NCT01029288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable diabetes

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

December 4, 2009

Last Update Submit

February 1, 2016

Conditions

Diabetes

Keywords

DiabetesDecision aidCardiovascular riskPatient education

Outcome Measures

Primary Outcomes (1)

  • Decisional quality (knowledge, decisional conflict, and satisfaction)

    Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter

Secondary Outcomes (2)

  • Provider satisfaction

    Immediately following clinical encounter

  • Patient medication adherence

    6-months following clinical encounter

Study Arms (2)

Statin Choice Decision Aid

ACTIVE COMPARATOR

Subjects will receive an intervention of Statin Choice Decision Aid and usual care for antihyperglycemic medication discussion with their clinician.

Other: Statin Choice Decision AidOther: Usual care for antihyperglycemic medication

Diabetes Medication Choice Decision Aid

ACTIVE COMPARATOR

Subjects will receive an intervention of Diabetes Medication Choice Decision Aid and usual care for lipid therapy medication discussion with their clinician.

Other: Diabetes Medication Choice Decision AidOther: Usual care for lipid therapy medication

Interventions

Diabetes Medication Choice Decision AidOTHER

Diabetes Medication Choice cards

Diabetes Medication Choice Decision Aid
Statin Choice Decision AidOTHER

Statin Choice Cards

Statin Choice Decision Aid
Usual care for lipid therapy medicationOTHER

Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.

Diabetes Medication Choice Decision Aid
Usual care for antihyperglycemic medicationOTHER

Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.

Statin Choice Decision Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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)
  • 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).
  • \- Use insulin therapy.
  • 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).
  • \- Use a statin currently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

MCHS-Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

MCHS-Austin

Austin, Minnesota, 55912, United States

Location

Mayo Family Clinic

Kasson, Minnesota, 55944, United States

Location

Olmsted Medical Center

Rochester, Minnesota, 55904, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

  • 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.

    PMID: 23927490RESULT

  • 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.

    PMID: 25179289DERIVED

  • 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.

    PMID: 23965227DERIVED

  • 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.

    PMID: 23598292DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Victor Montori, M.D., M.Sc.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 9, 2009

Study Start

April 1, 2010

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

US(5)