Diabetes Communication and Treatment Burden

NCT ID: NCT04568382

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Multiple Chronic Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention

Enhanced PVP

Group Type EXPERIMENTAL

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

Intervention Type 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

Standard PVP

Group Type ACTIVE_COMPARATOR

Standard PVP (pre-visit planning)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Standard PVP (pre-visit planning)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Marianne Magnan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Magnan, MD

Role: PRINCIPAL_INVESTIGATOR

UCDavis

Locations

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University of California, Davis

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34881189 (View on PubMed)

Other Identifiers

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1619593

Identifier Type: -

Identifier Source: org_study_id

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