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Pre-Visit Prioritization for Complex Patients With Diabetes

Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02375932
Acronym
PVP
Enrollment
146
Registered
2015-03-03
Start date
2015-03-31
Completion date
2017-10-31
Last updated
2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Electronic Medical Records, Primary Health Care, Diabetes Mellitus, Type 2

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.

Interventions

BEHAVIORALPre-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

Patients continue to receive usual care from their primary care provider

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)1 year after enrollmentWe will compare HbA1c control (% patients \< 7.0% and mean HbA1c levels) between intervention and control arms

Secondary

MeasureTime frameDescription
Patient assessment of visit communication (measures of communication quality using validated instruments)Shortly after visit with PCPWe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026