Diabetes Communication and Treatment Burden

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Multiple Chronic Conditions
• Intervention / Treatment: Other: CI-PVP (context-informed pre-visit planning); Other: Standard PVP (pre-visit planning)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Enhanced PVP	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
Active Comparator: Standard; Standard PVP	Other: Standard PVP (pre-visit planning); standard clinic staff chart review, email and/or phone call prior to diabetes office visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Physician Job Satisfaction Scale	validated survey on elements of physician job satisfaction	change from baseline to 4 months post visit
Maslach Burnout Inventory Human Services Survey for Medical Personnel		change from baseline to 4 months post visit
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
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Elizabeth Magnan, MD, UCDavis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Disease; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: 1619593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan to share anonymized or de-identified data per IRB approval to researchers at my institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No