Pre-Visit Prioritization for Complex Patients With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Usual Care Control; Behavioral: Pre-Visit Tool

• Registration Number: NCT02375932
• Lead Sponsor: Kaiser Permanente

Brief Summary

Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. The investigators propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the electronic health record (EHR) that will enable complex patients to easily define care priorities for their upcoming visit.

Detailed Description

Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. For these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. In parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. These twin trends present a formidable challenge to effective diabetes primary care. We hypothesize that among complex patients not meeting diabetes management goals, a web-based health IT tool to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) and then submit these priorities directly into the electronic health record (EHR) for a scheduled visit with their primary care provider will result in more effective diabetes management over time. To test this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the EHR that will enable complex patients to easily define care priorities for their upcoming visit.

Study Timeline

• Study First Submitted: 2015-02-24
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2016-10-21
• Study Completion: 2017-10-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Current adult member (> 21 years old)
• Diagnosis of type 2 diabetes with most recent HbA1c > 8.0%
• English as primary language
• Registered on kp.org.

Patient

Exclusion Criteria

• Excluded by PCP, and/or: terminal illness, in hospice care or reside in a long-term care facility, severe mental illness (e.g. schizophrenia or personality disorder), currently or recently pregnant, and/or significant dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Control	Usual Care Control	Patients whose primary care physicians are allocated to the control arm will continue with usual care
Pre-Visit Tool	Pre-Visit Tool	Patients whose primary care physicians are allocated to the intervention arm will receive a secure electronic message shortly after scheduling an appointment with their provider asking them to complete a pre-visit prioritization survey using the kp.org patient portal

Primary Outcome Measures

Name	Time	Method
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)	1 year after enrollment	We will compare HbA1c control (% patients \< 7.0% and mean HbA1c levels) between intervention and control arms

Secondary Outcome Measures

Name	Time	Method
Patient assessment of visit communication (measures of communication quality using validated instruments)	Shortly after visit with PCP	We will call a subset of patients in the intervention and control arms after attending a visit with their PCP to assess measures of communication quality using validated instruments