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

11 de enero de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

10184

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

61 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Adults 65 years and older who reside in a participating country

Descripción

Inclusion Criteria:

  • 65 years and older
  • Resides in a participating country

Exclusion Criteria:

  • None

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Solo caso
  • Perspectivas temporales: Transversal

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin."
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de diciembre de 2020

Finalización primaria (Actual)

31 de diciembre de 2021

Finalización del estudio (Actual)

31 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

9 de diciembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

15 de diciembre de 2020

Publicado por primera vez (Actual)

21 de diciembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de enero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

11 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HUM00183129

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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