Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial

Background Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient’s priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults. Methods We designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months. Discussion Our trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient’s goals and priorities for treatment. Trial registration Clinical Trials.gov NCT02942927. First registered on October 24, 2016. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05685-9.


Measure
Measure description Validity and reliability information different health professionals, having to rely on help from family and friends). The scale used to rate their difficulty is from "not difficult" to "extremely difficult". Quality of life EuroQol five dimension (EQ5D-5L) [3] Respondents rate 5 domains of health (mobility, self-care, usual activities, pain/discomfort and finally anxiety/depression) on a 5-point scale. Scores range from 0 to 1, with higher scores representing higher quality of life [3,4]. In addition, a single-item assesses respondents' overall level of health state from 0-100 ('worst imaginable health' to 'best imaginable health').
It is suitable for cost utility analysis and will be used in our economic analysis [3].
Short Form Health Survey (SF36v2) [7] Eight domains, including role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, physical functioning and mental health are rated. Scores range from a scale of 0-100, with higher values representing higher quality of life for the domain.
The SF-36 is considered a valid, reliable, and concise generic measure of health [8].

Cognition
Mini Mental Status Examination [9] The examination consists of 11 items that aim to measure five areas of cognitive functions: orientation, registration, attention, calculation, recall and language. Scores of each item summed, scores range It has also been used to show change in studies of discontinuation of antipsychotic medication in older adults [10,11].

Measure
Measure description Validity and reliability information from 0 to 30 [9]. Scores of 0-9, 10-19, 20-25, 26-30 represent different degrees of impairment, including severe, moderate, mild, and potentially normal, respectively Fatigue Avlund mobility-tiredness subscale [12] This is a 6-item subscale that asks participants about fatigue with performing six activities [12]. The scoring system is based on a yes (1) and no (0) answers, which are added for a sum (0-6 points).
Higher values indicate a greater degree of fatigue.
The scale has been validated and used with younger-older populations and has shown good reliability, validity, and predictive value [13,14].
Nutritional status Mini Nutritional Assessment Short-Form [15,16] The survey has 6 items, with each having a score that are summed together. The scores range from 0-14, with higher scores indicating a better nutritional status.
The scale has been shown to be a well validated tool for nutritional assessment in older populations and is suitable for use in ambulatory populations [15,16] and frail older adults [16]. Physical function capacity and ability Mänty structured interview [17] Responses define preclinical, minor or major mobility limitation as well as no mobility limitation for three common tasks (walking 2 km, walking 0.5 km and climbing 1 flight of stairs).
The survey is a valid measure to capture the early signs of disability and identify those at high risk for future disability [17].
Timed up and go [18] Participants are instructed to sit in a chair, and on the word 'go', stand up from the chair and walk at a safe and comfortable pace to a mark on the floor (3m away), turn around, then return to the chair and sit down This test is a valid and reliable measure of lower body strength and function as well as balance, with normative reference values stratified by age [18,19].

Measure
Measure description Validity and reliability information Grip strength [20] Grip strength will be measured using a JAMAR hand dynamometer. A protocol involving forearm supported grip strength based on [21], but alternating between right and left hands to prevent fatigue will be used as a measure of grip strength. The mean of three trials of each hand will be used in data analyses.
Grip strength measures have excellent test-retest reliability and normative distributions have been developed, stratified by age and sex [20][21][22].
Global rating of change for balance [23] Participants are asked to assess their current balance ability compared to their status at a previous time point (6-months previous), and then indicate the difference on a visual analogue scale from -5 ('very much worse') to 5 ('very much better'), with a midpoint of 0 ('unchanged').
Global ratings of change have been used to measure patient-detected change on a wide variety of constructs, showing high test-retest reliability and face-validity [23].

Falls
Not applicable Number of significant falls (defined as falls resulting in medical consultation or treatment) will be self-reported.

Not applicable
Pain Brief Pain Inventory [24] Only those items contributing to the scores of the two subscales (pain interference and pain severity) will be used.
The Brief Pain Inventory has shown convergent validity and discriminative validity [25].

Sleep
Sleep item from the 15-D scale [26] 1 question rating sleep quality from "ability to sleep normally" to "severe problems with sleeping" The 15-D has been shown to be valid in a variety of population [26] including, chronic pain [27] and Parkinson's disease [28].

Patient enablement A modified version of the validated Patient Enablement Instrument
Consists of 6 questions that revolve around patient understanding of, and coping with, health issues as a result of a consultation The Patient Enablement Instrument has presented satisfactory measurement properties including

Measure
Measure description Validity and reliability information developed in primary care in the United Kingdom [29]. The stem "after a usual visit with your family doctor, do you feel that you are…" was used instead of "as a result of your visit to the doctor today…" with a healthcare provider. The total score would range from 0-12, with a higher score indicating a stronger patient enablement.
Medication selfefficacy Self-Efficacy for Appropriate Medication Use scale [31] Thirteen items are rated as "not confident", "somewhat confident" or "very confident". Means for two subscales, self-efficacy for taking medications under difficult circumstances and self-efficacy for continuing to take medications when circumstances surrounding medicationtaking are uncertain, will be calculated.
The measure has shown to be a reliable and valid instrument to measure self-efficacy in medication management and our own systematic review suggests is the highest quality measure of medication self-efficacy available at this time [32].

Healthcare utilization Not applicable
Hospital admissions, and emergency department/urgent care and primary care visits will be collected from patient electronic medical records or other administrative data Not applicable