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Impact of Decision Aids to Enhance Shared Decision Making for Diabetes (DAD)

1. februar 2016 oppdatert av: Victor Montori, Mayo Clinic
The proposed trial seeks to determine the impact of patient decision aids versus usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization in nonurban practices in the Midwestern United States. Upon completion of this trial, the investigators will have new knowledge about both the effectiveness of diabetes decision aids in nonacademic nonurban practices and about the processes that promote or inhibit the successful implementation of patient decision aids in such practices.

Studieoversikt

Detaljert beskrivelse

Type 2 diabetes causes loss of quality and diminished duration of life for over 24 million Americans with great costs and heavy burden of treatment for both society and for affected families. Decision aids are tools that help clinicians involve patients in making deliberate choices by providing accessible information about the options available and their outcomes. We propose to conduct a cluster randomized trial to obtain an estimate of the impact of patient decision aids versus usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization.

Participating clinicians will be trained to use decision aid tools to discuss starting either new diabetes medications or new statins with their enrolled patients. Surveys completed by clinicians and patients will assess satisfaction with decision making and knowledge gained by patients. 3- and 6-month follow-up surveys completed by patients will assess adherence to chosen medications and sustained knowledge. Primary analysis will be conducted utilizing generalized linear models. Some visits will be video and/or audio recorded with permission, and a small subset of patients, clinicians, and support staff will be interviewed by an experienced qualitative researcher using a semi-structured interview guide.

Primary care practices were enrolled then matched by size (less than or equal to 2 clinicians or greater than 2 clinicians) and randomly allocated by a statistician to 1) the use of the Diabetes Medication Choice decision aid and usual care for lipid therapy medication (statin) discussion during the encounter with subjects or to 2) the use of the Statin Choice decision aid and usual care for antihyperglycemic mediations discussion during the encounter with subjects.

Studietype

Intervensjonell

Registrering (Faktiske)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Minnesota
      • Albert Lea, Minnesota, Forente stater, 56007
        • MCHS-Albert Lea
      • Austin, Minnesota, Forente stater, 55912
        • MCHS-Austin
      • Kasson, Minnesota, Forente stater, 55944
        • Mayo Family Clinic
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
      • Rochester, Minnesota, Forente stater, 55904
        • Olmsted Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Primary care provider is participating in trial
  • Are an adult (≥ 18 years) with type 2 diabetes
  • English speaking
  • Recognize their primary care provider as their main diabetes care provider
  • Declare being available for follow-up for six months after treatment decision

Exclusion Criteria:

- Have major barriers to provide written informed consent and to participate in shared decision making (i.e., severe vision or hearing impairment, cognitive impairment, non-English speaking)

Additional Inclusion Criteria for Diabetes Medication:

  • Have a clinical diagnosis of type 2 diabetes for one year or more (c-peptide test is not required)
  • Use 0, 1, or 2 oral hypoglycemic agents at maximum doses
  • Have stable but inadequate glycemic control or worsening glycemic control as identified by their most recent HbA1c measure (within 12 months of the time of eligibility over 7.3%
  • Be identified by provider as a medically-appropriate candidate for diabetes medications, (i.e., have not contraindications to taking the medications, e.g., allergy).

Additional Exclusion Criteria for Diabetes Medication:

- Use insulin therapy.

Additional Inclusion Criteria for Cardiovascular Medication:

  • Have a clinical diagnosis of type 2 diabetes for any duration (c-peptide test is not required).
  • Be identified by provider as a medically-appropriate candidate for statins, (i.e., have not contraindications to taking the medications, e.g., allergy).

Additional Exclusion Criteria for Cardiovascular Medication:

- Use a statin currently.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Statin Choice Decision Aid
Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.
Statin Choice Cards
Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
Aktiv komparator: Diabetes Medication Choice Decision Aid
Subjects will receive an intervention of Diabetes Medication Choice Decision Aid and usual care for lipid therapy medication discussion with their clinician.
Diabetes Medication Choice cards
Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Decisional quality (knowledge, decisional conflict, and satisfaction)
Tidsramme: Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter
Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter

Sekundære resultatmål

Resultatmål
Tidsramme
Provider satisfaction
Tidsramme: Immediately following clinical encounter
Immediately following clinical encounter
Patient medication adherence
Tidsramme: 6-months following clinical encounter
6-months following clinical encounter

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Victor Montori, M.D., M.Sc., Mayo Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2010

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

4. desember 2009

Først innsendt som oppfylte QC-kriteriene

7. desember 2009

Først lagt ut (Anslag)

9. desember 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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