Dataset Information

Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol.

ABSTRACT:

Background/aims

This paper describes the protocol for a feasibility study for a parallel Phase II randomised control trial (RCT) aiming to evaluate a novel decision-aid website (e-DA) to support young adults with bipolar II disorder (BPII), and their families.

Material and methods

The e-DA was developed according to the International Patient Decision-Aid Standards (IPDAS). Participants will be 40 young adults (18-30 years) referred to a specialist outpatient clinical facility, who have a confirmed clinical diagnosis of BPII. Participants will be randomised (1:1) to receive access to the clinic's online factsheets/website with (Intervention) or without (Control) the e-DA. A series of validated and purpose-designed questionnaires will be administered at baseline (T0), immediately post-decision (T1), and 3 months post-decision (T2). Questionnaires assess key decision-making constructs related to decision-making quality, including: decisional conflict, subjective and objective treatment knowledge, values-based informed choice, concordance between preferred/actual decision-making involvement, preparation for decision-making, and decisional regret. Self-report symptom severity and anxiety will ascertain the safety of e-DA use. The focus of analyses will be to assess effect sizes, in order to guide a future RCT.

Discussion

This feasibility study will evaluate a world first, evidence-based online decision-support resource, a DA website, for young adults with BPII and their families who are deciding on treatment options for relapse prevention. Findings will determine the e-DA's feasibility in RCT procedures (i.e., outpatient clinical setting) and provide estimates of effect sizes on outcomes related to improving treatment decision-making and patient outcomes in a sample of potential end-users, compared to usual care.

Trial registration

This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12617000840381.

SUBMITTER: Fisher A

PROVIDER: S-EPMC6234496 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol.

Fisher Alana A Sharpe Louise L Costa Daniel D Anderson Josephine J Manicavasagar Vijaya V Juraskova Ilona I

Contemporary clinical trials communications 20181109

<h4>Background/aims</h4>This paper describes the protocol for a feasibility study for a parallel Phase II randomised control trial (RCT) aiming to evaluate a novel decision-aid website (e-DA) to support young adults with bipolar II disorder (BPII), and their families.<h4>Material and methods</h4>The e-DA was developed according to the International Patient Decision-Aid Standards (IPDAS). Participants will be 40 young adults (18-30 years) referred to a specialist outpatient clinical facility, who ...[more]

PMID: 30456328

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Project description:BackgroundYoung adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We seek to (1) examine the feasibility, usability, and potential impact of a Shared Decision Making (SDM) Antipsychotic Medication Decision Aid (DA) on decision-making, adherence to the decision made, and service engagement among young adults with FEP and (2) understand the role of additional patient-level factors on SDM.MethodsA randomized controlled trial is being conducted in a coordinated specialty care community program for FEP in an urban setting. Eligible patients are randomly assigned to receive an intervention, the Antipsychotic Medication Decision Aid, or treatment as usual. Patients receive their assigned intervention before their medication appointment with the psychiatrist and complete four interviews: before the appointment (T0), after the appointment (T1), and at 3- and 6-month follow-ups (T2 and T3). The study staff and participating psychiatrists are not blinded to the intervention. The data are de-identified to maintain blinding during the analysis process. The primary aims are feasibility of intervention delivery and research procedures and preliminary impact of the intervention on SDM-related outcomes, medication adherence, and service engagement. As a secondary aim, we will explore the contribution of personality and motivation variables, clinical relationships, cognitive functioning, and mental-health-related stigma to SDM. If the sample size permits, we plan to conduct parametric tests such as independent-samples t tests at T1 to compare differences in SDM, adherence, and engagement scales. In the case of a small sample size, we will use non-parametric tests and descriptive statistics.DiscussionThis protocol outlines the methodology for a feasibility pilot comparing the effect of a novel SDM Antipsychotic Medication encounter DA with treatment as usual on SDM, medication adherence, and service engagement in FEP care. SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear. Understanding the potential contribution of an SDM Antipsychotic Medication DA compared with usual care in psychosis pharmacotherapy is critical. The study will help answer several key questions new to SDM research, including the contribution of personality and clinical relationships to SDM in mental health and psychosis in particular. The study will serve to gather feasibility data to inform future studies and scale-up.Trial registrationEthics approval was obtained through Temple University's institutional review board (IRB) and the City of Philadelphia's Department of Public Health IRB. The study has been retrospectively registered with ClinicalTrials.gov as NCT04373590 on 29 April 2020. https://clinicaltrials.gov/ct2/show/NCT04373590?term=NCT04373590&draw=2&rank=1.

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:BackgroundSevere Chronic Obstructive Pulmonary Disease patients are often unprepared to make decisions about accepting intubation for respiratory failure. We developed a Web-based decision aid, InformedTogether, to facilitate severe Chronic Obstructive Pulmonary Disease patients' preparation for decision making about whether to accept invasive mechanical ventilation for respiratory failure.ObjectiveWe describe feasibility testing of the InformedTogether decision aid.MethodsMixed methods, pre- and postintervention feasibility study in outpatient pulmonary and geriatric clinics. Clinicians used InformedTogether with severe Chronic Obstructive Pulmonary Disease patients. Patient-participants completed pre- and postassessments about InformedTogether use. The outcomes measured were the following: feasibility/acceptability, communication (Combined Outcome Measure for Risk Communication [COMRADE], Medical Communication Competency Scale [MCCS], Observing Patient Involvement [OPTION] scales), and effectiveness of InformedTogether on changing patients' knowledge, Decisional Conflict Scale, and motivation.ResultsWe enrolled 11 clinicians and 38 Chronic Obstructive Pulmonary Disease patients at six sites. Feasibility/acceptability: Clinicians and patients gave positive responses to acceptability questions (mean 74.1/89 max [SD 7.24] and mean 59.63/61 [SD 4.49], respectively). Communication: 96% of clinicians stated InformedTogether improved communication (modified MCCS mean 44.54/49 [SD 2.97]; mean OPTION score 32.03/48 [SD 9.27]; mean COMRADE Satisfaction 4.31/5.0 [SD 0.58]; and COMRADE Confidence 4.18/5.0 [SD 0.56]). Preference: Eighty percent of patients discussed preferences with their surrogates by 1-month. Effectiveness: Knowledge scores increased significantly after using InformedTogether (mean difference 3.61 [SD 3. 44], P=.001) and Decisional Conflict decreased (mean difference Decisional Conflict Scale pre/post -13.76 [SD 20.39], P=.006). Motivation increased after viewing the decision aid.ConclusionsInformedTogether supports high-quality communication and shared decision making among Chronic Obstructive Pulmonary Disease patients, clinicians, and surrogates. The increased knowledge and opportunity to deliberate and discuss treatment choices after using InformedTogether should lead to improved decision making at the time of critical illness.

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:BackgroundDecision 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.ObjectiveTo determine whether a decision aid increases informed choice about mammography screening programme participation.MethodsA 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 χ2-tests.Results1,206 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.ConclusionThis 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.Trial registrationGerman Clinical Trials Register DRKS00005176.

Project description:BACKGROUND:Humanitarian action in crisis zones is fraught with many challenges, including lack of timely and accessible research evidence to inform decision-making about humanitarian interventions. Evidence websites have the potential to address this challenge. Evidence Aid is the only evidence website designed for crisis zones that focuses on providing research evidence in the form of systematic reviews. The objective of this study is to explore stakeholders' views of Evidence Aid, contributing further to our understanding of the use of research evidence in decision-making in crisis zones. METHODS:We designed a qualitative user-testing study to collect interview data from stakeholders about their impressions of Evidence Aid. Eligible stakeholders included those with and without previous experience of Evidence Aid. All participants were either currently working or have worked within the last year in a crisis zone. Participants were asked to perform the same user experience-related tasks and answer questions about this experience and their knowledge needs. Data were analysed using a deductive framework analysis approach drawing on Morville's seven facets of the user experience - findability, usability, usefulness, desirability, accessibility, credibility and value. RESULTS:A total of 31 interviews were completed with senior decision-makers (n?=?8), advisors (n?=?7), field managers (n?=?7), analysts/researchers (n?=?5) and healthcare providers (n?=?4). Participant self-reported knowledge needs varied depending on their role. Overall, participants did not identify any 'major' problems (highest order) and identified only two 'big' problems (second highest order) with using the Evidence Aid website, namely the lack of a search engine on the home page and that some full-text articles linked to/from the site require a payment. Participants identified seven specific suggestions about how to improve Evidence Aid, many of which can also be applied to other evidence websites. CONCLUSIONS:Stakeholders in crisis zones found Evidence Aid to be useful, accessible and credible. However, they experienced some problems with the lack of a search engine on the home page and the requirement for payment for some full-text articles linked to/from the site.

Dataset Information

Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol.

Background/aims

Material and methods

Discussion

Trial registration

Publications

Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol.

Similar Datasets

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