Dataset Information

The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial.

ABSTRACT: OBJECTIVE:The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. METHODS:A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. RESULTS:A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION:The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.

SUBMITTER: Berry DL

PROVIDER: S-EPMC3349002 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial.

Berry Donna L DL Halpenny Barbara B Hong Fangxin F Wolpin Seth S Lober William B WB Russell Kenneth J KJ Ellis William J WJ Govindarajulu Usha U Bosco Jaclyn J Davison B Joyce BJ Bennett Gerald G Terris Martha K MK Barsevick Andrea A Lin Daniel W DW Yang Claire C CC Swanson Greg G

Urologic oncology 20111207 7

<h4>Objective</h4>The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice.<h4>Methods</h4>A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or ...[more]

PMID: 22153756

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Project description:Men with localized prostate cancer often have unrealistic expectations. Practitioners are poor judges of men's preferences, contributing to preference misdiagnosis and unwarranted practice variation. Patient decision aids (PtDAs) can support men with decisions about localized prostate cancer. This is a comparative case study of two strategies for implementing PtDAs in clinical pathways for men with localized prostate cancer, evaluating (a) PtDA use; (b) impact on men, practitioners, and health system outcomes; and (c) factors influencing sustained use.Guided by the Knowledge to Action Framework, this comparative case study will be conducted using administrative data, interviews, and surveys. Cases will be bound by geographic location (one hospital in Ontario; province of Saskatchewan) and time. Eligible participants will be all men newly diagnosed with localized prostate cancer, with outcomes assessed using administrative data and interviews. Nurses, urologists, radiation oncologists, and managers will be surveyed and a smaller sample interviewed. Cases will be established for each setting with findings compared across cases. Changes in the proportions of men given the PtDA over 2 years will be determined from administrative data. Factors associated with receiving the PtDA will be explored using multivariable logistic regression analysis. To assess the impact of the PtDA, outcomes will be described using mean and standard deviation (men's decisional conflict) and frequency and proportions (practitioners consulted, uptake of treatment). To estimate the effect of the PtDA on these outcomes, adjusted mean differences and odds ratios will be calculated using exploratory multivariable general linear regression and binary or multinomial logistic regression. Factors influencing sustained PtDA use will be assessed using descriptive analysis of survey findings and thematic analysis of interview transcripts.Determining how to embed PtDAs effectively within clinical pathways for men with localized prostate cancer is essential. PtDAs have the potential to strengthen men's active role in making prostate cancer decisions, enhance uptake of shared decision-making by practitioners, and reduce practice variation. Our team of researchers and knowledge users will use findings to improve current PtDA use and consider scaling-up implementation.

Project description:IntroductionMen diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret.MethodsParticipants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms.ResultsAt 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others.ConclusionThe Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer.Trial registrationNCT01844999.

Project description:BackgroundMen diagnosed with localized prostate cancer (LPC) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important. The Personal Patient Profile-Prostate (P3P) is a computerized decision aid for men with LPC that focuses on personal preferences. We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group.MethodsEnglish/Spanish-speaking men diagnosed with LPC (2007-2009) from four US cities were enrolled into a randomized trial and followed through 6-months via mailed or online questionnaire. Men were randomized to receive the P3P intervention or standard education plus links to reputable websites. We classified choice as concordant if men were concerned with (a) sexual function and chose external beam radiotherapy or brachytherapy, (b) bowel function and chose prostatectomy, (c) sex, bowel, and/or bladder function and chose active surveillance, or (d) not concerned with any side effect and chose any treatment. Using logistic regression, we calculated odds ratios (OR) and 95% confidence intervals (CI) for the association between the P3P intervention and concordance.ResultsOf 448 men, most were <65 years, non-Hispanic white, had multiple physician consultations prior to enrollment, and chose a treatment discordant with concerns about potential side effects. There was no significant difference in concordance between the intervention (45%) and control (50%) group (OR = 0.82; 95%CI = 0.56, 1.2).ConclusionsThe P3P intervention did not improve concordance between potential side effects and treatment choice. Information and/or physician consultation immediately after diagnosis was likely to influence decisions despite concerns about side effects. The intervention may be more effective before the first treatment options consultation.Trial registrationNCT00692653 http://clinicaltrials.gov/ct2/show/NCT00692653.

Project description:BackgroundAlthough headache disorders are common, the current diagnostic approach is unsatisfactory. Previously, we designed a guideline-based clinical decision support system (CDSS 1.0) for diagnosing headache disorders. However, the system requires doctors to enter electronic information, which may limit widespread use.MethodsIn this study, we developed the updated CDSS 2.0, which handles clinical information acquisition via human-computer conversations conducted on personal mobile devices in an outpatient setting. We tested CDSS 2.0 at headache clinics in 16 hospitals in 14 provinces of China.ResultsOf the 653 patients recruited, 18.68% (122/652) were suspected by specialists to have secondary headaches. According to "red-flag" responses, all these participants were warned of potential secondary risks by CDSS 2.0. For the remaining 531 patients, we compared the diagnostic accuracy of assessments made using only electronic data firstly. In Comparison A, the system correctly recognized 115/129 (89.15%) cases of migraine without aura (MO), 32/32 (100%) cases of migraine with aura (MA), 10/10 (100%) cases of chronic migraine (CM), 77/95 (81.05%) cases of probable migraine (PM), 11/11 (100%) cases of infrequent episodic tension-type headache (iETTH), 36/45 (80.00%) cases of frequent episodic tension-type headache (fETTH), 23/25 (92.00%) cases of chronic tension-type headache (CTTH), 53/60 (88.33%) cases of probable tension-type headache (PTTH), 8/9 (88.89%) cases of cluster headache (CH), 5/5 (100%) cases of new daily persistent headache (NDPH), and 28/29 (96.55%) cases of medication overuse headache (MOH). In Comparison B, after combining outpatient medical records, the correct recognition rates of MO (76.03%), MA (96.15%), CM (90%), PM (75.29%), iETTH (88.89%), fETTH (72.73%), CTTH (95.65%), PTTH (79.66%), CH (77.78%), NDPH (80%), and MOH (84.85%) were still satisfactory. A patient satisfaction survey indicated that the conversational questionnaire was very well accepted, with high levels of satisfaction reported by 852 patients.ConclusionsThe CDSS 2.0 achieved high diagnostic accuracy for most primary and some secondary headaches. Human-computer conversation data were well integrated into the diagnostic process, and the system was well accepted by patients. The follow-up process and doctor-client interactions will be future areas of research for the development of CDSS for headaches.

Dataset Information

The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial.

Publications

The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial.

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