Dataset Information

Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice.

ABSTRACT:

Objective

To 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).

Design

A cluster RCT.

Setting

49 general practices in UK randomised into intervention (n=25) and control (n=24).

Participants

General 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 criteria

currently 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.

Intervention

Brief training of clinicians and use of PDA with patients in single consultation.

Primary outcomes

Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c).

Secondary outcomes

Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications.

Results

Intervention 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.

Conclusions

Use 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.

SUBMITTER: Mathers N

PROVIDER: S-EPMC3532975 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background:The process of developing patient management plans requires a series of clinical decision-making skills that can take years in practice to develop. For the inexperienced practitioner, providing a logical, systematic patient management framework may assist in clinical scenarios and accelerate their decision-making skill development. The purpose of this study was to assess whether a novel clinical management decision aid would improve the management decision-making of chiropractic students. Methods:A prospective before and after study tracked chiropractic master degree students in their final year of study across a 10-week period from February-May, 2017. Case-based assessments were performed at baseline, after initial exposure to the decision aid, and after repeated exposure over the course of the semester. Outcome measures included the results from the 3 assessments, scored out of 20 by two markers using a standardised marking rubric, then averaged and converted to percentages; and 2 feedback questionnaires, given after initial exposure and at 10 weeks. Results:A total of 75 students (44 males; 31 females) participated in the study. The mean score at baseline was 8.34/20 (41.7%) (95% CI: 7.98, 8.70; SD: 1.56) and after initial exposure was 9.52/20 (47.6%) (95% CI: 9.06, 9.98; SD: 2.02). The mean score after repeated exposure was 15.04/20 (75.2%) (95% CI: 14.46, 15.62; SD: 2.54). From baseline to initial exposure, there was a statistically significant absolute increase in mean score of 1.18/20 (5.9%) (95% CI: 0.6, 1.76; p < 0.0001), or a 2.82/20 (14.1%) relative improvement. From baseline to repeated exposure, there was a statistically significant absolute increase in mean score of 6.7/20 (33.5%) (95% CI: 6.02, 7.38; p < 0.0001), or a 16.06/20 (80.3%) relative improvement. The questionnaire results were also favourable. 56/75 (75%) participants agreed that the decision aid was easy to use and 46/75 (61%) of participants agreed that the decision aid improved their ability to integrate various management techniques. Conclusion:Implementing a clinical management decision aid into the teaching curriculum helped to facilitate the ability of chiropractic students to develop patient management plans.

Project description:General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication training are needed.1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations.The effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.The GPs will receive a questionnaire at baseline and after 6 months about attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction (Provider Decision Process Assessment Instrument). The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment (Morisky Compliance Scale), self-rated health (SF-12), enablement (Patient Enablement Instrument), and risk communication and decision-making effectiveness (COMRADE Scale). Prescriptions, contacts to the health services, and cholesterol level will be drawn from the registers.In each group, 12 consultations will be observed and tape-recorded. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme.The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to analyse adaptation of the intervention model to the specific context.This study aims at providing GPs and patients with a firm basis for active deliberation about preventive treatment options, with a view to optimising adherence to chosen treatment.ClinicalTrials.gov Protocol Registration System NCT01187056.

Project description:Objective: The objective was to develop a decision aid (DA) to facilitate shared decision making (SDM) around whether to obtain computed tomography (CT) imaging in patients presenting to the emergency department (ED) with suspected uncomplicated ureterolithiasis.Methods: We used evidence-based DA development methods, including qualitative methods and iterative stakeholder engagement, to develop and refine a DA. Guided by the Ottawa Decision Support Framework, International Patient Decision Aid Standards (IPDAS), and a steering committee made up of stakeholders, we conducted interviews and focus groups with a purposive sample of patients, community members, emergency clinicians, and other stakeholders. We used an iterative process to code the transcripts and identify themes. We beta-tested the DA with patient-clinician dyads facing the decision in real time.Results: From August 2018 to August 2019, we engaged 102 participants in the design and iterative refinement of a DA focused on diagnostic options for patients with suspected ureterolithiasis. Forty-six were ED patients, community members, or patients with ureterolithiasis, and the remaining were emergency clinicians (doctors, residents, advanced practitioners), researchers, urologists, nurses, or other physicians. Patients and clinicians identified several key decisional needs including an understanding of accuracy, uncertainty, radiation exposure/cancer risk, and clear return precautions. Patients and community members identified facilitators to SDM, such as a checklist of signs and symptoms. Many stakeholders, including both patients and ED clinicians, expressed a strong pro-CT bias. A six-page DA was developed, iteratively refined, and beta-tested.Conclusions: Using stakeholder engagement and qualitative inquiry, we developed an evidence-based DA to facilitate SDM around the question of CT scan utilization in patients with suspected uncomplicated ureterolithiasis. Future research will test the efficacy of the DA in facilitating SDM.