Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: the enhancing outcomes through goal assessment and generating engagement in diabetes mellitus (ENGAGE-DM) pragmatic randomized trial
Open accessAbstract
BACKGROUND: Many factors contribute to suboptimal diabetes control including insufficiently-intensive treatment and non-adherence to medication and lifestyle. Determining which of these is most relevant for individual patients is challenging. Patient engagement techniques may help identify contributors to suboptimal adherence and address barriers (using motivational interviewing) and help facilitate choices among treatment augmentation options (using shared decision-making). These methods have not been used in combination to improve diabetes outcomes. OBJECTIVE: To evaluate the impact of a telephone-based patient-centered intervention on glycosylated hemoglobin (HbA1c) control for individuals with poorly-controlled diabetes. DESIGN: Two-arm pragmatic randomized control trial within an explanatory sequential mixed-methods design. SUBJECTS: 1,400 participants 18-64 years old with poorly-controlled type 2 diabetes. INTERVENTION: The intervention was delivered over the telephone by a clinical pharmacist and consisted of a 2-step process that integrated brief negotiated interviewing and shared decision-making to identify patient goals and options for enhancing diabetes management. MAIN MEASURES: The primary outcome was change in HbA1c. Secondary outcomes were medication adherence measures. Outcomes were evaluated using intention-to-treat principles; multiple imputation was used for missing values in the 12-month follow-up. We used information from pharmacist notes to elicit factors to potentially explain the intervention's effectiveness. KEY RESULTS: Participants had a mean age of 54.7 years (SD:8.3) and baseline HbA1c of 9.4 (SD:1.6). Change in HbA1c from baseline was -0.79 (SD:2.01) in the control arm and -0.75 (SD:1.76) in the intervention arm (difference:+0.04, 95%CI: -0.22, 0.30). There were no significant differences in adherence. In as-treated analyses, the intervention significantly improved diabetes control (-0.48, 95%CI: -0.91, -0.05). Qualitative findings provided several potential explanations for the findings, including insufficiently addressing patient barriers. CONCLUSIONS: A novel telephone-based patient-centered intervention did not improve HbA1c among individuals with poorly-controlled diabetes, though as-treated analyses suggest that the intervention was effective for those who received it. TRIAL REGISTRATION: ClinicalTrials.gov NCT02910089.
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One study reporting medication adherence found no between-group difference.
“one study did not find any between-group difference.28”
From Effectiveness of synchronous teleconsultation for patients with type 2 diabetes mellitus: a systematic review and meta-analysis (2023) · cites this paper as [28]
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- Authors
- Lauffenburger, J. C., Ghazinouri, R., Jan, S., Makanji, S., Ferro, C. A., Lewey, J., Wittbrodt, E., Lee, J., Haff, N., Fontanet, C. P., & Choudhry, N. K.
- Affiliations
- Brigham and Women's Hospital (US)
- Rutgers, The State University of New Jersey (US)
- Hospital of the University of Pennsylvania (US)
- AstraZeneca (United States) (US)
- Corresponding author
- Lauffenburger, Julie C.
- ORCID
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2019-04-02
- Volume
- 14
- Issue
- 4
- Pages
- e0214754
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC6445420
- OpenAlex
- W2926719416
- Cited by
- 50
- References
- 42
- Citations by year
- 2026: 5 · 2025: 9 · 2024: 8 · 2023: 6 · 2022: 10 · 2021: 7 · 2020: 4 · 2019: 1
- FWCI
- 4.46
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Funders
- AstraZeneca
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 2 diabetes, uncontrolled diabetes, telephone-delivered intervention, patient engagement, motivational interviewing, shared decision-making, HbA1c, glycemic control, medication adherence, patient-centered care, barriers to adherence, treatment intensification, patient goals, as-treated analysis
- MeSH terms
- Adolescent, Adult, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Pharmacists, Telephone, Treatment Outcome, Behavior Control, Medication Adherence, Young Adult, Motivational Interviewing
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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