Clinical trial NCT04568382: Diabetes Communication and Treatment Burden
Official title: The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Multiple Chronic Conditions
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pilot feasibility
timeFrame: at completion of study, 4 months after last study visit
measure: Pilot acceptability)
timeFrame: after each clinic visit, within 2 weeks; at end of study
Secondary outcomes:
measure: Treatment Burden of Diabetes Care Questionnaire (TBQ)
timeFrame: change from baseline to 4 months post visit
measure: Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection
timeFrame: change from baseline to 4 months post visit
measure: Healthcare Climate Questionnaire (HCQ)
timeFrame: change from baseline to 4 months post visit
measure: Patient Self-Activation Measure (PAM-13) short form
timeFrame: change from baseline to 4 months post visit
measure: Perceived Diabetes Self-Management Scale
timeFrame: change from baseline to 4 months post visit
measure: SF-12, Short Form 12 questions Health Survey
timeFrame: change from baseline to 4 months post visit
measure: Discussion of social determinants of health (SDH) during clinic visit, self-reported
timeFrame: after each clinic visit, within 2 weeks
measure: HgbA1c value
timeFrame: change from baseline to 4 months post visit
measure: Blood pressure measurement
timeFrame: change from baseline to 4 months post visit
measure: Body Mass Index
timeFrame: change from baseline to 4 months post visit
measure: Physician Job Satisfaction Scale
timeFrame: change from baseline to 4 months post visit
measure: Maslach Burnout Inventory Human Services Survey for Medical Personnel
timeFrame: change from baseline to 4 months post visit
measure: Depression symptoms
timeFrame: change from baseline to 4 months post visit
measure: Anxiety Symptoms
timeFrame: change from baseline to 4 months post visit
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: UCDavis
name: Elizabeth Magnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magnan E, Gosdin M, Tancredi D, Jerant A. Pilot randomized controlled trial Protocol: Life context-informed pre-visit planning to improve care plans for primary care patients with multiple chronic conditions including diabetes. J Multimorb Comorb. 2021 Dec 1;11:26335565211062387. doi: 10.1177/26335565211062387. eCollection 2021 Jan-Dec.