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Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial.

ABSTRACT: OBJECTIVE:To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece. DESIGN:Open-label cluster randomised controlled trial. SETTING:Primary and secondary care practices across Greece. PARTICIPANTS:5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients). INTERVENTION:Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both consider important when choosing among antihyperglycaemic medications. Patients in the control arm received usual care. OUTCOME MEASURES:The primary outcome was patient's level of decisional comfort after the initial clinical encounter. Secondary outcomes included patient's knowledge about type 2 diabetes and medications, and patient's and clinician's satisfaction. Adherence to prescribed antihyperglycaemic medication and change in glycated haemoglobin were assessed at 24?weeks. RESULTS:Patients in both arms had similar scores in overall decisional comfort (mean difference between the usual care and decision aid arms -6.9, 95% CI -21.5 to 7.7) and its subscales. Patients' knowledge was high in both arms (mean difference 2.3%, 95% CI -15.7% to 20.4%). Patients and clinicians in both groups were equally satisfied with the decision-making. No significant difference in medication adherence and glycaemic control was found across arms. Clinicians found the decision aid useful and reported that its integration in their daily routine was easy. CONCLUSIONS:The decision aid was implemented and positively received in the clinical setting in Greece, in line with the patient-centred approach endorsed by current guidelines. However, this trial yielded imprecise results in terms of patient outcomes. Further research is needed to investigate the interaction between the patient and the clinician in order to clarify the association between the use of decision aids and implementation of shared decision-making. TRIAL REGISTRATION NUMBER:NCT01861756. Pre-results.

SUBMITTER: Karagiannis T

PROVIDER: S-EPMC5129072 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial.

Karagiannis Thomas T Liakos Aris A Branda Megan E ME Athanasiadou Eleni E Mainou Maria M Boura Panagiota P Goulis Dimitrios G DG LeBlanc Annie A Montori Victor M VM Tsapas Apostolos A

BMJ open 20161114 11

<h4>Objective</h4>To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece.<h4>Design</h4>Open-label cluster randomised controlled trial.<h4>Setting</h4>Primary and secondary care practices across Greece.<h4>Participants</h4>5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients).<h4>Intervention</h4>Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both con ...[more]

PMID: 28186933

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Project description:Decision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.To determine whether a decision aid increases informed choice about mammography screening programme participation.A representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and ?2-tests.1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention.This paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public.German Clinical Trials Register DRKS00005176.

Project description:BackgroundBy providing information on the relative merits and potential harms of the options available and a framework to clarify preferences, decision aids can improve knowledge and realistic expectations and decrease decisional conflict in individuals facing decisions between alternative forms of action. Decision-making about prenatal testing for fetal abnormalities is often confusing and difficult for women and the effectiveness of decision aids in this field has not been established. This study aims to test whether a decision aid for prenatal testing of fetal abnormalities, when compared to a pamphlet, improves women's informed decision-making and decreases decisional conflict.Methods/designA cluster designed randomised controlled trial is being conducted in Victoria, Australia. Fifty General Practitioners (GPs) have been randomised to one of two arms: providing women with either a decision aid or a pamphlet. The two primary outcomes will be measured by comparing the difference in percentages of women identified as making an informed choice and the difference in mean decisional conflict scores between the two groups. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation. The sample size of 159 women in both arms of the trial has been calculated to detect a difference of 18% (50 to 68%) in informed choice between the two groups. The required numbers have been adjusted to accommodate the cluster design, miscarriage and participant lost--to--follow up. Baseline characteristics of women will be summarised for both arms of the trial. Similarly, characteristics of GPs will be compared between arms. Differences in the primary outcomes will be analysed using 'intention-to-treat' principles. Appropriate regression techniques will adjust for the effects of clustering and include covariates to adjust for the stratifying variable and major potential confounding factors.DiscussionThe findings from this trial will make a significant contribution to improving women's experience of prenatal testing and will have application to a variety of maternity care settings. The evaluation of a tailored decision aid will also have implications for pregnancy care providers by identifying whether or not such a resource will support their role in providing prenatal testing information.

Project description:OBJECTIVE:To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN:Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING:22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS:279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS:The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS:ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated?haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS:The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER:ISRCTN77300204; Results.

Project description:Background and aimsAs treatment for opioid use disorder (OUD) expands within general healthcare settings such as primary care, mechanisms to facilitate decision-making processes are increasingly necessary. Decision aids have the capacity to bolster existing resources in diverse treatment settings by increasing knowledge of treatment options and facilitating shared decision making. The aim of this study is to develop and test a patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD) that assists individuals with OUD in making informed decisions about treatment at the time of initial clinical visit. Use of the PtDA-MOUD will be further tested in diverse treatment settings within the California Hub and Spoke System developed under the SAMHSA State Targeted Response to the Opioid Crisis grants.MethodsThe PtDA-MOUD was iteratively developed with input from a scientific expert panel and both patient and provider focus groups, incorporating International Patient Decision Aid Standards. Thirty-six patients with OUD entering treatment pilot tested the PtDA and completed assessments, and results from clinical records were compared with matched controls who did not receive the PtDA. A clinical profile based on assessment data was created for use within the clinical visit.ResultsThe developed decision aid provides information on MOUD and captures patient characteristics relevant to medication treatment decisions. Feedback indicated that the PtDA-MOUD was feasible to implement and useful. Though the small sample size limited the ability to detect significant differences (p > .05), a greater number of individuals who reviewed the PtDA (37%) were inducted on MOUD than controls (11%) and received MOUD for more days (M = 14.0, SD = 24.7) than controls (M = 8.4; SD = 22.5). Moreover, the difference in means for days receiving MOUD had an approximately medium effect size (r = 0.25).ConclusionsPatient perceptions of the decision aid were favorable and it showed promise as a tool in the OUD treatment process. Pilot testing results suggested preliminary positive effects on MOUD initiation. Future phases of this study will further investigate the usefulness of this tool. ClinicalTrials.govIdentifier:NCT03394261.

Project description:ObjectiveTo determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT).DesignA cluster RCT.Setting49 general practices in UK randomised into intervention (n=25) and control (n=24).ParticipantsGeneral practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy.Exclusion criteriacurrently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and anlaysis.InterventionBrief training of clinicians and use of PDA with patients in single consultation.Primary outcomesDecision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c).Secondary outcomesKnowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications.ResultsIntervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of 'hypo', 'weight gain', 'complications'; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups.ConclusionsUse of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice. ISRCTN TRIALS REGISTER NUMBER: 14842077.

Project description:ImportanceThe Pediatric Emergency Care Applied Research Network prediction rules for minor head trauma identify children at very low, intermediate, and high risk of clinically important traumatic brain injuries (ciTBIs) and recommend no computed tomography (CT) for those at very low risk. However, the prediction rules provide little guidance in the choice of home observation or CT in children at intermediate risk for ciTBI.ObjectiveTo compare a decision aid with usual care in parents of children at intermediate risk for ciTBI.Design, settings, and participantsThis cluster randomized trial was conducted in 7 geographically diverse US emergency departments (EDs) from April 1, 2014, to September 30, 2016. Eligible participants were emergency clinicians, children ages 2 to 18 years with minor head trauma at intermediate risk for ciTBI, and their parents.InterventionsClinicians were randomly assigned (1:1 ratio) to shared decision-making facilitated by the Head CT Choice decision aid or to usual care.Main outcomes and measuresThe primary outcome, selected by parent stakeholders, was knowledge of their child's risk for ciTBI and the available diagnostic options. Secondary outcomes included decisional conflict, parental involvement in decision-making, the ED CT rate, 7-day health care utilization, and missed ciTBI.ResultsA total of 172 clinicians caring for 971 children (493 decision aid; 478 usual care) with minor head trauma at intermediate risk for ciTBI were enrolled. The patient mean (SD) age was 6.7 (7.1) years, 575 (59%) were male, and 253 (26%) were of nonwhite race. Parents in the decision aid arm compared with the usual care arm had greater knowledge (mean [SD] questions correct: 6.2 [2.0] vs 5.3 [2.0]; mean difference, 0.9; 95% CI, 0.6-1.3), had less decisional conflict (mean [SD] decisional conflict score, 14.8 [15.5] vs 19.2 [16.6]; mean difference, -4.4; 95% CI, -7.3 to -2.4), and were more involved in CT decision-making (observing patient involvement [OPTION] scores: mean [SD], 25.0 [8.5] vs 13.3 [6.5]; mean difference, 11.7; 95% CI, 9.6-13.9). Although the ED CT rate did not significantly differ (decision aid, 22% vs usual care, 24%; odds ratio, 0.81; 95% CI, 0.51-1.27), the mean number of imaging tests was lower in the decision aid arm 7 days after injury. No child had a missed ciTBI.Conclusions and relevanceUse of a decision aid in parents of children at intermediate risk of ciTBI increased parent knowledge, decreased decisional conflict, and increased involvement in decision-making. The intervention did not significantly reduce the ED CT rate but safely decreased health care utilization 7 days after injury.Trial registrationClinicalTrials.gov Identifier: NCT02063087.

Dataset Information

Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial.

Publications

Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial.

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