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Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.

ABSTRACT: INTRODUCTION:The need for cataract surgery is on the rise due to our ageing population and high demands for greater visual functioning. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The present study aims to determine whether a decision aid increases informed decision about cataract surgery. METHODS AND ANALYSIS:A parallel randomised controlled trial (772 participants) will be conducted. The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China. Participants will be randomly assigned to receive either a patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention (time point (T)1), 2 weeks (T2) and 1 year (T3) after the intervention. The control group receives a traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise. The primary study outcome is the informed decision, the percentage of patients who have adequate knowledge and demonstrate consistency between attitudes and intentions. Secondary outcomes include perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year. ETHICS AND DISSEMINATION:Ethics approval was obtained from the Ethics Committee of Zhongshan Ophthalmic Center (reference number: 2019KYPJ090). Results will be published in peer-reviewed journals and presented at scientific meetings for academic audiences. TRIAL REGISTRATION NUMBER:NCT03992807.

SUBMITTER: Zheng Y

PROVIDER: S-EPMC7239516 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.

Zheng Yingfeng Y Zheng Yingfeng Y Qu Bo B Jin Ling L Wang Chunxiao C Zhong Yuxin Y He Mingguang M Liu Yizhi Y

BMJ open 20200518 5

<h4>Introduction</h4>The need for cataract surgery is on the rise due to our ageing population and high demands for greater visual functioning. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The present study aims to determine whether a decision aid increases informed decision about cataract surgery.<h4>Methods and analysis</h4>A parallel randomised controlled trial (772 participant ...[more]

PMID: 32430445

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Project description:INTRODUCTION:National guidelines recommend that all reproductive-age women with cancer be informed of their fertility risks and offered referral to fertility specialists to discuss fertility preservation options. However, reports indicate that only 5% of patients have consultations, and rates of long-term infertility-related distress remain high. Previous studies report several barriers to fertility preservation; however, initial success has been reported using provider education, patient decision aids and navigation support. This protocol will test effects of a multicomponent intervention compared with usual care on women's fertility preservation knowledge and decision-making outcomes. METHODS AND ANALYSIS:This cluster-randomised trial will compare the multicomponent intervention (provider education, patient decision aid and navigation support) with usual care (consultation and referral, if requested). One hundred newly diagnosed English-speaking women of reproductive age who are at risk of cancer-related infertility will be recruited from four regional oncology clinics.The Pathways patient decision aid website provides (1) up-to-date evidence and descriptions of fertility preservation and other family-building options, tailored to cancer type; (2) structured guidance to support personalising the information and informed decision-making; and (3) a printable summary to help women prepare for discussions with their oncologist and/or fertility specialist. Four sites will be randomly assigned to intervention or control groups. Participants will be recruited after their oncology consultation and asked to complete online questionnaires at baseline, 1 week and 2 months to assess their demographics, fertility preservation knowledge, and decision-making process and quality. The primary outcome (decisional conflict) will be tested using Fisher's exact test. Secondary outcomes will be assessed using generalised linear mixed models, and sensitivity analyses will be conducted, as appropriate. ETHICS AND DISSEMINATION:The University of Texas MD Anderson Cancer Center provided approval and ongoing review of this protocol. Results will be presented at relevant scientific meetings and submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03141437; Pre-results.

Project description:BackgroundA main element of patient-centred care, Patient Decision Aids (PtDAs) facilitate shared decision-making (SDM). A recent update of the International Patient Decision Aids Standards (IPDAS) emphasised patient involvement during PtDA development, but omitted a methodology for doing so. This article reports on the value of user-centred design (UCD) methods for the development of a PtDA that aims to support inflammatory arthritis patients in their choice between disease modifying anti-rheumatic drugs (DMARDs).MethodsThe IPDAS development process model in combination with UCD methods were applied. The process was overseen by an eight-member multidisciplinary steering group. Patients and health professionals were iteratively consulted. Qualitative in-depth interviews combined with rapid prototyping were conducted with patients to assess their needs for specific functionality, content and design of the PtDA. Group meetings with health professionals were organized to assess patients' needs and to determine how the PtDA should be integrated into patient pathways. The current literature was reviewed to determine the clinical evidence to include in the PtDA. To evaluate usability among patients, they were observed using the PtDA while thinking aloud and then interviewed.ResultsThe combination of patient interviews with rapid prototyping revealed that patients wanted to compare multiple DMARDs both for their clinical aspects and implications for daily life. Health professionals mainly wanted to refer patients to a reliable, easily adjustable source of information about DMARDs. A web-based PtDA was constructed consisting of four parts: 1) general information about SDM, inflammatory arthritis and DMARDs; 2) an application to compare particular DMARDs; 3) value clarification exercises; and 4) a printed summary of patients' notes, preferences, worries and questions that they could bring to discuss with their rheumatologist.ConclusionsThe study demonstrated that UCD methods can be of great value for the development of PtDAs. The early, iterative involvement of patients and health professionals was helpful in developing a novel user-friendly PtDA that allowed patients to choose between DMARDs. The PtDA fits the values of all stakeholders and easily integrates with the patient pathway and daily workflow of health professionals. This collaborative designed PtDA may improve SDM and patient participation in arthritis care.

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:IntroductionGout is increasing despite effective therapies to lower serum urate concentrations to 0.36?mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate-lowering therapy (ULT) is poor, with rates of less than 50% 1?year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. We aim to evaluate the effectiveness of use of a personal, self-management, 'smartphone' application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT.Methods and analysisSetting and designPrimary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.ParticipantsGP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.InterventionThe intervention group will have access to the Healthy.me app tailored for the self-management of gout. The control group patients will have access to the same app modified to remove all functions except the Gout Attack Diary.Primary and secondary outcomesThe proportion of patients whose serum urate concentrations are less than or equal to 0.36?mmol/L after 6 months. Secondary outcomes will be proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a ?30%?improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed 'dropout' rate 20%.Ethics and disseminationThis study has been approved by the University of New South Wales Human Research Ethics Committee. Study findings will be disseminated in international conferences and peer-reviewed journal.Trial registration numberACTRN12616000455460.

Project description:BACKGROUND:Hydroxyurea, chronic blood transfusions, and bone marrow transplantation are efficacious, disease-modifying therapies for sickle cell disease but involve complex risk-benefit trade-offs and decisional dilemma compounded by the lack of comparative studies. A patient decision aid can inform patients about their treatment options, the associated risks and benefits, help them clarify their values, and allow them to participate in medical decision making. OBJECTIVE:The objective of this study was to develop a literacy-sensitive Web-based patient decision aid based on the Ottawa decision support framework, and through a randomized clinical trial estimate the effectiveness of the patient decision aid in improving patient knowledge and their involvement in decision making. METHODS:We conducted population decisional needs assessments in a nationwide sample of patients, caregivers, community advocates, policy makers, and health care providers using qualitative interviews to identify decisional conflict, knowledge and expectations, values, support and resources, decision types, timing, stages and learning, and personal clinical characteristics. Interview transcripts were coded using QSR NVivo 10. Alpha testing of the patient decision aid prototype was done to establish usability and the accuracy of the information it conveyed, and then was followed by iterative cycles of beta testing. We conducted a randomized clinical trial of adults and of caregivers of pediatric patients to evaluate the efficacy of the patient decision aid. RESULTS:In a decisional needs assessment, 223 stakeholders described their preferences, helping to guide the development of the patient decision aid, which then underwent alpha testing by 30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders. In a randomized clinical trial, 120 participants were assigned to either the patient decision aid or standard care (SC) arm. Qualitative interviews revealed high levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making. On the acceptability survey, 72% (86/120) of participants rated the patient decision aid as good or excellent. Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months. However, there was no improvement in terms of the change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies at 6 months. The large amount of missing data from survey completion limited our ability to draw conclusions about the effectiveness of the patient decision aid. The patient decision aid met 61 of 62 benchmarks of the international patient decision aid collaboration standards for content, development process, and efficacy. CONCLUSIONS:We have developed a patient decision aid for sickle cell disease with extensive input from stakeholders and in a randomized clinical trial demonstrated its acceptability and utility in education and decision making. We were unable to demonstrate its effectiveness in improving patient knowledge and involvement in decision making. TRIAL REGISTRATION:ClinicalTrials.gov NCT03224429; https://clinicaltrials.gov/ct2/show/NCT03224429 and ClinicalTrials.gov NCT02326597; https://clinicaltrials.gov/ct2/show/NCT02326597.

Dataset Information

Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.

Publications

Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.

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