Deprescribing in Primary Health Care

February 6, 2023 updated by: Nova Scotia Health Authority

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Deprescribing intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before and after deprescribing intervention (counts separated 6 months)
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.
At the end of study (approximately 6 months after the start)
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)
Before and after deprescribing intervention (separated 6 months)
Patient experience with a collaborative deprescribing intervention
Time Frame: Before and after deprescribing intervention (separated 6 months)
Qualitative post intervention survey
Before and after deprescribing intervention (separated 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of medications
Time Frame: Before and after deprescribing intervention (counts separated 6 months)
The number of medications being used before and after the deprescribing intervention
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)
The number of times medication are administered in a day before and after the deprescribing intervention
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)
The number of medications used on the anticholinergic cognitive burden scale before and after the deprescribing intervention
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 targeted medications used before and after the deprescribing intervention
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)
Change in the number of drugs used before and after deprescribing intervention
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)
Change in number of drugs with dose decreased that were not discontinued
Before and after deprescribing intervention (separated 6 months)
Decrease in polypharmacy
Time Frame: Before and after deprescribing intervention (counts separated 6 months)
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
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 medication cost before and after deprescribing intervention
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
Number of unplanned hospitalizations
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
Number of emergency department visits
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)
Withdrawal symptoms are discussed at every visit with a healthcare professional and are identified using a general scale (mild, moderate, severe).
During deprescribing intervention (6 months in duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University
Horizon Health Network
Canadian Frailty Network

Investigators

  • Study Director: Shanna Trennaman, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 26, 2019

Primary Completion (ACTUAL)

June 8, 2022

Study Completion (ACTUAL)

June 8, 2022

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1024257
  • CAT2017-10 (OTHER_GRANT: Canadian Frailty Network)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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