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Psychological and Clinical Factors That Predict Intent to Deprescribe Medications Among Older Adults

11 janvier 2022 mis à jour par: Vordenberg, University of Michigan
The investigators are conducting two experimental surveys to explore clinical and psychological factors that influence older adults' willingness to stop medications in the face of polypharmacy.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Around one-half of older adults take one or more medications that are inappropriate or medically unnecessary. These medications can cause side effects that are unacceptable to patients. Several studies provide guidance to clinicians about the process of stopping specific types of medications (e.g., steps that clinicians can take to reduce and stop a medication for anxiety or difficulty sleeping). However, these approaches are not always successful. A critical gap with these approaches is they tend to focus on the medication, rather than the patient, and their individual needs.

Our research team seeks to learn more about factors that are important to patients when they consider reducing or stopping a medication. The investigators will do this by conducting two surveys each with 4,800 older adults across four countries (United States, United Kingdom, Netherlands, and Australia). Each participant will be asked to give their opinions on a hypothetical patient scenario that has been developed by our diverse team in partnership with our stakeholder organizations. In the first survey, the investigators will examine how the reason for using the medication (e.g. preventing a disease or treating symptoms of a disease) as well as the reason for a recommendation to stop the medication (e.g. lack of benefit vs. potential for harm) influence older adults' willingness to stop medications. In the second survey, the investigators will examine how different social and clinical factors and whether the participant is making a recommendation about oneself (as if they were the patient in the case) or on behalf of the patient in the case (e.g., if it was their friend) influence their willingness to stop medications. The investigators will work with Qualtrics, an international company that distributes surveys, to collect this data that does not include any identifying information.

The investigators anticipate that once the survey is designed and show that it is successful for studying patient perspectives about stopping medicines, it can then apply the same study approach to test the effect of other relevant factor that may influence the decision to stop or reduce a medication. The investigators anticipate that our research will significantly contribute to our understanding of how older adults make decisions about stopping medications. This information will be helpful to researchers and clinicians to ensure future services can be developed to best support patients to make decisions about stopping or reducing inappropriate or unnecessary medication.

Type d'étude

Observationnel

Inscription (Réel)

10184

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • University of Michigan

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

61 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults 65 years and older who reside in a participating country

La description

Inclusion Criteria:

  • 65 years and older
  • Resides in a participating country

Exclusion Criteria:

  • None

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cas uniquement
  • Perspectives temporelles: Transversale

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Survey 1 Statin - May cause harm
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 1 Stain - May lack benefit
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may lack benefit.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 1 Statin - May cause harm and lack benefit
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm and lack benefit.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 1 PPI - May cause harm
Participants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may be causing harm.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 1 PPI - May lack benefit
Participants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may lack benefit.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 1 PPI - May cause harm and lack benefit
Participants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may be causing harm and lack benefit.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 2 Statin - May cause harm and lack benefit
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm and lack benefit.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 2 Statin - Cardiologist
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin previously started by a cardiologist.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 2 Statin - Daughter Preference
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient's adult daughter prefers for her to continue the medication.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 2 Statin - Husband Stroke
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient's husband previously had a stroke after he stopped his statin.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 2 Statin - Flier
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient saw an educational flier about strokes in the waiting room.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
Survey 2 Statin - Difficulty Maintaining Lifestyle Changes
Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient recognizes that they have had difficulty exercising and eating healthier foods.
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin."
Délai: 1 year
Level of agreement with the primary care provider's recommendation to stop the medication presented in the hypothetical scenario (1=strongly disagree, 6=strongly agree)
1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 décembre 2020

Achèvement primaire (Réel)

31 décembre 2021

Achèvement de l'étude (Réel)

31 décembre 2021

Dates d'inscription aux études

Première soumission

9 décembre 2020

Première soumission répondant aux critères de contrôle qualité

15 décembre 2020

Première publication (Réel)

21 décembre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HUM00183129

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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