Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments pre-visit tool, usual care control
Sponsor Kaiser Permanente
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date March 2015
End date February 2018
Trial size 95 participants
Trial identifier NCT02375932, CN-13-1579, R01DK099108

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
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
pre-visit tool
Patients receive a secure electronic message from their primary providers asking them to prepare for their visit by reviewing important areas of care and identifying their top priorities for discussion at a scheduled visit
(Active Comparator)
Patients whose primary care physicians are allocated to the control arm will continue with usual care
usual care control
Patients continue to receive usual care from their primary care provider

Primary Outcomes

Measure
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)
time frame: 1 year after enrollment

Secondary Outcomes

Measure
Patient assessment of visit communication (measures of communication quality using validated instruments)
time frame: Shortly after visit with PCP

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

Primary care physicians (PCPs) at Kaiser Permanente Northern California with potentially eligible patients (type 2 diabetes and HbA1c > 8.0%) wil be recruited and consented to participate in this study. PCPs will review lists of potentially eligible patients of theirs (defined below). Patients approved by PCP's allocated to the intervention arm will be sent a secure message on the PCPs behalf asking them to review the Pre-Visit Prioritization Questionnaire to identify top priorities for discussion at the next scheduled visit. Patient 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

Additional Information

Official title Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes
Principal investigator Richard W Grant, MD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Kaiser Permanente.