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

11. Januar 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

10184

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

61 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adults 65 years and older who reside in a participating country

Beschreibung

Inclusion Criteria:

  • 65 years and older
  • Resides in a participating country

Exclusion Criteria:

  • None

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Nur Fall
  • Zeitperspektiven: Querschnitt

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin."
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Dezember 2020

Primärer Abschluss (Tatsächlich)

31. Dezember 2021

Studienabschluss (Tatsächlich)

31. Dezember 2021

Studienanmeldedaten

Zuerst eingereicht

9. Dezember 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Dezember 2020

Zuerst gepostet (Tatsächlich)

21. Dezember 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Januar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Januar 2022

Zuletzt verifiziert

1. Januar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HUM00183129

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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