Impact of Decision Aids to Enhance Shared Decision Making for Diabetes (DAD)
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Minnesota
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Albert Lea, Minnesota, Yhdysvallat, 56007
- MCHS-Albert Lea
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Austin, Minnesota, Yhdysvallat, 55912
- MCHS-Austin
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Kasson, Minnesota, Yhdysvallat, 55944
- Mayo Family Clinic
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Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic
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Rochester, Minnesota, Yhdysvallat, 55904
- Olmsted Medical Center
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Statin Choice Decision Aid
Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.
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Statin Choice Cards
Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
|
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Active Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Decisional quality (knowledge, decisional conflict, and satisfaction)
Aikaikkuna: Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter
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Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Provider satisfaction
Aikaikkuna: Immediately following clinical encounter
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Immediately following clinical encounter
|
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Patient medication adherence
Aikaikkuna: 6-months following clinical encounter
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6-months following clinical encounter
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Victor Montori, M.D., M.Sc., Mayo Clinic
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
- Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013 Aug 8;13:301. doi: 10.1186/1472-6963-13-301.
- Ruud KL, Leblanc A, Mullan RJ, Pencille LJ, Tiedje K, Branda ME, Van Houten HK, Heim SR, Kurland M, Shah ND, Yawn BP, Montori VM. Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices. Trials. 2013 Aug 21;14:267. doi: 10.1186/1745-6215-14-267.
- Tiedje K, Shippee ND, Johnson AM, Flynn PM, Finnie DM, Liesinger JT, May CR, Olson ME, Ridgeway JL, Shah ND, Yawn BP, Montori VM. 'They leave at least believing they had a part in the discussion': understanding decision aid use and patient-clinician decision-making through qualitative research. Patient Educ Couns. 2013 Oct;93(1):86-94. doi: 10.1016/j.pec.2013.03.013. Epub 2013 Apr 15.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DK084009
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