Pre-Visit Prioritization for Complex Patients With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— PVP  

Official title:

Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375932
• Other study ID #: CN-13-1579
• Secondary ID: R01DK099108
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: March 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 31, 2017
• Est. primary completion date: October 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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
• Usual Care Control
Patients continue to receive usual care from their primary care provider

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

References & Publications (4)

Grant RW, Adams AS, Bayliss EA, Heisler M. Establishing visit priorities for complex patients: A summary of the literature and conceptual model to guide innovative interventions. Healthc (Amst). 2013 Dec;1(3-4):117-122. — View Citation

Grant RW, Altschuler A, Uratsu CS, Sanchez G, Schmittdiel JA, Adams AS, Heisler M. Primary care visit preparation and communication for patients with poorly controlled diabetes: A qualitative study of patients and physicians. Prim Care Diabetes. 2017 Apr; — View Citation

Grant RW, Uratsu CS, Estacio KR, Altschuler A, Kim E, Fireman B, Adams AS, Schmittdiel JA, Heisler M. Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system. Contemp — View Citation

Zamudio CD, Sanchez G, Altschuler A, Grant RW. Influence of Language and Culture in the Primary Care of Spanish-Speaking Latino Adults with Poorly Controlled Diabetes: A Qualitative Study. Ethn Dis. 2017 Dec 7;27(4):379-386. doi: 10.18865/ed.27.4.379. eCo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)	We will compare HbA1c control (% patients < 7.0% and mean HbA1c levels) between intervention and control arms	1 year after enrollment
Secondary	Patient assessment of visit communication (measures of communication quality using validated instruments)	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	Shortly after visit with PCP