Clinical trial NCT01029288: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Official title: Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Decision aid
Cardiovascular risk
Patient education
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-12-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decisional quality (knowledge, decisional conflict, and satisfaction)
timeFrame: Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter
Secondary outcomes:
measure: Provider satisfaction
timeFrame: Immediately following clinical encounter
measure: Patient medication adherence
timeFrame: 6-months following clinical encounter
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: MCHS-Albert Lea
state: Minnesota
city: Austin
country: United States
facility: MCHS-Austin
state: Minnesota
city: Kasson
country: United States
facility: Mayo Family Clinic
state: Minnesota
city: Rochester
country: United States
facility: Olmsted Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Victor Montori, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.