scholarly journals Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention

Endocrine ◽  
2021 ◽  
Author(s):  
Marleen Kunneman ◽  
Megan E. Branda ◽  
Jennifer L. Ridgeway ◽  
Kristina Tiedje ◽  
Carl R. May ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Decision Making ◽  
Mixed Methods ◽  
Medication Adherence ◽  
Usual Care ◽  
Cluster Randomized Trial ◽  
Patient Knowledge ◽  
Cluster Randomized

Abstract Purpose To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. Methods In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. Results We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. Conclusions Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. Clinical trial registration ClinicalTrial.gov: NCT01502891.

scholarly journals Evaluation of an mHealth-enabled hierarchical diabetes management intervention in primary care in China (ROADMAP): A cluster randomized trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (9) ◽  
pp. e1003754
Author(s):  
Weiping Jia ◽  
Puhong Zhang ◽  
Dalong Zhu ◽  
Nadila Duolikun ◽  
Hong Li ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Blood Glucose ◽  
Usual Care ◽  
Diabetes Management ◽  
Blood Glucose Monitoring ◽  
Management Intervention ◽  
Relative Improvement ◽  
Cluster Randomized

Background Glycemic control remains suboptimal in developing countries due to critical system deficiencies. An innovative mobile health (mHealth)-enabled hierarchical diabetes management intervention was introduced and evaluated in China with the purpose of achieving better control of type 2 diabetes in primary care. Methods and findings A community-based cluster randomized controlled trial was conducted among registered patients with type 2 diabetes in primary care from June 2017 to July 2019. A total of 19,601 participants were recruited from 864 communities (clusters) across 25 provinces in China, and 19,546 completed baseline assessment. Moreover, 576 communities (13,037 participants) were centrally randomized to the intervention and 288 communities (6,509 participants) to usual care. The intervention was centered on a tiered care team–delivered mHealth-mediated service package, initiated by monthly blood glucose monitoring at each structured clinic visit. Capacity building and quarterly performance review strategies upheld the quality of delivered primary care. The primary outcome was control of glycated hemoglobin (HbA1c; <7.0%), assessed at baseline and 12 months. The secondary outcomes include the individual/combined control rates of blood glucose, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C); changes in levels of HbA1c, BP, LDL-C, fasting blood glucose (FBG), and body weight; and episodes of hypoglycemia. Data were analyzed using intention-to-treat (ITT) generalized estimating equation (GEE) models, accounting for clustering and baseline values of the analyzed outcomes. After 1-year follow-up, 17,554 participants (89.8%) completed the end-of-study (EOS) assessment, with 45.1% of them from economically developed areas, 49.9% from urban areas, 60.5 (standard deviation [SD] 8.4) years of age, 41.2% male, 6.0 years of median diabetes duration, HbA1c level of 7.87% (SD 1.92%), and 37.3% with HbA1c <7.0% at baseline. Compared with usual care, the intervention led to an absolute improvement in the HbA1c control rate of 7.0% (95% confidence interval [CI] 4.0% to 10.0%) and a relative improvement of 18.6% (relative risk [RR] 1.186, 95% CI 1.105 to 1.267) and an absolute improvement in the composite ABC control (HbA1c <7.0%, BP <140/80 mm Hg, and LDL-C <2.6 mmol/L) rate of 1.9% (95% CI 0.5 to 3.5) and a relative improvement of 21.8% (RR 1.218, 95% CI 1.062 to 1.395). No difference was found on hypoglycemia episode and weight gain between groups. Study limitations include noncentralized laboratory tests except for HbA1c, and caution should be exercised when extrapolating the findings to patients not registered in primary care system. Conclusions The mHealth-enabled hierarchical diabetes management intervention effectively improved diabetes control in primary care and has the potential to be transferred to other chronic conditions management in similar contexts. Trial registration Chinese Clinical Trial Registry (ChiCTR) IOC-17011325.

scholarly journals Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Yolanda Ramallo-Fariña ◽  
Miguel Angel García-Bello ◽  
Lidia García-Pérez ◽  
Mauro Boronat ◽  
Ana M Wägner ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Health Care ◽  
Decision Making ◽  
Usual Care ◽  
Health Care Professionals ◽  
Entire Study ◽  
Multicomponent Interventions ◽  
Combined Intervention

BACKGROUND Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals. OBJECTIVE This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care. METHODS The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both. In the intervention for patients, participants received an educational group program and were monitored and supported by logs, a web-based platform, and automated SMS. Those in the intervention for professionals also received an educational program, a decision support tool embedded in the electronic clinical record, and periodic feedback about patients’ results. A total of 2334 people with T2DM, regardless of glycated hemoglobin (HbA<sub>1c</sub>) levels and without diabetes-related complications, were included. The primary end point was change in HbA<sub>1c</sub> level. The main analysis was performed using multilevel mixed models. RESULTS For the overall sample, the intervention for patients attained a significant mean reduction in HbA<sub>1c</sub> levels of ‒0.27 (95% CI ‒0.45 to ‒0.10) at month 3 and ‒0.26 (95% CI ‒0.44 to ‒0.08) at month 6 compared with usual care, which remained marginally significant at month 12. A clinically relevant reduction in HbA<sub>1c</sub> level was observed in 35.6% (191/537) of patients in the intervention for patients and 26.0% (152/586) of those in usual care at month 12 (<i>P</i>=.006). In the combined intervention, HbA<sub>1c</sub> reduction was significant until month 18 (181/557, 32.6% vs 140/586, 23.9%; <i>P</i>=.009). Considering the subgroup of patients uncontrolled at baseline, all interventions produced significant reductions in HbA<sub>1c</sub> levels across the entire study period: ‒0.49 (95% CI ‒0.70 to ‒0.27) for the intervention for patients, ‒0.35 (95% CI ‒0.59 to ‒0.14) for the intervention for professionals, and ‒0.35 (95% CI ‒0.57 to ‒0.13) for the combined intervention. Differences in HbA<sub>1c</sub> for the area under the curve considering the entire period were significant for the intervention for patients and the combined intervention compared with usual care (<i>P</i>=.03 for both). Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure. CONCLUSIONS In uncontrolled patients, the intervention for patients at baseline provided clinically relevant and significant longer-term reductions of HbA<sub>1c</sub> levels. The intervention for professionals and combined intervention also improved the cardiovascular risk profile of patients. CLINICALTRIAL ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227

scholarly journals Effectiveness of two procedures for deploying a facilitated collaborative modeling implementation strategy—the PVS-PREDIAPS strategy—to optimize type 2 diabetes prevention in primary care: the PREDIAPS cluster randomized hybrid type II implementation trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Alvaro Sanchez ◽  
◽  
Susana Pablo ◽  
Arturo Garcia-Alvarez ◽  
Silvia Dominguez ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Diabetes Prevention ◽  
Implementation Strategy ◽  
Type Ii ◽  
Collaborative Process ◽  
Type 2 Diabetes Prevention ◽  
Cluster Randomized ◽  
Implementation Trial

Abstract Background The most efficient procedures to engage and guide healthcare professionals in collaborative processes that seek to optimize practice are unknown. The PREDIAPS project aims to assess the effectiveness and feasibility of different procedures to perform a facilitated interprofessional collaborative process to optimize type 2 diabetes prevention in routine primary care. Methods A type II hybrid cluster randomized implementation trial was conducted in nine primary care centers of the Basque Health Service. All centers received training on effective healthy lifestyle promotion. Headed by a local leader and an external facilitator, centers conducted a collaborative structured process—the PVS-PREDIAPS implementation strategy—to adapt the intervention and its implementation to their specific context. The centers were randomly allocated to one of two groups: one group applied the implementation strategy globally, promoting the cooperation of all health professionals from the beginning, and the other performed it sequentially, centered first on nurses, who later sought the pragmatic cooperation of physicians. The following patients were eligible for inclusion: all those aged ≥ 30 years old with at least one known cardiovascular risk factor and an impaired fasting glucose level (≥ 110-125 mg/dl) but without diabetes who attended centers during the study period. The main outcome measures concerned changes in type 2 diabetes prevention practice indicators after 12 months. Results After 12 months, 3273 eligible patients at risk of type 2 diabetes had attended their family physician at least once, and of these, 490 (15%) have been addressed by assessing their healthy lifestyles in both comparison groups. The proportion of at-risk patients receiving a personalized prescription of lifestyle change was slightly higher (8.6%; range 13.5-5.9% vs 6.8%; range 7.2-5.8%) and 2.3 times more likely (95% CI for adjusted hazard ratio, 1.38-3.94) in the sequential than in the global centers, after 8 months of the intervention program implementation period. The probability of meeting the recommended levels of physical activity and fruit and vegetable intake were four- and threefold higher after the prescription of lifestyle change than only assessment and provision of advice. The procedure of engagement in and execution of the implementation strategy does not modify the effect of prescribing healthy habits (p interaction component of intervention by group, p > 0.05). Discussion Our results show that the PVS-PREDIAPS implementation strategy manages to integrate interventions with proven efficacy in the prevention of type 2 diabetes in clinical practice in primary care. Further, they suggest that implementation outcomes were somewhat better with a sequential facilitated collaborative process focused on enhancing the autonomy and responsibility of nurses who subsequently seek a pragmatic cooperation of GPs. Trial registration Clinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017—retrospectively registered.

scholarly journals Optimal cut-off points for adherence measure among patients with type 2 diabetes in primary care clinics: a retrospective analysis

2021 ◽  
Vol 12 ◽  
pp. 204062232199026
Author(s):  
Ming Tsuey Lim ◽  
Norazida Ab Rahman ◽  
Xin Rou Teh ◽  
Chee Lee Chan ◽  
Shantini Thevendran ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Medication Adherence ◽  
Poor Adherence ◽  
Adherence Measure ◽  
Primary Care Clinics ◽  
Assessment Period ◽  
Hba1c Target ◽  
Optimal Adherence

Background: Medication adherence measures are often dichotomized to classify patients into those with good or poor adherence using a cut-off value ⩾80%, but this cut-off may not be universal across diseases or medication classes. This study aimed to examine the cut-off value that optimally distinguish good and poor adherence by using the medication possession ratio (MPR) and proportion of days covered (PDC) as adherence measures and glycated hemoglobin (HbA1c) as outcome measure among type 2 diabetes mellitus (T2DM) patients. Method: We used pharmacy dispensing data of 1461 eligible T2DM patients from public primary care clinics in Malaysia treated with oral antidiabetic drugs between January 2018 and May 2019. Adherence rates were calculated during the period preceding the HbA1c measurement. Adherence cut-off values for the following conditions were compared: adherence measure (MPR versus PDC), assessment period (90-day versus 180-day), and HbA1c target (⩽7.0% versus ⩽8.0%). Results: The optimal adherence cut-offs for MPR and PDC in predicting HbA1c ⩽7.0% ranged between 86.1% and 98.3% across the two assessment periods. In predicting HbA1c ⩽8.0%, the optimal adherence cut-offs ranged from 86.1% to 92.8%. The cut-off value was notably higher with PDC as the adherence measure, shorter assessment period, and a stricter HbA1c target (⩽7.0%) as outcome. Conclusion: We found that optimal adherence cut-off appeared to be slightly higher than the conventional value of 80%. The adherence thresholds may vary depending on the length of assessment period and outcome definition but a reasonably wise cut-off to distinguish good versus poor medication adherence to be clinically meaningful should be at 90%.

scholarly journals Medication adherence among patients with Type 2 diabetes: A mixed methods study

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0207583 ◽  
Author(s):  
Nouf M. Aloudah ◽  
Neil W. Scott ◽  
Hisham S. Aljadhey ◽  
Vera Araujo-Soares ◽  
Khalid A. Alrubeaan ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Mixed Methods ◽  
Medication Adherence ◽  
Mixed Methods Study

scholarly journals Quality of Life and Associated Factors among Primary Care Asian Patients with Type 2 Diabetes Mellitus

2019 ◽  
Vol 16 (19) ◽  
pp. 3561 ◽  
Author(s):  
Hardesh Dhillon ◽  
Rusli Bin Nordin ◽  
Amutha Ramadas
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Primary Care ◽  
Type 2 Diabetes Mellitus ◽  
Medication Adherence ◽  
Well Being ◽  
Care Clinic

Diabetes complications, medication adherence, and psychosocial well-being have been associated with quality of life (QOL) among several Western and Asian populations with diabetes, however, there is little evidence substantiating these relationships among Malaysia’s unique and diverse population. Therefore, a cross-sectional study was conducted in a Malaysian public primary care clinic among 150 patients diagnosed with type 2 diabetes mellitus (T2DM). Structured and validated questionnaires were used to investigate the associations between demographic, clinical, and psychological factors with QOL of the study participants. Approximately three-quarters of patients had a good-excellent QOL. Diabetes-related variables that were significantly associated with poor QOL scores included insulin containing treatment regimens, poor glycemic control, inactive lifestyle, retinopathy, neuropathy, abnormal psychosocial well-being, higher diabetes complication severity, and nonadherence (p < 0.05). The main predictors of a good-excellent QOL were HbA1c ≤ 6.5% (aOR = 20.78, 95% CI = 2.5175.9, p = 0.005), normal anxiety levels (aOR = 5.73, 95% CI = 1.8–18.5, p = 0.004), medication adherence (aOR = 3.35, 95% CI = 1.3–8.7, p = 0.012), and an aDCSI score of one and two as compared to those greater than or equal to four (aOR = 7.78, 95% CI = 1.5–39.2, p = 0.013 and aOR = 8.23, 95% CI = 2.1–32.8, p = 0.003), respectively. Medication adherence has also been found to be an effect modifier of relationships between HbA1c, depression, anxiety, disease severity, and QOL. These predictors of QOL are important factors to consider when managing patients with T2DM.

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