Clinical Trial

. 2015 Oct 1:8:523.

doi: 10.1186/s13104-015-1480-6.

Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin

Emily K Acton¹, Charles E Leonard^{2

3}, Mark H Schutta⁴, Serena Cardillo^{5

6}, Andrea B Troxel^{7

8}, Rebecca Trotta⁹, Sean Hennessy^{10

11

12}

Affiliations

¹ Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. eacton@sas.upenn.edu.
² Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. celeonar@mail.med.upenn.edu.
³ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. celeonar@mail.med.upenn.edu.
⁴ Penn Rodebaugh Diabetes Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Mark.Schutta@uphs.upenn.edu.
⁵ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
⁶ Penn Rodebaugh Diabetes Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
⁷ Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. atroxel@mail.med.upenn.edu.
⁸ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. atroxel@mail.med.upenn.edu.
⁹ Department of Nursing, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. Rebecca.Trotta@uphs.upenn.edu.
¹⁰ Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.
¹¹ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.
¹² Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.

PMID: 26429339
PMCID: PMC4590692
DOI: 10.1186/s13104-015-1480-6

Clinical Trial

Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin

Emily K Acton et al. BMC Res Notes. 2015.

. 2015 Oct 1:8:523.

doi: 10.1186/s13104-015-1480-6.

Authors

Emily K Acton¹, Charles E Leonard^{2

3}, Mark H Schutta⁴, Serena Cardillo^{5

6}, Andrea B Troxel^{7

8}, Rebecca Trotta⁹, Sean Hennessy^{10

11

12}

Affiliations

¹ Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. eacton@sas.upenn.edu.
² Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. celeonar@mail.med.upenn.edu.
³ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. celeonar@mail.med.upenn.edu.
⁴ Penn Rodebaugh Diabetes Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Mark.Schutta@uphs.upenn.edu.
⁵ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
⁶ Penn Rodebaugh Diabetes Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
⁷ Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. atroxel@mail.med.upenn.edu.
⁸ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. atroxel@mail.med.upenn.edu.
⁹ Department of Nursing, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. Rebecca.Trotta@uphs.upenn.edu.
¹⁰ Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.
¹¹ Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.
¹² Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.

PMID: 26429339
PMCID: PMC4590692
DOI: 10.1186/s13104-015-1480-6

Abstract

Background: To examine the feasibility of implementing clinician-supported inpatient self-managed insulin to aid in the planning of a randomized clinical trial.

Results: We conducted a proof-of-concept interventional study of inpatients with diabetes mellitus who had hospital orders for basal-bolus or sliding scale insulin. Patients meeting inclusion criteria were offered the opportunity to manage their own basal-bolus insulin with support from a diabetes nurse practitioner. Over a three-month screening period, we conducted 361 screens in 336 patients, only eleven of whom met all inclusion criteria. None of these eleven eligible patients elected to enroll. The most common reason for refusal was lack of interest in self-managing insulin while acutely ill (36 %).

Discussion: Future studies of patient-managed in-hospital insulin should consider enrolling less acutely ill patients with longer anticipated lengths of stay.

Trials registration: NCT02144441.

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References

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Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin

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Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin

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