Diabetes Communication and Treatment Burden

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568382
• Other study ID #: 1619593
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2023
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Disease
• Multiple Chronic Conditions

Intervention

Other:
• CI-PVP (context-informed pre-visit planning)
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)
standard clinic staff chart review, email and/or phone call prior to diabetes office visit

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at completion of study, 4 months after last study visit
Primary	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	after each clinic visit, within 2 weeks; at end of study
Secondary	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	change from baseline to 4 months post visit
Secondary	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	change from baseline to 4 months post visit
Secondary	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	change from baseline to 4 months post visit
Secondary	Patient Self-Activation Measure (PAM-13) short form	a validated measure of patient participation in their own healthcare; 13 items on a 4 point Likert scale, 13-52, higher score is better	change from baseline to 4 months post visit
Secondary	Perceived Diabetes Self-Management Scale	a validated survey on the patients perception of their ability to care for their diabetes; 8 items on a 5 point Likert scale, 8-40 higher score is worse	change from baseline to 4 months post visit
Secondary	SF-12, Short Form 12 questions Health Survey	a validated 12 question survey on patient's physical and mental health	change from baseline to 4 months post visit
Secondary	Discussion of social determinants of health (SDH) during clinic visit, self-reported	a single question survey, self-reporting by the participant, if SDH were discussed between the doctor and the patient during the visit	after each clinic visit, within 2 weeks
Secondary	HgbA1c value	change in A1c level from baseline to post-study, using values nearest to study start and end dates	change from baseline to 4 months post visit
Secondary	Blood pressure measurement	systolic and diastolic blood pressure value pre and psot study, using measures closest to study start and end date, and area-under-the-curve for blood pressure in between.	change from baseline to 4 months post visit
Secondary	Body Mass Index	Body Mass Index change from beginning of study to the end of the study, using most recent height available	change from baseline to 4 months post visit
Secondary	Physician Job Satisfaction Scale	validated survey on elements of physician job satisfaction	change from baseline to 4 months post visit
Secondary	Maslach Burnout Inventory Human Services Survey for Medical Personnel		change from baseline to 4 months post visit
Secondary	Depression symptoms	change in symptom score, as measured by PHQ2 (0-6, higher is worse) or PHQ9 (0-27, higher is worse), as available, done within one month of study start and after visit by study end	change from baseline to 4 months post visit
Secondary	Anxiety Symptoms	change in symptom score, as measured by GAD2 (0-6, higher is worse) or GAD7 (0-21, higher is worse), as available, done within one month of study start and after visit by study end	change from baseline to 4 months post visit