- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04676282
Psychological and Clinical Factors That Predict Intent to Deprescribe Medications Among Older Adults
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 65 years and older
- Resides in a participating country
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin."
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HUM00183129
Plan for individuelle deltakerdata (IPD)
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