Theoretical Underpinnings of a Model to Reduce Polypharmacy and Its Negative Health Effects: Introducing the Team Approach to Polypharmacy Evaluation and Reduction (TAPER).

BACKGROUND: Polypharmacy, particularly among older adults, is gaining recognition as an important risk to health. The harmful effects on health arise from disease-drug and drug-drug interactions, the cumulative burden of side effects from multiple medications and the burden to the patient. Single-disease clinical guidelines fail to consider the complex reality of optimising treatments for patients with multiple morbidities and medications. Efforts have been made to develop and implement interventions to reduce the risk of harmful effects, with some promising results. However, the theoretical basis (or pre-clinical work) that informed the development of these efforts, although likely undertaken, is unclear, difficult to find or inadequately described in publications. It is critical in interpreting effects and achieving effectiveness to understand the theoretical basis for such interventions. OBJECTIVE: Our objective is to outline the theoretical underpinnings of the development of a new polypharmacy intervention: the Team Approach to Polypharmacy Evaluation and Reduction (TAPER). METHODS: We examined deprescribing barriers at patient, provider, and system levels and mapped them to the chronic care model to understand the behavioural change requirements for a model to address polypharmacy. RESULTS: Using the chronic care model framework for understanding the barriers, we developed a model for addressing polypharmacy. CONCLUSIONS: We discuss how TAPER maps to address the specific patient-level, provider-level, and system-level barriers to deprescribing and aligns with three commonly used models and frameworks in medicine (the chronic care model, minimally disruptive medicine, the cumulative complexity model). We also describe how TAPER maps onto primary care principles, ultimately providing a description of the development of TAPER and a conceptualisation of the potential mechanisms by which TAPER reduces polypharmacy and its associated harms.

Linking Patients' Goals and Priorities to Recommendations for Medication Changes in a Polypharmacy-Focused Structured Clinical Pathway.

Polypharmacy is associated with poorer health outcomes in older adults. It is challenging to minimize the harmful effects of medications while maximizing benefits of single-disease-focused recommendations. Integrating patient input can balance these factors. The objectives are to describe the goals, priorities, and preferences of participants asked about these in a structured process to polypharmacy, and to describe the extent that decision-making within the process mapped onto these, signaling a patient-centered approach. This is a single-group quasi-experimental study, nested within a feasibility randomized controlled trial. Patient goals and priorities were mapped to medication recommendations made during the intervention. Overall, there were 33 participants who reported 55 functional goals and 66 symptom priorities, and 16 participants reported unwanted medications. Overall, 154 recommendations for medication alterations occurred. Of those, 68 (44%) recommendations mapped to the individual's goals and priorities, whereas the rest were based on clinical judgment where no priorities were expressed. Our results signal this process supports a patient-centered approach: allowing conversations around goals and priorities in a structured process to polypharmacy should be integrated into subsequent medication decisions.

Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy.

BACKGROUND: Polypharmacy is associated with poorer health outcomes in older adults. Other than the associated multimorbidity, factors contributing to this association could include medication adverse effects and interactions, difficulties in managing complicated medication regimes, and reduced medication adherence. It is unknown how reversible these negative associations may be if polypharmacy is reduced. The purpose of this study was to determine the feasibility of implementing an operationalized clinical pathway aimed to reduce polypharmacy in primary care and to pilot measurement tools suitable for assessing change in health outcomes in a larger randomized controlled trial (RCT). METHODS: We randomized consenting patients ≥ 70 years old on ≥ 5 long-term medications into intervention or control groups. We collected baseline demographic information and research outcome measures at baseline and 6 months. We assessed four categories of feasibility outcomes: process, resource, management, and scientific. The intervention group received TAPER (team approach to polypharmacy evaluation and reduction), a clinical pathway for reducing polypharmacy using "pause and monitor" drug holiday approach. TAPER integrates patients' goals, priorities, and preferences with an evidence-based "machine screen" to identify potentially problematic medications and support a tapering and monitoring process, all supported by a web-based system, TaperMD. Patients met with a clinical pharmacist and then with their family physician to finalize a plan for optimization of medications using TaperMD. The control group received usual care and were offered TAPER after follow-up at 6 months. RESULTS: All 9 criteria for feasibility were met across the 4 feasibility outcome domains. Of 85 patients screened for eligibility, 39 eligible patients were recruited and randomized; two were excluded post hoc for not meeting the age requirement. Withdrawals (2) and losses to follow-up (3) were small and evenly distributed between arms. Areas for intervention and research process improvement were identified. In general, outcome measures performed well and appeared suitable for assessing change in a larger RCT. CONCLUSIONS: Results from this feasibility study indicate that TAPER as a clinical pathway is feasible to implement in a primary care team setting and in an RCT research framework. Outcome trends suggest effectiveness. A large-scale RCT will be conducted to investigate the effectiveness of TAPER on reducing polypharmacy and improving health outcomes. TRIAL REGISTRATION: clinicaltrials.gov NCT02562352 , Registered September 29, 2015.

Interventions to address polypharmacy in older adults living with multimorbidity: Review of reviews.

OBJECTIVE: To summarize evidence from published systematic reviews evaluating the effect of polypharmacy interventions on clinical and intermediate outcomes. It also summarizes the adverse events that may occur as a result of these interventions. DATA SOURCES: A literature search was conducted using the electronic databases MEDLINE, Embase, CINAHL, Cochrane Central, and Cochrane Database of Systematic Reviews (PROSPERO registration number: CRD42018085767). STUDY SELECTION: The search yielded a total of 21,329 citations, of which 619 were reviewed as full text and 5 met the selection criteria. SYNTHESIS: The polypharmacy interventions were found to produce statistically significant reductions in potentially inappropriate prescribing and improved medication adherence; however, the observed effects on clinical and intermediate outcomes were inconsistent. None of the included reviews reported any significant benefit of polypharmacy interventions for quality-of-life outcomes. Specific to health care utilization and cost, polypharmacy interventions reduced health care resource usage and expenditure. The reviews reported no differences in adverse drug events between polypharmacy interventions and usual care groups. The overall certainty of evidence was reported as low to very low across included reviews. CONCLUSION: Polypharmacy interventions are associated with reductions in potentially inappropriate prescribing and improvements in medication adherence. However, there is limited evidence of their effectiveness for clinical and intermediate outcomes.

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.

Polypharmacy and mobility outcomes.

Polypharmacy is known to be associated with negative consequences of mobility related conditions such as falls, functional decline and disability. This systematic review highlights the effectiveness of deprescribing interventions on mobility related conditions in older adults in the community dwelling reported taking five or more medications daily.

'I think this medicine actually killed my wife': patient and family perspectives on shared decision-making to optimize medications and safety.

BACKGROUND: This study explored the perspectives and experiences from patients and families around how patient/family preferences and priorities are considered in medication-related discussions and decisions within the healthcare system. METHODS: We conducted a qualitative study using focus groups with residents of Southern Ontario and British Columbia (N = 16). Three focus groups were conducted using a semi-structured focus group guide. The audiotaped focus group discussions were transcribed verbatim. A thematic analysis, using inductive coding, was completed. RESULTS: A total of three main themes [and several sub-themes (and sub-sub-themes)] emerged from the data: patient and family expertise [lived experience, information expert, and perceived expert roles (patient/family, healthcare provider)], perceived patient-centredness (relationship qualities of healthcare provider and assumptions about patients), and system (time, coordination and communication, and culture). Stories told by participants helped to clarify the relationships between the themes and sub-themes, leading to, what we understand as shared decision-making around medications and subsequent health outcomes. CONCLUSIONS: Our findings showed that shared decision-making resulted from both recognition and integration of the personal expertise of the patient and family in medications, and perceived patient-centredness. This is broadly consistent with the current conceptualization of evidence-based medicine. The stories told highlight the complex, dynamic, and nonlinear nature of shared decision-making for medications, and that patient priorities are not as integrated into shared decision-making about medications as we would hope. This suggests the need for developing a systematic process to elicit, record, and integrate patient preferences and priorities about medications to create space for a more patient-centred conversation.

Self-efficacy for medication management: a systematic review of instruments.

BACKGROUND: Medication self-efficacy is a potentially important construct in research around optimal use of prescription medications. A number of medication self-efficacy measures are available; however, there is no systematic review of existing instruments and cataloguing of their theoretical underpinnings or psychometric properties, strengths, and weaknesses. The aim of the study was to identify instruments that measure self-efficacy for medication management. The study also aimed to examine the quality, theoretical grounding, and psychometric evaluation of existing measures of self-efficacy for medication management. The study was a systematic review. METHODS: Data were extracted from PubMed, OVID, and MEDLINE using a predefined search strategy. Citations were included if they reported the development and/or psychometric evaluation of an instrument to measure self-efficacy for medication management and were in English. Abstracts were screened for studies potentially meeting eligibility criteria. Full articles of these studies were then reviewed in depth. The review was carried out independently by two members of the research team. RESULTS: The search identified 158 citations of which 12 were included after screening. Full review identified 3 articles fitting inclusion criteria for the review. Generally, development was theoretically grounded and included patients and experts in the field. Psychometric testing showed evidence of internal consistency (2/3 instruments) and test-retest reliability (1/3 instruments). All instruments showed some validity; however, assessment of all forms of validity for each instrument was lacking. CONCLUSION: Although our analysis would recommend the use of the Self-Efficacy for Appropriate Medication Use Scale because of the current evidence of validity and reliability, more psychometric evaluation is required, particularly in terms of responsiveness to change as self-efficacy is a malleable patient-level factor. Three measures of self-efficacy for medication management were identified. Overall, some evidence of reliability and/or validity was demonstrated for all instruments; however, other forms of validity were not tested (ie, responsiveness to change). Use of a well-validated measure of self-efficacy medication management is essential in order to understand relationships between medication self-efficacy and other patient-reported outcomes such as patient-centeredness, patient enablement, and burden of treatment, an important area of research that is currently lacking.