care using an evidence supported framework for a selected number of drugs and using recognized deprescribing algorithms and guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Deprescribing intervention | Experimental | Other: Deprescribing toolbox and interventionIncluded 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deprescribing toolbox and interventionPharmacist-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. | Other | Deprescribing intervention |
Primary outcome
Change in patient's medication appropriateness
Time frame: Before and after deprescribing intervention (counts separated 6 months)
Change in medication appropriateness index before and after the deprescribing intervention
Healthcare professionals' experience with a collaborative deprescribing intervention
Time frame: At the end of study (approximately 6 months after the start)
Mixed methods (qualitative and quantitative) survey measuring satisfaction with deprescribing intervention using a five point Likert scale and open ended questioning.
Change in patient quality of life after deprescribing intervention
Time frame: Before and after deprescribing intervention (separated 6 months)
Quality of life survey using EuroQol - 5 Dimension (EQ-5D)
Patient experience with a collaborative deprescribing intervention
Time frame: Before and after deprescribing intervention (separated 6 months)
Qualitative post intervention survey
11 secondary outcomes
Change in number of medications
Time frame: Before and after deprescribing intervention (counts separated 6 months)
Change in number of medication administration times per day
Time frame: Before and after deprescribing intervention (counts separated 6 months)
Change in the number of medications used on the anticholinergic cognitive burden scale
Time frame: Before and after deprescribing intervention (counts separated 6 months)
Change in the number of medications used that are targeted for discontinuation in the intervention
Time frame: Before and after deprescribing intervention (counts separated 6 months)
The number of drugs discontinued
Time frame: Before and after deprescribing intervention (counts separated 6 months)
The number of drugs with doses decreased
Time frame: Before and after deprescribing intervention (separated 6 months)
Decrease in polypharmacy
Time frame: Before and after deprescribing intervention (counts separated 6 months)
Change in medication cost
Time frame: Before and after deprescribing intervention (counts separated 6 months)
Change in health care utilization
Time frame: Comparison of the same 6 month period in the preceding year to the 6 month period of the deprescribing intervention
Change in health care utilization
Time frame: Comparison of the same 6 month period in the preceding year to the 6 month period of the deprescribing intervention
Withdrawal reactions as result of deprescribing intervention
Time frame: During deprescribing intervention (6 months in duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 25164413Mannucci 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.
- Background: PubMed 28960614Andrew 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.
- Background: PubMed 25516023Fried 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.
- Background: PubMed 28540438Schottker 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.
- Background: PubMed 28958648Nossaman 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.
- Background: PubMed 25673123Fastbom 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.
- Background: PubMed 26446832By 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.
- Background: PubMed 25324330O'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.
- Background: PubMed 20827352Holt 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.
- Background: PubMed 17554532Laroche 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.
- Background: PubMed 1474400Hanlon 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.
- Background: PubMed 17452540Hilmer 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.
- The common pill that's killing in the shadow of the opioid crisisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanna Trennaman study director
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprescribing toolbox and intervention in people with Inappropriate Prescribing and Primary Health Care, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient's medication appropriateness (time frame: Before and after deprescribing intervention (counts separated 6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903484, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.