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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Pladevall 2015.

Study characteristics
Methods A randomized controlled trial to provide adherence information and motivational interviewing to improve diabetes and lipid control
RCT (NA clusters and NA providers), conducted in 1) Study participants were members of a large health system (Henry Ford Health System, primary care) serving southeast Michigan and metropolitan Detroit. 2) Clinicians trained in providing adherence information and nurses and pharmacists trained in providing motivational interviewing (MI). Six coaches (3 pharmacists and 3 registered nurses) passed the training; 4 of these coaches were also certified diabetes educators. In United States of America.
3 arms: 1. Control (UC ‐ usual care) (control arm) and 2. Intervention 1 (AI ‐ medication adherence information) (intervention arm), 3. Intervention 2 (AI + MI ‐ medication adherence information + motivational interviewing) (other arm)
Participants Control arm N: 567
Intervention arm N: 569, 556, NA
Diabetes type: 4
Mean age: 64.23 ± 9.3
% Male: 50.66
Longest follow‐up: 36 months
Interventions Control arm: (UC ‐ usual care)
Intervention arm: (AI ‐ medication adherence information)
1) Facilitated relay of clinical information
2) Patient education
Intervention arm: (AI + MI ‐ medication adherence information + motivational interviewing)
1) Case management
2) Team change
3) Facilitated relay of clinical information
4) Patient education
Outcomes Glycated haemoglobin
Low‐density lipoprotein
Funding source "This project was made possible through funding from the National Institute of Diabetes and Digestive and Kidney (R01DK064695 to Drs Pladevall and Williams), the National Institute of Allergy and Infectious Diseases (R01AI079139 to Dr Williams), and the National Heart Lung and Blood Institute (R01HL079055 and R01HL118267 to Dr Williams), National Institutes of Health and the Fund for Henry Ford Hospital (to Drs Pladevall and Williams)."
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A random number generator was first used to randomly sort each participating physician’s list of enrolled patients. The order of treatment arm assignment was then randomly selected for each physician’s patient list of participating patients. The team statistician notified the project co‐ordinator, who provided this information on treatment assignment to the clinical team.
Allocation concealment (selection bias) Low risk A random number generator was first used to randomly sort each participating physician’s list of enrolled patients. The order of treatment arm assignment was then randomly selected for each physician’s patient list of participating patients. The team statistician notified the project co‐ordinator, who provided this information on treatment assignment to the clinical team.
Patient's baseline characteristics (selection bias) Low risk Table 1. There were small but statistically significant differences in the mean age (P = 0.029).
Patient's baseline outcomes (selection bias) High risk Table 1. There were small but statistically significant differences in baseline A1C levels (P = 0.036) and baseline high‐density lipoprotein cholesterol levels (P = 0.033) between study arms.
Incomplete outcome data (attrition bias) Low risk They lost a total of 180 patients out of 1692 randomised (10.6%). They lost 57/567 patients in the control arm (10.1%), 69/569 in the AI group (12.1%) and 54/556 in the AI + MI group (9.7%). Low and balanced numbers. Reasons partly reported.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Our outcomes of interest were objectively measured (HbA1c and LDL).
Selective reporting (reporting bias) Low risk Prospectively registered protocol. All outcomes reported.
Risk of contamination (other bias) Low risk None.
Other bias Unclear risk In order to meet recruiting goals, 2 different waves of patient recruitment were implemented on 19 June 2008 and 13 October 2008. Patient participation was poor, with slightly less than half (49%) of patients having 1 or more MI sessions at 18 months following randomisation. Moreover, patients who might have benefited the most from the intervention (i.e. individuals with the lowest levels of adherence) were also the ones least likely to participate (selection bias). Unfortunately, it was beyond the scope of the current study to objectively measure whether such discussions (between the provider and the patient) occurred or whether this information was ignored (medication adherence information).