Impact of Decision Aids to Enhance Shared Decision Making for Diabetes (DAD)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Minnesota
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Albert Lea, Minnesota, Verenigde Staten, 56007
- MCHS-Albert Lea
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Austin, Minnesota, Verenigde Staten, 55912
- MCHS-Austin
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Kasson, Minnesota, Verenigde Staten, 55944
- Mayo Family Clinic
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Rochester, Minnesota, Verenigde Staten, 55904
- Olmsted Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Actieve vergelijker: 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.
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Diabetes Medication Choice cards
Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Decisional quality (knowledge, decisional conflict, and satisfaction)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Provider satisfaction
Tijdsspanne: Immediately following clinical encounter
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Immediately following clinical encounter
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Patient medication adherence
Tijdsspanne: 6-months following clinical encounter
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6-months following clinical encounter
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Victor Montori, M.D., M.Sc., Mayo Clinic
Publicaties en nuttige links
Algemene publicaties
- 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.
Nuttige links
Studie record data
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Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DK084009
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