Clinical trial NCT03445767: Structured Polypharmacy Management Before Elective Non-cardiac Surgery in Frail and Elderly People
Official title: Structured Polypharmacy Management Before Elective Non-cardiac Surgery in Frail and Elderly People: a Pilot for a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Polypharmacy
Keywords: Peri-operative care
Medication management
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The older segment of the population is growing faster than any other segment. Older people have surgery more often than any other age group, and these older patients often take multiple medications, including medications that may result in more side effects (and risk) than benefit. Older patients who take multiple medications, and especially high risk medication, are more likely to die after surgery, and in those who survive, levels of disability are higher. For these reasons, testing a program that reviews the medications of older patients before surgery to decrease the use of dangerous medicines is very important.

Most older patients in Ontario are seen in a preoperative anesthesiology clinic. Previous research has shown that this clinic visit is a "teachable moment", where patients are more motivated to change their health-related behaviors. Therefore, the investigators propose to compare a structured medication review in the preoperative clinic to the usual care that people receive with the goal of decreasing the number and potential danger of the medications taken by older surgical patients. Recent systematic reviews have shown that no such programs have been tested to date in patients having surgery, so our findings will be unique. In addition, the investigators will also measure the impact of this program on people's health status, disability status, and use of healthcare resources (such as days in hospital) after surgery. If the investigators find that this single-center pilot randomized controlled designed study positively impacts these patient health outcomes, the investigators will perform a future multi-center cluster randomized trial of our intervention.

MedSafer is a CIHR-funded Canadian software product that aids patients and physicians in deprescribing. It contains rules that identify potentially inappropriate medications (PIMs), prioritizes them in terms of risk of harm, and provides deprescribing opportunities for safely stopping medications using the current evidence as well as incorporating patient comorbidities in the analyses.

Detailed description: The population is aging rapidly, and elderly people have surgery at a higher rate than any other age group. Advanced age is independently associated with a 2- to 4-fold increase in adverse event rates after surgery, as well as increased rates of postoperative healthcare resource use such as costs and prolonged hospital length of stay. Polypharmacy (defined by the World Health Organization as taking \>5 medications concurrently), and potentially inappropriate medications (PIM; i.e., taking medications that are likely to produce more harm than benefit given an individual's risk profile) are increasingly common in older people.

In the perioperative setting, the epidemiology of polypharmacy and inappropriate prescribing is poorly described. Single center studies of general surgery patients suggest that inappropriate prescriptions are independently associated with a 3- to 4- fold increase in the odds of serious complications, while hip fracture patients with polypharmacy have an increased risk of readmission and are often discharged on the same PIMs which may have caused the fracture.

Strategies to address polypharmacy and medication appropriateness have been synthesized in two recent systematic reviews. In general, interventions resulted in decreases in the number of medications taken, and overall medication appropriateness. However, substantial gaps in this knowledge base were also identified. First, no perioperative interventions were identified. Second, overall methodological quality of identified studies was low to very low, with significant issues identified related to study design and inadequate power, poor allocation concealment, and lack of appropriate analytic techniques. Finally, although decreasing the number and inappropriateness of medications are worthwhile outcomes, most studies did not report the impact of these interventions on patient-centered or system-level outcomes.

The preoperative anesthesiology clinic encounter may represent an optimal time to initiate polypharmacy management strategies, as the surgical encounter with the healthcare team is a teachable moment where patients demonstrate extra motivation to make positive changes in their health behaviors. Therefore, the hypothesized positive impact of preoperative polypharmacy management could extend not only into the postoperative period, but also on a longitudinal basis beyond the transition from acute postoperative care.

The preoperative polypharmacy management intervention will be based on a pragmatic, evidence-based, CIHR-funded tool developed by our coinvestigators from McGill for use in elderly inpatients. It has recently been field tested in a 600-patient inpatient study at the Universities of Ottawa, Toronto, and McGill. The tool is a web-based platform developed by experts in internal and geriatric medicine and is based on best-practice guidelines, Choosing Wisely Canada's declarative statements, and evolving issues (such as narcotic and benzodiazepine co-administration). It contains rules that identify PIMs, prioritizes them in terms of risk of harm, and provides deprescribing opportunities for safely stopping medications using the current evidence as well as incorporating patient comorbidities in the analyses.

The investigators will address a clear knowledge gap in the literature by conducting a single center pilot randomized trial to evaluate the efficacy of a structured polypharmacy management program in preparation for a future multicenter randomized trial. The primary objectives of this pilot study are to: (1) provide evidence of efficacy of the intervention in reducing PIMs, (2) estimate characteristics of secondary outcomes, specifically patient-centered and system-level measures, including baseline prevalence and measures of variation, to inform sample size calculations for a future multi-site randomized trial powered to meaningfully impact these outcomes, and (3) demonstrate acceptability of the intervention to patients and providers along with potential barriers and facilitators to implementation.

Eligibility criteria: Inclusion Criteria:

* English or French-speaking people aged 65 years or older seen in the Pre-Admission Unit prior to elective, inpatient non-cardiac surgery

Exclusion Criteria:

* Patients who cannot be reached by telephone for follow up, or are not covered by the Ontario Health Insurance

Primary outcomes:
measure: Average number of PIMs
timeFrame: 90-days post-surgery
Secondary outcomes:
measure: Patient-reported health outcomes: Health related quality of life
timeFrame: Before surgery, 30-day post-surgery, and 90-day post-surgery
measure: Patient-reported health outcomes: Sleep Quality
timeFrame: Before surgery, 30-days post-surgery, and 90-days post-surgery
measure: Patient-reported health outcomes: Disability
timeFrame: Before surgery, 30-days post-surgery, and 90-days post-surgery
measure: Adverse Events
timeFrame: Through study completion, an average of 7 days
measure: Hospital length of stay
timeFrame: Within 365 days after surgery
measure: Proportion of patients discharged to an institution, readmissions within 30 days of discharge
timeFrame: Within 365 days after surgery
measure: Patient safety indicators
timeFrame: Within 365 days after surgery
measure: Costs of hospitalization
timeFrame: Within 365 days after surgery
Other outcomes:
measure: Feasibility outcomes: Recruitment rate
timeFrame: Through study completion, an average of 1 year
measure: Feasibility outcomes: Retention Rate
timeFrame: Through study completion, an average of 1 year
measure: Acceptability of the intervention to patients
timeFrame: Through study completion, an average of 1 year
measure: Acceptability of the intervention to providers
timeFrame: Through study completion, an average of 1 year
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