FundingNational Institute of Diabetes and Digestive and Kidney Diseases of NIH (R34DK084009). Funding source had no role in the design, execution, analyses, or interpretation of the data.

DisclosureAuthors of this presentation have no disclosures concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation.

AcknowledgementsMayo Clinic: Sara Heim, Vicki Clark, Kasey Boehmer, Marc Matthews MD, Gregory Bartel MD, Jennifer Pecina MD, Laura Pelaez MDOlmsted Medical Center: Alice Medlyn RN, Linda Paradise RN, Randy Hemann MD, Daniel Swartz MD, Linda Williams MD, Craig Thauwald MD, Daniel Pesch MD, Shaun Dekutoski MD, Dale Loeffler DO

Decision Aids to Enhance Shared Decision Making in Diabetes: A Randomized TrialHolly Van Houten1, Megan Branda MS1, Nilay Shah PhD1, Barbara Yawn MD2, Annie LeBlanc PhD3, Laurie Pencille3, Kari Ruud MEd3, Marge Kurland2, Victor Montori MD3

1Division of Health Care Policy & Research , Mayo Clinic; 2Olmsted Medical Center, 3Knowledge and Evaluation Research Unit, Mayo Clinic

PURPOSEPURPOSE•To obtain estimates of the impact of patient decision aids versus usual care on measures of patient involvement in decision-making and diabetes control

METHODSMETHODSStudy Design•Practice-level, multi-site cluster randomized trial•Patient decision aids versus usual care•Randomized 10 participating primary care practices to implement either:

• Diabetes Medication Choice• Statin Choice

Study Population•Patients with diabetes were enrolled between March 2010 and July 2011 in rural primary care practices•Eligibility criteria:

• Age 18+ years• Type 2 diabetes• Maximum dosages of current medications• Planning to discuss changing/adding medication• HbA1c > 7.3 for diabetes discussion only

Data Collection•Abstraction from the medical & pharmacy records•Surveys administered to patients and clinicians

Demographics

*no significant differences between study arms

RESULTSRESULTS

*modified and adjusted by discussion and study arm

LIMITATIONSLIMITATIONS•This was a feasibility study

• Too small and brief to conclude about the effectiveness of decision aids in diabetes

• Efficacy and feasibility of decision aids confirmed with suggestive results of improved medication adherence

•Several lessons to improve the feasibility of larger study were drawn

http://kerunit.e-bm.orghttp://kercards.e-bm.info/

http://shareddecisions.mayoclinic.org/

For more information

Overall(n=103)

Decision Aid(n=53)

Usual Care(n=50)

Discussion to start medication

Diabetes 39 (37.9%)

27 (50.9%) 12 (24.0%)

Statin 64 (62.1%)

26 (49.1%) 38 (76.0%)

Male 63 (61.2%)

37 (69.8%) 26 (52.0%)

Age (years) 57.6 ± 10.9

57.9 ± 10.5 57.3 ± 11.4

DM duration 5+ yrs

50 (48.5%)

29 (54.7%) 21 (42.0%)

CONCLUSIONSCONCLUSIONS

•We were able to deliver decision aids to intervention patients in nonurban clinics, but the trial had important feasibility challenges

•Decision aids • more likely to spark conversation about medications• inform patients about options, risks and benefits of each medication

•Clinicians felt decision aid was easy• to deliver during patient office visit• for support staff to integrate in daily activities

•Pharmacy• DA patients were more adherent and persistent

IMPLICATIONS FOR PRACTICE OR POLICYIMPLICATIONS FOR PRACTICE OR POLICY

• Tough to implement shared decision making in a pragmatic trial when

• quality metrics are disease centric,

• patients do not expect involvement, and

• clinicians are not trained to share decisions.

• Both trials and decision aids must be designed to fit the characteristics of users and practices.

• Much more work is needed in this area.

Decision Aid Usual Care P-Value

Patient post-visit survey n=52 n=47

Discussion to start medication

40 (76.9%) 21 (44.7%) <0.0001

Diabetes Knowledge questions

3.1 (1.0) 1.8 (0.8) 0.0005

Decisional Conflict Subscale: information*

80.8 (1.8) 75.8 (1.5) <0.0001

Clinician post-visit survey n=49 n=47

Discussion to start medication

44 (89.9%) 32 (68.1%) 0.0417

Felt delivery of DA was very easy/easy

35 (81.4%) -- --

Felt support staff integration of DA was very easy/easy

35 (81.4%) -- --

Pharmacy Data n=43 n=44

Adherence > 80% 25 (58.1)% 20 (45.4%) 0.2859

Persistence (days) 189.8 (48.1) 97.6 (37.4) 0.0062