Efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients, a randomized controlled trial - "Pharm-MD" : Impact of clinical pharmacists in diabetes care.
Diabetes
Hemoglobin A1c
Managed care
Pharmacy
Journal
BMC endocrine disorders
ISSN: 1472-6823
Titre abrégé: BMC Endocr Disord
Pays: England
ID NLM: 101088676
Informations de publication
Date de publication:
16 Mar 2022
16 Mar 2022
Historique:
received:
19
05
2021
accepted:
08
03
2022
entrez:
17
3
2022
pubmed:
18
3
2022
medline:
29
3
2022
Statut:
epublish
Résumé
Diabetes mellitus affects 13% of American adults. To address the complex care requirements necessary to avoid diabetes-related morbidity, the American Diabetes Association recommends utilization of multidisciplinary teams. Research shows pharmacists have a positive impact on multiple clinical diabetic outcomes. Open-label randomized controlled trial with 1:1 assignment that took place in a single institution resident-run outpatient medicine clinic. Patients 18-75 years old with type 2 diabetes mellitus and most recent HbA1c ≥9% were randomized to standard of care (SOC) (continued with routine follow up with their primary provider) or to the SOC + pharmacist-managed diabetes clinic PMDC group (had an additional 6 visits with the pharmacist within 6 months from enrollment). Patients were followed for 12 months after enrollment. Data collected included HbA1c, lipid panel, statin use, blood pressure control, immunization status, and evidence of diabetic complications (retinopathy, nephropathy, neuropathy). Intention-to-treat and per-protocol analysis were performed. Forty-four patients were enrolled in the SOC + PMDC group and 42 patients in the SOC group. Average decrease in HbA1c for the intervention compared to the control group at 6 months was - 2.85% vs. -1.32%, (p = 0.0051). Additionally, the odds of achieving a goal HbA1c of ≤8% at 6 months was 3.15 (95% CI = 1.18, 8.42, p = 0.0222) in the intervention versus control group. There was no statistically significant difference in the remaining secondary outcomes measured. Addition of pharmacist managed care for patients with type 2 diabetes mellitus is associated with significant improvements in HbA1c compared with standard of care alone. Missing data during follow up limited the power of secondary outcomes analyses. ClinicalTrials.gov , ID: NCT03377127 ; first posted on 19/12/2017.
Sections du résumé
BACKGROUND
BACKGROUND
Diabetes mellitus affects 13% of American adults. To address the complex care requirements necessary to avoid diabetes-related morbidity, the American Diabetes Association recommends utilization of multidisciplinary teams. Research shows pharmacists have a positive impact on multiple clinical diabetic outcomes.
METHODS
METHODS
Open-label randomized controlled trial with 1:1 assignment that took place in a single institution resident-run outpatient medicine clinic. Patients 18-75 years old with type 2 diabetes mellitus and most recent HbA1c ≥9% were randomized to standard of care (SOC) (continued with routine follow up with their primary provider) or to the SOC + pharmacist-managed diabetes clinic PMDC group (had an additional 6 visits with the pharmacist within 6 months from enrollment). Patients were followed for 12 months after enrollment. Data collected included HbA1c, lipid panel, statin use, blood pressure control, immunization status, and evidence of diabetic complications (retinopathy, nephropathy, neuropathy). Intention-to-treat and per-protocol analysis were performed.
RESULTS
RESULTS
Forty-four patients were enrolled in the SOC + PMDC group and 42 patients in the SOC group. Average decrease in HbA1c for the intervention compared to the control group at 6 months was - 2.85% vs. -1.32%, (p = 0.0051). Additionally, the odds of achieving a goal HbA1c of ≤8% at 6 months was 3.15 (95% CI = 1.18, 8.42, p = 0.0222) in the intervention versus control group. There was no statistically significant difference in the remaining secondary outcomes measured.
CONCLUSIONS
CONCLUSIONS
Addition of pharmacist managed care for patients with type 2 diabetes mellitus is associated with significant improvements in HbA1c compared with standard of care alone. Missing data during follow up limited the power of secondary outcomes analyses.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov , ID: NCT03377127 ; first posted on 19/12/2017.
Identifiants
pubmed: 35296307
doi: 10.1186/s12902-022-00983-y
pii: 10.1186/s12902-022-00983-y
pmc: PMC8925057
doi:
Banques de données
ClinicalTrials.gov
['NCT03377127']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
69Informations de copyright
© 2022. The Author(s).
Références
Int J Clin Pharm. 2022 Feb;44(1):153-162
pubmed: 34637104
Ann Pharmacother. 1998 Jun;32(6):636-41
pubmed: 9640480
J Manag Care Spec Pharm. 2016 May;22(5):493-515
pubmed: 27123912
Pharm Pract (Granada). 2020 Jul-Sep;18(3):2000
pubmed: 32922572
Diabetes Care. 2004 Dec;27(12):2983-4
pubmed: 15562220
Am J Health Syst Pharm. 2013 May 15;70(10):877-86
pubmed: 23640349
Diabetes Care. 2016 Jan;39 Suppl 1:S6-12
pubmed: 26696683
BMJ. 2000 Aug 12;321(7258):405-12
pubmed: 10938048
Front Pharmacol. 2018 Apr 10;9:339
pubmed: 29692730
Ann Pharmacother. 2022 Feb;56(2):155-161
pubmed: 34105397
Am J Manag Care. 2005 Apr;11(4):253-60
pubmed: 15839185
Hypertension. 2021 Sep;78(4):966-972
pubmed: 34397278
Diabetes Care. 2001 Nov;24(11):1936-40
pubmed: 11679460
Am J Manag Care. 2018 Mar;24(4 Spec No.):SP116-SP119
pubmed: 29689147
Trials. 2018 Aug 24;19(1):458
pubmed: 30143033
Pharmacotherapy. 2006 Feb;26(2):248-53
pubmed: 16466329