Qbsafe: a randomized trial of a novel intervention to improve care for people living with type 2 diabetes

Ended Project Grant Awarded Last action

Award ID
R01DK129616
Recipient
Awarding agency
Obligated
$1,627,440

Award facts

Completion date
Originally
Place of performance
Connecticut, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Clinical guidelines, performance measures, and clinical trials for patients with type 2 diabetes mellitus (DM2) have traditionally focused on achieving certain levels of glycemic control. Yet, when glycemic control is the main focus of diabetes care, important aspects of patients' health and wellbeing may be overlooked or undervalued. For patients with poor glycemic control, clinicians typically respond by intensifying the regimen, all too often without attention to the workload this imposes on patients, their capacity to carry out the treatment plan, or the contextual factors involved. As a result, diabetes and its treatment may disrupt and interfere with valued activities and interests (i.e., cause worsening "illness intrusiveness"), and actually worsen how a person feels or functions. The goal of our program is to promote a paradigm shift in DM2 care: from reaching HBA1C targets to a whole-person approach that responds to the situation of each patient and reduces illness intrusiveness. Here, we propose to test a novel intervention to treat DM2 focused on quality of life, burden of treatment (medication administration, costs, and monitoring), safety (reducing adverse effects), and avoidance of future events (acute and chronic diabetes complications) - the qbsafe approach. We have previously developed an agenda setting kit (ask) for patients to use during their routine office visits. The ask is comprised of (a) a set of conversation cards designed to enable patients to identify aspects of qbsafe that are pertinent to their situation and to share them with their clinician to obtain their input; and (B) materials that help clinicians respond to patient concerns. We propose to conduct a clustered randomized trial at a federally qualified healthcare center in new haven, CT, and to randomize 10 primary care clinicians and 144 of their patients with DM2 and HBA1C >8% to receive usual care with or without qbsafe ask in order to achieve the following: aim 1: to determine the feasibility of the research procedures necessary to conduct a practice- based randomized trial to determine the clinical effectiveness of qbsafe ask in the care of patients with DM2. Aim 2: since a definitive trial will require some mechanistic evidence of efficacy, we will power this trial to also estimate the extent to which usual care with and without qbsafe ask can improve: aim 2A: patient-reported outcomes, principally illness intrusiveness (illness intrusiveness rating scale), as well as diabetes distress (diabetes distress scale), treatment burden (treatment burden questionnaire), hypoglycemia, and global quality of life (1-item analogue scale) at 6 months after the intervention. Aim 2B: clinical outcomes measured as change in HBA1C between baseline and 6 months. Aim 2C: patient-centered diabetes judged by (a) rating the audiovisual recordings of clinical encounters (including the time spent total and in discussing qbsafe domains), and (B) patient satisfaction (using the ambulatory cahps survey) and clinician satisfaction (using post-encounter survey) with how the encounter went. This work will provide necessary preliminary data for a multicenter randomized trial to determine the clinical effectiveness of qbsafe ask in diabetes care.

Transactions

Action Obligated Date
Amendment -$0
Amendment $16,559
Amendment $248,360
Amendment $248,360
Amendment $0
Amendment $269,641
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Amendment $269,641
Amendment $269,641
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Original award $305,238
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Subawards

Subrecipient Amount Awarded
University Of Maryland, Baltimore Dr. McCoy will provide subject matter expertise in the clinical care for people with DM2 in the primary care setting, informed by her experience integrating… $35,646
Mayo Clinic DRS. Montori and mccoy, CO-investigators on the proposal, will work closely with DR. Lipska to ensure successful conduct of the trial. Specifically, DR. Montori… $67,589
Fair Haven Community Health Clinic, Inc. DR. Anne camp and study staff at the fair haven community health care will collaborate with DR. Lipska at the yale school of medicine on the proposal to niddk… $130,347

Quick answers

Who received award R01DK129616?

R01DK129616 was awarded to Yale Univ by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on April 1, 2022.

How much is award R01DK129616 worth?

$1,627,440 has been obligated on R01DK129616.

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