Diabetes Communication and Treatment Burden

NCT04568382 | Completed

• 1 other identifier: 1619593
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Treatment Burden of Diabetes Care Questionnaire (TBQ)

  change from baseline to 4 months post visit

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

  change from baseline to 4 months post visit

• Healthcare Climate Questionnaire (HCQ)

  change from baseline to 4 months post visit

• Patient Self-Activation Measure (PAM-13) short form

  change from baseline to 4 months post visit

• Perceived Diabetes Self-Management Scale

  change from baseline to 4 months post visit

Study Arms (2)

Intervention

EXPERIMENTAL

Enhanced PVP

Other: CI-PVP (context-informed pre-visit planning)

Standard

ACTIVE COMPARATOR

Standard PVP

Other: Standard PVP (pre-visit planning)

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

Intervention

Standard PVP (pre-visit planning) OTHER

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

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 34881189 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Magnan, MD

  UCDavis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 29, 2020
• Study Start: October 12, 2020
• Primary Completion: November 30, 2021
• Study Completion: June 30, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)