Clinical trial NCT03903484: Deprescribing in Primary Health Care
Official title: A Collaborative Intervention for Streamlining Medication Appropriateness and Deprescribing Within Integrated Health-Care Teams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inappropriate Prescribing
Primary Health Care
Polypharmacy
Keywords: Frailty
Deprescribing
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: Canadian Frailty Network
name: Horizon Health Network
First posted: 2019-04-04
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in patient's medication appropriateness
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: Healthcare professionals' experience with a collaborative deprescribing intervention
timeFrame: At the end of study (approximately 6 months after the start)
measure: Change in patient quality of life after deprescribing intervention
timeFrame: Before and after deprescribing intervention (separated 6 months)
measure: Patient experience with a collaborative deprescribing intervention
timeFrame: Before and after deprescribing intervention (separated 6 months)
Secondary outcomes:
measure: Change in number of medications
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: Change in number of medication administration times per day
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: Change in the number of medications used on the anticholinergic cognitive burden scale
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: Change in the number of medications used that are targeted for discontinuation in the intervention
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: The number of drugs discontinued
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: The number of drugs with doses decreased
timeFrame: Before and after deprescribing intervention (separated 6 months)
measure: Decrease in polypharmacy
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: Change in medication cost
timeFrame: Before and after deprescribing intervention (counts separated 6 months)
measure: Change in health care utilization
timeFrame: Comparison of the same 6 month period in the preceding year to the 6 month period of the deprescribing intervention
measure: Change in health care utilization
timeFrame: Comparison of the same 6 month period in the preceding year to the 6 month period of the deprescribing intervention
measure: Withdrawal reactions as result of deprescribing intervention
timeFrame: During deprescribing intervention (6 months in duration)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia (NS)
Study officials:
affiliation: Dalhousie University
name: Shanna Trennaman
role: STUDY_DIRECTOR
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