Dataset Information

Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients: A cluster-randomized trial (OPTIMAL).

ABSTRACT:

Objective

About 20% of patients with type 2 diabetes achieve all their treatment targets. Shared decision making (SDM) using a support aid based on the 5-years results of the ADDITION study on multifactorial treatment, could increase this proportion.

Research design and methods

Cluster-randomized trial in 35 former ADDITION primary care practices. Practices were randomized to SDM or care as usual (1:1). Both ADDITION and non-ADDITION type 2 diabetes patients, 60-80 years, known with diabetes for 8-12 years, were included. In the intervention group, patients were presented evidence about the relationship between treatment intensity and cardiovascular events. They chose intensive or less intensive treatment and prioritized their targets. After 1 year priorities could be rearranged.

Follow-up

24 months. Intention-to-treat analysis.

Main outcome measure

proportion of patients that achieved all three treatment targets.

Results

At baseline 26.4% in the SDM group (n=72) had already achieved all three treatment goals (CG: 23.5%, n=81). In the SDM group 44 patients chose intensive treatment, 25 continued their former less intensive treatment and three people switched from the more to the less intensive protocol. After 24 months 31.8% of the patients in the SDM group achieved all three treatment targets (CG: 25.3%), RR 1.26 (95% CI 0.81-1.95). Mean systolic blood pressure decreased in the SDM group (-5.4 mm Hg, P<.01), mean HbA1c and total cholesterol did not change.

Conclusions

Despite an already high baseline level of diabetes care, we found strong indications that SDM on both intensity of treatment and prioritizing treatment goals further improved outcomes.

SUBMITTER: Den Ouden H

PROVIDER: S-EPMC5600211 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients: A cluster-randomized trial (OPTIMAL).

Den Ouden Henk H Vos Rimke C RC Rutten Guy E H M GEHM

Health expectations : an international journal of public participation in health care and health policy 20170524 5

<h4>Objective</h4>About 20% of patients with type 2 diabetes achieve all their treatment targets. Shared decision making (SDM) using a support aid based on the 5-years results of the ADDITION study on multifactorial treatment, could increase this proportion.<h4>Research design and methods</h4>Cluster-randomized trial in 35 former ADDITION primary care practices. Practices were randomized to SDM or care as usual (1:1). Both ADDITION and non-ADDITION type 2 diabetes patients, 60-80 years, known wi ...[more]

PMID: 28544171

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Project description:BackgroundA birth plan (BP) is a written document in which the pregnant woman explains her wishes and expectations about childbirth to the health professionals and aims to facilitate her decision-making. Midwives' support to women during the development of the BP is essential, but it's unknown if shared decision making (SDM) is effective in birth plan counselling. We hypothesized that women who receive counselling based on SDM during their pregnancy are more likely to present their BP to the hospital, more satisfied with the childbirth experience, and have better obstetric outcomes than women who receive standard counselling. We also aimed to identify if women who presented BP to the hospital have better obstetric outcomes and more satisfied with the childbirth experience.MethodsThis was a randomised cluster trial involving four Primary Care Units. Midwives provided BP counselling based on SDM to the women in the intervention group (IG) during their pregnancy, along with a leaflet with evidence-based recommendations. Women in the control group (CG) only received the standard birth plan counselling from midwives. The primary outcomes were birth plan presentation to the hospital, obstetrics outcomes and satisfaction with childbirth experience. The Mackey Satisfaction with Childbirth Scale (MCSRS) was used to measure childbirth satisfaction.ResultsA total of 461 (95.5%) pregnant women received BP counselling (IG n = 214 and CG n = 247). Fewer women in the intervention group presented their BP to the hospital compared to those in the control group (57.8% vs 75.1%; p <0.001). Mean satisfaction with childbirth experience was high in the IG as well as the CG: 150.2 (SD:22.6) vs. 153.4 (SD:21.8); p = 0.224). The information received about childbirth during pregnancy was high in both groups (95.1% vs 94.8%; p = 1.0). Fewer women in the IG used analgesia epidural compared to those in the CG (84.7% vs 91.7%; p = 0.034); women who combined non-pharmacological and pharmacological methods for pain relief were more in number in the IG (48.9% vs 29.5%; p = 0.001) and women who began breastfeeding in the delivery room were more in number in the IG (83.9% vs 66.3%; p = 0.001). Women who presented their BP had a greater probability of using combined non-pharmacological and pharmacological methods for pain relief aOR = 2.06 (95% CI: 1.30-4.30) and early skin-to-skin contact aOR = 2.08 (95% CI: 1.07-4.04).ConclusionThis counselling intervention was not effective to increase the presentation of the BP to the hospital and women's satisfaction with childbirth; however, it was related to a lower usage of analgesia epidural, a higher combination of pharmacological and non-pharmacological methods for pain relief and the initiation of breastfeeding in the delivery room. Presenting the BP to the hospital increased the likelihood of using pharmacological and non-pharmacological methods for pain relief, and early skin-to-skin contact.

Project description:BACKGROUND:Care of patients with diabetes often occurs in the context of other chronic illness. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient. Guideline implementation interventions to date do not acknowledge these intricacies of clinical practice. As a result, patients and providers are left overwhelmed and paralyzed by the sheer volume of recommendations and tasks. An individualized approach to the patient with diabetes and multiple comorbid conditions using shared decision-making (SDM) and goal setting has been advocated as a patient-centred approach that may facilitate prioritization of treatment options. Furthermore, incorporating interprofessional integration into practice may overcome barriers to implementation. However, these strategies have not been taken up extensively in clinical practice. OBJECTIVES:To systematically develop and test an interprofessional SDM and goal-setting toolkit for patients with diabetes and other chronic diseases, following the Knowledge to Action framework. METHODS:1. Feasibility study: Individual interviews with primary care physicians, nurses, dietitians, pharmacists, and patients with diabetes will be conducted, exploring their experiences with shared decision-making and priority-setting, including facilitators and barriers, the relevance of a decision aid and toolkit for priority-setting, and how best to integrate it into practice.2. Toolkit development: Based on this data, an evidence-based multi-component SDM toolkit will be developed. The toolkit will be reviewed by content experts (primary care, endocrinology, geriatricians, nurses, dietitians, pharmacists, patients) for accuracy and comprehensiveness.3. Heuristic evaluation: A human factors engineer will review the toolkit and identify, list and categorize usability issues by severity.4. Usability testing: This will be done using cognitive task analysis.5. Iterative refinement: Throughout the development process, the toolkit will be refined through several iterative cycles of feedback and redesign. DISCUSSION:Interprofessional shared decision-making regarding priority-setting with the use of a decision aid toolkit may help prioritize care of individuals with multiple comorbid conditions. Adhering to principles of user-centered design, we will develop and refine a toolkit to assess the feasibility of this approach.

Project description:BackgroundCompeting health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.Methods/designA two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.DiscussionAn individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.Trial registrationClinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.

Project description:BackgroundMultimorbidity poses a challenge for decision-making processes and requires that more attention is paid to patient goals, preferences and needs; however, goal setting is not yet widely recognised as a core aspect of the shared decision-making (SDM) approach. This study aims to analyse clinician perceptions of the concept of goal setting within the context of SDM with older patients with multimorbidity.MethodsSemi-structured interviews with general practitioners (GPs) and clinical geriatricians (CGs) were analysed using a framework analysis. The integrative model of SDM was used to develop a categorisation matrix, including goal setting as an additional component.ResultsSixteen of the 33 clinicians mentioned explicit Goal setting as an integrated component of their definition of SDM, which was comparable to the number of clinicians who listed Patient values and preferences (n = 16), Doctor knowledge and recommendations (n = 19) and Make or explicitly defer a decision (n = 19), elements which are commonly considered to be important aspects of SDM. The other 17 clinicians (6 CGs and 11 GPs) did not mention Goal setting as an explicit component of SDM. Our analysis revealed two potential reasons for this observation. Besides the use of other terminology, part of clinicians viewed collaborative goal setting and SDM as separate but related processes.ConclusionsOur study on clinician perspectives highlighted goal setting as component of a SDM approach and could therefore be considered supportive of recent theoretical insights that SDM models that lack an explicit goal-setting component appear to be deficient and overlook an important aspect of engaging patients in decision-making, particularly for patients with complex multimorbidities. We therefore call for the further development of a comprehensive SDM approach for older patients with multimorbidity to include explicit and unequivocal goal setting elements to sufficiently meet the expectations and needs of clinicians and their patients.

Project description:ImportanceFor antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients.ObjectiveEstimate the effect of DMC on quality of the decision-making process and depression outcomes.Design, setting, and participantsWe conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid.InterventionDepression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations.Main outcomes and measuresDecision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9).ResultsWe enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P = .03), satisfaction (risk ratio [RR], from 1.25 [P = .81] to RR, 2.4 [P = .002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P < .001) and satisfaction (RR, 1.64; P = .02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms.Conclusions and relevanceThe DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression.Trial registrationclinicaltrials.gov Identifier: NCT01502891.

Dataset Information

Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients: A cluster-randomized trial (OPTIMAL).

Objective

Research design and methods

Follow-up

Main outcome measure

Results

Conclusions

Publications

Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients: A cluster-randomized trial (OPTIMAL).

Similar Datasets

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