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Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. METHODS/DESIGN:A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. DISCUSSION:Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01876173.

SUBMITTER: Carroll SL

PROVIDER: S-EPMC4015905 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

Carroll Sandra L SL McGillion Michael M Stacey Dawn D Healey Jeff S JS Browne Gina G Arthur Heather M HM Thabane Lehana L

Trials 20131022

<h4>Background</h4>Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well- ...[more]

PMID: 24148851

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Project description:Background:Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes. Methods:Prior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group. Results:We identified 135 eligible patients. Eighty-two consented to the trial randomizing patients to usual care (n = 41) or PtDA intervention (n = 41). Feasibility outcome results were (1) referral rate at approximately 20/month, (2) recruitment rate 61%, and (3) successful delivery of PtDA and study management. Pre-consultation, PtDA patients scored lower on the DCS scale (mean, standard deviation [SD] 27.3 (18.4) compared to usual care, 49.4 (18.6); the between-group difference in means [95% confidence interval (CI)] was -?22.1[-?30.23, -?13.97]. A difference remained post-implantation 21.2 (11.7), PtDA intervention 29.9 (13.3), and usual care -?8.7 [-?14.61, -?2.86]. SURE test results supported DCS differences. The PtDA group scored higher on the ICD-related knowledge questions, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care. The mean [SD] number of correct knowledge responses out of 5 was 3.33(1.19) in the PtDA group and 2.62 (1.16) in usual care pre-implant. Concordance between values and decision choice found a strong association between predicted and actual ICD implant status in the intervention group. Conclusion:Our results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes. Trial registration:NCT01876173.

Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Project description:BackgroundAustralia has a comparatively high incidence of colorectal (bowel) cancer; however, population screening uptake using faecal occult blood test (FOBT) remains low. This study will determine the impact on screening participation of a novel, Internet-based Personalised Decision Support (PDS) package. The PDS is designed to measure attitudes and cognitive concerns and provide people with individually tailored information, in real time, that will assist them with making a decision to screen. The hypothesis is that exposure to (tailored) PDS will result in greater participation in screening than participation following exposure to non-tailored PDS or resulting from the current non-tailored, paper-based approach.Methods/designA randomised parallel trial comprising three arms will be conducted. Men and women aged 50-74 years (N = 3240) will be recruited. They must have access to the Internet; have not had an FOBT within the previous 12 months, or sigmoidoscopy or colonoscopy within the previous 5 years; have had no clinical diagnosis of bowel cancer. Groups 1 and 2 (PDS arms) will access a website and complete a baseline survey measuring decision-to-screen stage, attitudes and cognitive concerns and will receive immediate feedback; Group 1 will receive information 'tailored' to their responses in the baseline survey and group 2 will received 'non-tailored' bowel cancer information. Respondents in both groups will subsequently receive an FOBT kit. Group 3 (usual practice arm) will complete a paper-based version of the baseline survey and respondents will subsequently receive 'non-tailored' paper-based bowel cancer information with accompanying FOBT kit. Following despatch of FOBTs, all respondents will be requested to complete an endpoint survey. Main outcome measures are (1) completion of FOBT and (2) change in decision-to-screen stage. Secondary outcomes include satisfaction with decision and change in attitudinal scores from baseline to endpoint. Analyses will be performed using Chi-square tests, analysis of variance and log binomial generalized linear models as appropriate.DiscussionIt is necessary to restrict participants to Internet users to provide an appropriately controlled evaluation of PDS. Once efficacy of the approach has been established, it will be important to evaluate effectiveness in the wider at-risk population, and to identify barriers to its implementation in those settings.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000095066.

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Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

Publications

Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

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