Diabetes Communication and Treatment Burden

University of California, Davis24 enrolled

Overview

The objective of this proposal is to pilot test two types of pre-visit planning, where clinical staff reviews charts and talks to patients before their doctors appointments, to reduce the burden of diabetes care on the patient without increasing the visit workload during busy primary care clinics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Multiple Chronic Conditions

Interventions

CI-PVP (context-informed pre-visit planning)OTHER

may experience a single additional phone call from clinic staff in addition to the standard clinic staff chart review, email and/or phone call prior to diabetes office visit

Standard PVP (pre-visit planning)OTHER

standard clinic staff chart review, email and/or phone call prior to diabetes office visit

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients: * patient at the UCD ACC family medicine residency clinic * age 18+, * has diabetes per Diabetes Registry (HealthyPlanet2020) * PLUS at least one other chronic condition * attends a primary care office visit (in-person or telehealth) during the study initial data collection period with a physician who is participating in the study * speaks and writes English well enough to complete a written or oral survey * consents to participate PCPs: -sees patients as a primary care physician at the study clinic site Exclusion Criteria: * does not meet inclusion criteria

Locations (1)

University of California, Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

Pilot feasibility

patients reached by phone for PVP call after assigned to call; # patients recruited successfully who were eligible; # questions completed on the surveys; # calls made to each patient and to patients total per # patients reached and # patients enrolled; # patients who completed all surveys; qualitative interviews will discuss challenges, barriers, and other feasability concerns to scaling this pilot trial to a definitive multi-center trial

Time frame: at completion of study, 4 months after last study visit

Pilot acceptability)

a short survey measuring PCPs perception of the visit's difficulty, hassle and effort; qualittive interviews with patients, providers and those conducting the intervention PVP calls

Time frame: after each clinic visit, within 2 weeks; at end of study

Secondary Outcomes

Treatment Burden of Diabetes Care Questionnaire (TBQ)

a validated survey that measures patient self-assessment of chronic disease care burden; 13 items on a 5 point Likert scale, 13-65, higher score is worse

Time frame: change from baseline to 4 months post visit

Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection

a validated survey that measures patient's self-assessed ability to handle financial aspects of chronic disease care; 5 items on a 5 point Likert scale, 5-25, higher score is worse

Time frame: change from baseline to 4 months post visit

Healthcare Climate Questionnaire (HCQ)

a validated survey of patient experience with their healthcare; 6 items on a 7 point Likert scale, 6-42, higher score is better

Time frame: change from baseline to 4 months post visit

Data from ClinicalTrials.gov

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