Evidence map›Paper›PMID 34749816›Full record

ArticlePilot and feasibility studies2021

Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care.

Jennifer E Clark, Kasey R Boehmer, Maggie Breslin, Shanzay Haider, Weronika Pasciak, Derek Gravholt, Brianna B Sanchez, Sandra A Hartasanchez, Omar M El Kawkgi, Victor Montori and 1 more

Registry-linked trialAbstract read
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In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04514523 (QBSAfe), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04514523 nacompletednot on this map

QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

TypeinterventionalSponsorYale UniversityRan2020 to 2020Enrolled91ConditionsDiabetes, Diabetes MellitusArmsQBSAfe Toolkit
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jennifer E ClarkKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Kasey R BoehmerKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Maggie BreslinThe Patient Revolution, Rochester, MN, USA.
Shanzay HaiderSection of Endocrinology, Yale University School of Medicine, PO Box 208020, New Haven, CT, 06520, USA.
Weronika PasciakFrank H. Netter MD School of Medicine, Quinnipiac University, Hamden, CT, USA.
Derek GravholtKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Brianna B SanchezKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Sandra A HartasanchezKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Omar M El KawkgiKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Victor MontoriKnowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Kasia J LipskaSection of Endocrinology, Yale University School of Medicine, PO Box 208020, New Haven, CT, 06520, USA. kasia.lipska@yale.edu.ORCID http://orcid.org/0000-0002-0348-742X

Funding

DIABETES MELLITUS &DISORDERS OF METABOLISMT32DK007058 · NIDDK · YALE UNIVERSITY · PI SONIA CAPRIO, Kevan C Herold · 1986 to 2026
$9.6M
QBSafe: A novel approach to care for older, complex adults with type 2 diabetesR21AG061427 · NIA · YALE UNIVERSITY · PI LIPSKA, KASIA JOANNA, MONTORI, VICTOR MANUEL · 2019 to 2020
$467k
NCATS NIH HHS L30 TR002972NIA NIH HHS 5R21AG061427-02NIA NIH HHS R21 AG061427NIDDK NIH HHS T32 DK007058
6 · The paper itself

Abstract

backgroundDiabetes care has been traditionally focused on targeting certain levels of glycemic control. This narrow emphasis may impose burdens on patients, including high treatment costs, illness-related work, or side effects from medications, while leaving other patient needs and goals under-addressed. The authors aim to shift the paradigm of care for people with diabetes, to focus on quality of life, burden of treatment, safety, and avoidance of future events: the QBSAfe domains.

methodsWe describe a single-arm pilot study to assess the feasibility and acceptability of using the QBSAfe agenda setting kit (ASK) during routine clinical visits. The set of 14 conversation aid cards was co-developed with patients, family caregivers, and clinicians. The ASK will be used in the context of a clinic visit, which will be recorded by members of the study team to identify patterns of clinician-patient conversations. Feasibility will be measured by the number of participants recruited, time to goal accrual, and completeness of data collection; acceptability will be assessed using post-visit surveys of patients and clinicians. A subgroup of patients will be invited to participate in post-visit qualitative semi-structured interviews for additional feedback. This study will be conducted across three medical centers in the Midwest and East Coast of the USA. DISCUSSION: Current healthcare infrastructure and associated demands and pressures on clinicians make changes in care difficult. However, this intervention has the potential to shift conversations during clinical encounters so they can address and directly respond to patient needs, symptoms, and capacity. As part of the QBSAfe ASK, the authors are also actively collaborating with a variety of stakeholders to create tools to help clinicians respond more effectively to patient concerns as they are raised during the clinical encounters. Additional insights about the use of the QBSAfe approach in the virtual space will be gathered during the process of our study due to restrictions imposed upon face to face visit during the COVID-19 pandemic.

trial registrationClinicalTrials.gov , NCT04514523 . Registered 17 August 2020-retrospectively registered.

Indexed as

Chronic disease managementClinical toolkitConversation aidDiabetesPatient-centered

Identifiers

PMID34749816
PMCPMC8572684

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.