Evaluation of direct-to-patient educational approaches for reducing inappropriate sedative-hypnotic use in community-dwelling older adults

This thesis tests the hypothesis that older adults can enable the initiation of benzodiazepine deprescribing when equipped with evidence-based educational material about drug harms and safer non-pharmacological alternatives. The work described in this thesis explains how we developed, tested, refined and adapted educational tools for benzodiazepine consumers, based on elements of social cognitive theory and constructivist learning theory. Our research revealed that health care provider support is required to assist patients in following through on their initial desire to deprescribe. Subsequent steps in my research program aimed to simultaneously equip older adults with the information they need to drive deprescribing conversations, while also boosting health care provider support and self-efficacy for enabling motivated patients to successfully discontinue sedative-hypnotics. We first conducted the EMPOWER cluster randomized trial, where we recruited 303 chronic users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies (15 intervention, n=148 participants; 15 control, n= 155). A preliminary analysis was conducted to evaluate the intervention’s effect on participants risk perception about benzodiazepines through knowledge acquisition and change in beliefs. We showed that 45.1% of participants receiving the EMPOWER intervention reported an increased perceived risk, which was associated with better knowledge acquisition, change in beliefs, occurrence of cognitive dissonance, increased self- efficacy and increased intent to discuss discontinuation. Six-months outcomes from the trial revealed that 27% of the intervention group had discontinued benzodiazepine use compared to 5% of controls (risk difference 23%, 95% CI 14-32%, ICC 0.008, NNT=4) with no risk factor characteristics interacting with the effect of the intervention. We then aimed to gain a better understanding as to why the intervention failed or succeeded for certain participants in order to guide future research. We tested whether patients with mild cognitive impairment (MCI) received the same benefits from the intervention as patients with normal cognition. A post-hoc analysis of all participants iii completing the EMPOWER study (n=261) revealed no significant differences, with benzodiazepine discontinuation occurring in 39 (32.0% [24.4,40.7]) participants with MCI and in 53 (38.1% [30.5,46.4]) with normal cognition (aOR 0.79, 95% CI [0.45– 1.38]). We then conducted a realist evaluation, which showed that the intervention triggered the motivation to deprescribe among 167 (n=64%) participants, demonstrated by improved knowledge and increased concern about taking benzodiazepines. Contexts where the deprescribing mechanisms failed included lack of support from healthcare providers, short-term quality of life focus, intolerance to withdrawal symptoms and perceived poor health. Based on the challenges observed in the EMPOWER trial, we aimed to address some of the observed barriers to sedative-hypnotic deprescribing, specifically targeting healthcare provider reluctance to support patients in the deprescribing process. The intervention in the subsequent D-PRESCRIBE trial consisted of a two-pronged educational approach brokered by the pharmacist to patients and physicians, through distribution of the EMPOWER brochure to patients and a pharmaceutical opinion to prescribers. We developed a standardized template for an evidence-based pharmaceutical opinion, which we tested in a convenience sample of 32 primary care physicians and 61 primary care pharmacists. The content and format of the prototype underwent revisions until a consensus was reached on a final recommended template. We then conducted the D-PRESCRIBE cluster randomized trial, where we recruited 299 chronic sedative-hypnotic medication users aged 66-96 years, from 68 community pharmacies (34 intervention, n=145 participants; 34 control, n= 154). Six-months outcomes yielded a 44% discontinuation rate in the intervention group compared to a 6.5% rate in the controls (risk difference 38%, 95% CI 24-48%, ICC 0.012, NNT=3) with risk profile characteristics interacting with the effect of the intervention. Discontinuation rates in D-PRESCRIBE were significantly higher than those observed in the EMPOWER trial. Process outcomes from the trial suggest that the added value of adding an educational component to prescribers is that it decreases reluctance to support motivated patients to attempt and succeed at deprescribing.

Keyphrases: Pratique collaborative, Benzodiazepine, Older adults, Community pharmacies, Clusterrandomized trial, Patient education, Patient-centered care, Collaborative practice, Inappropriate medications