Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deprescribing in Primary Health Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903484
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Dalhousie University
Canadian Frailty Network
Horizon Health Network
Information provided by (Responsible Party):
Melissa Andrew, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Inappropriate Prescribing Primary Health Care Polypharmacy Other: Deprescribing toolbox and intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Collaborative Intervention for Streamlining Medication Appropriateness and Deprescribing Within Integrated Health-Care Teams
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. Patient experience with a collaborative deprescribing intervention [ Time Frame: Before and after deprescribing intervention (separated 6 months) ]
    Qualitative post intervention survey


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Change in medication cost [ Time Frame: Before and after deprescribing intervention (counts separated 6 months) ]
    Change in medication cost before and after deprescribing intervention

  9. 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

  10. 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

  11. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903484


Contacts
Layout table for location contacts
Contact: Leah Bennett 9024735607 leahbennett@nshealth.ca
Contact: Shanna Trenaman shanna.trenaman@dal.ca

Sponsors and Collaborators
Melissa Andrew
Dalhousie University
Canadian Frailty Network
Horizon Health Network
Investigators
Layout table for investigator information
Study Director: Shanna Trennaman Dalhousie University
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Melissa Andrew, PI, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03903484    
Other Study ID Numbers: 1024257
CAT2017-10 ( Other Grant/Funding Number: Canadian Frailty Network )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa Andrew, Nova Scotia Health Authority:
Frailty
Deprescribing