Structured Polypharmacy Management Before Elective Non-cardiac Surgery in Frail and Elderly People

NCT03445767 | Withdrawn

• 1 other identifier: 20170663
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polypharmacy

Keywords

Peri-operative care; Medication management

Outcome Measures

Primary Outcomes (1)

• Average number of PIMs

  Average number of Potentially Inappropriate Medications based on patient report

  90-days post-surgery

Secondary Outcomes (8)

• Patient-reported health outcomes: Health related quality of life

  Before surgery, 30-day post-surgery, and 90-day post-surgery

• Patient-reported health outcomes: Sleep Quality

  Before surgery, 30-days post-surgery, and 90-days post-surgery

• Patient-reported health outcomes: Disability

  Before surgery, 30-days post-surgery, and 90-days post-surgery

• Adverse Events

  Through study completion, an average of 7 days

• Hospital length of stay

  Within 365 days after surgery

Other Outcomes (4)

• Feasibility outcomes: Recruitment rate

  Through study completion, an average of 1 year

• Feasibility outcomes: Retention Rate

  Through study completion, an average of 1 year

• Acceptability of the intervention to patients

  Through study completion, an average of 1 year

Study Arms (2)

Standard Care

NO INTERVENTION

All patients will receive perioperative care per the standards of TOH. Standard care relevant to our study consists of a history by a nurse or physician; a best possible medication history performed by a pharmacy technician; and standardized perioperative-specific medication recommendations (e.g., anticoagulant, diabetes agent, and ACE-inhibitor management) based on medical directives. Medication recommendations beyond these medical directives do not occur as standard care in our clinics. Participants will be informed that their medical care will proceed as usual and that they are being recruited for a study to evaluate medication recommendations before surgery

Intervention

EXPERIMENTAL

In addition to standard care, the intervention will include a structured preoperative polypharmacy management strategy that consists of: a) input of best possible medication history and comorbidities into our polypharmacy management tool (MedSafer); b) communication of the prioritized deprescribing plan (if indicated) to the patient's active treating physicians (automatically via fax), to the perioperative team (surgeon, anesthesiologist), and to the electronic medical record. During the pre-operative visit, the patient will receive a generalized information flyer about deprescribing. As in the usual care phase, patients will continue to receive usual recommendations from the perioperative team based on medical directives relevant to the perioperative period.

Other: MedSafer

Interventions

MedSafer OTHER

An electronic deprescribing intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation. These recommendations are presented to the treating physicians for their consideration.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 26, 2018
• Study Start: February 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share