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

Cette thèse teste l’hypothèse selon laquelle l’initiation du processus de déprescription des benzodiazépines peut être facilité chez les aînés via l’utilisation de documents éducatifs fondés sur des données probantes, soulignant les risques associés à ces médicaments ainsi que les alternatives non pharmacologiques plus sécuritaires. Cette thèse détaille comment nous avons développé, testé et adapté des outils éducatifs destinés aux consommateurs de benzodiazépines en nous basant sur des éléments de la théorie sociale cognitive et de la théorie constructiviste de l'apprentissage. Notre recherche a révélé l’importance du soutien offert par les professionnels de la santé chez les patients intéressés à déprescrire. Les étapes subséquentes de notre programme de recherche visaient à fournir aux aînés l'information nécessaire pour initier la conversation sur la déprescription, et, de façon simultanée, améliorer le niveau de confiance et outiller les professionnel de la santé, pour leur permettre d’assister les patients motivés à arrêter leurs sédatif-hypnotiques. Nous avons d'abord mené l'essai randomisé par grappes EMPOWER, où nous avons recruté 303 usagers chroniques de benzodiazépines âgés de 65 à 95 ans, dans 30 pharmacies communautaires (15 interventions, n = 148 participants, 15 témoins, n = 155). Une analyse préliminaire de l'effet de l'intervention sur la perception du risque associé aux benzodiazépines chez les participants a révélé que 45,1% de ceux ayant reçu l'intervention EMPOWER avaient signalé une augmentation du risque perçu, ce qui est associé à une meilleure acquisition des connaissances, à un changement des croyances, à une dissonance cognitive, à un sentiment d’auto-efficacité accru et à une plus grande intention d’entamer la conversation sur la cessation du médicament. Après 6 mois, 27% des patients du groupe d'intervention avaient cessé leur benzodiazépine contre 5% des témoins (différence de risque 23%, IC 95% 14-32%, ICC 0,008, NNT = 4). Aucun facteur de risque n’influençait l'effet de l'intervention. Subséquemment, nous avons cherché à mieux comprendre les raisons pour lesquelles l'intervention avait échoué ou réussi chez certains participants, afin de guider la recherche future. Nous avons vérifié si les patients avec un déficit cognitif léger avaient autant bénéficié de l'intervention que les patients avec une cognition normale. Une analyse post hoc de tous les participants ayant complété l'étude EMPOWER (n = i 261) n'a révélé aucune différence significative, l'arrêt des benzodiazépines ayant été noté chez 39 (32,0% [24.4,40.7]) participants avec déficit cognitif léger et chez 53 (38,1% [30.5,46.4]) participants avec une cognition normale (OR ajusté 0,79, IC 95% [0.45-1.38]). Nous avons ensuite mené une évaluation réaliste qui a révélé que l’intervention avait réussi à motiver 167 participants (n = 64%) à déprescrire, cela ayant été démontré par l'amélioration du niveau de connaissances et un sentiment d’inquiétude accru quant à la prise de benzodiazépines. La déprescription était plus souvent vouée à l’échec chez les participants s’il y avait un manque de support offert par un professionnel de la santé, si l’accent était mis sur la qualité de vie à court terme, ou en présence d’intolérance aux symptômes de sevrage ou de perception défavorable de son niveau de santé. En se basant sur les défis observés dans l'essai EMPOWER, nous avons cherché à éliminer certains des obstacles à la déprescription de sédatif-hypnotiques, ciblant spécifiquement la réticence des professionnels de la santé à soutenir les patients dans le processus de déprescription. L'intervention dans l'essai D-PRESCRIBE consistait en une approche éducative en deux volets dirigés par le pharmacien auprès des patients et des médecins, via la distribution de la brochure EMPOWER aux patients et d'une opinion pharmaceutique destinée aux prescripteurs. Nous avons développé un modèle standard d’opinion pharmaceutique fondé sur des données probantes, testé auprès d’un échantillon de 32 médecins et de 61 pharmaciens. Via révision du prototype, un modèle final a été obtenu par consensus. Dans le cadre de l'étude randomisée par grappes D-PRESCRIBE, nous avons recruté 299 utilisateurs chroniques de sédatif-hypnotiques âgés de 66 à 96 ans, provenant de 68 pharmacies communautaires (34 interventions, n = 145 participants, 34 témoins, n = 154). Après 6 mois, 44% des patients du groupe d'intervention avaient cessé leur sédatif-hypnotique, contre 6,5% chez les contrôles (différence de risque 38%, IC 95% 24-48%, ICC 0,012, NNT = 3). Les taux de cessation de D-PRESCRIBE étaient significativement plus élevés que ceux observés dans l'étude EMPOWER. Les résultats suggèrent que l’ajout d’une composante éducative chez les prescripteurs réduit leur réticence à soutenir un patient motivé par le processus de déprescription. 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: Benzodiazépine, Personnes âgées, Pharmacie communautaire, Études randomisée par grappes, Éducation du patient, Soins axés sur le patient, Ordonnances potentiellement non-appropriées, Pratique collaborative, Benzodiazepine, Older adults, Community pharmacies, Clusterrandomized trial, Patient education, Patient-centered care, Collaborative practice, Inappropriate medications