A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system

Abstract Background: Osteoarthritis (OA) is a health condition sensitive to patient’s preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care. Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients’ decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.Trial registration: ClinicalTrials.gob (NCT04241978). Registered on 24 January 2020.

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A shared decision-making tool for obstructive sleep apnea without tonsillar hypertrophy: A randomized controlled trial

The Laryngoscope ◽

10.1002/lary.26967 ◽

2017 ◽

Vol 128 (4) ◽

pp. 1007-1015 ◽

Cited By ~ 11

Author(s):

Mathieu Bergeron ◽

Angela L. Duggins ◽

Aliza P. Cohen ◽

Karin Tiemeyer ◽

Lisa Mullen ◽

...

Keyword(s):

Decision Making ◽

Randomized Controlled Trial ◽

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Controlled Trial ◽

Shared Decision ◽

Tonsillar Hypertrophy ◽

Randomized Controlled ◽

Obstructive Sleep ◽

Decision Making Tool

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Tailored Information About E-Cigarettes in a Web-Based Smoking Cessation Intervention: Study Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.27088 ◽

2021 ◽

Author(s):

Jan Mathis Elling ◽

Rik Crutzen ◽

Reinskje Talhout ◽

Hein de Vries

Keyword(s):

Decision Making ◽

Randomized Controlled Trial ◽

Smoking Cessation ◽

Study Protocol ◽

Controlled Trial ◽

Web Based ◽

Randomized Controlled ◽

Cessation Intervention ◽

Tailored Information ◽

Intervention Condition

BACKGROUND There is an ongoing debate whether or not electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers, because – despite this uncertainty – e-cigarettes are used by many smokers to reduce and/or quit tobacco smoking. OBJECTIVE To describe the study protocol of a Randomized Controlled Trial (RCT) to assess the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision-making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention. METHODS An RCT with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. Grounded on the I-Change Model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on six clusters of smoking cessation methods will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes; smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision-making (i.e., knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires. RESULTS Recruitment began in March 2020 and was completed by July 2020. We expect to publish the results in March 2021. CONCLUSIONS The experimental design of the study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision-making and smoking behavior. The findings can inform the development of future smoking cessation interventions. CLINICALTRIAL Dutch Trial Register, Trial NL8330 (https://www.trialregister.nl/trial/8330)

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Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/jmir.7449 ◽

2017 ◽

Vol 19 (9) ◽

pp. e312 ◽

Cited By ~ 14

Author(s):

Mirjam Pot ◽

Theo GWM Paulussen ◽

Robert AC Ruiter ◽

Iris Eekhout ◽

Hester E de Melker ◽

...

Keyword(s):

Decision Making ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Hpv Vaccination ◽

Decisional Conflict ◽

Future Research ◽

Tailored Intervention ◽

Web Based ◽

Vaccination Uptake ◽

Randomized Controlled

Background In 2010, the human papillomavirus (HPV) vaccination was introduced in the Dutch National Immunization Program for 12-year-old girls, aiming to reduce the incidence of cervical cancer in women. HPV vaccination uptake turned out to be lower than expected: 61% versus 70%, respectively. Mothers were shown to play the most important role in the immunization decision about this vaccination. They had also expressed their need for interactive personal information about the HPV vaccination over and above the existing universal general information. To improve the effectiveness of the existing education about the HPV vaccination, we systematically developed a Web-based tailored intervention with virtual assistants providing mothers of girls to be invited with tailored feedback on their decision making about the HPV vaccination. Objective The aim of this study was to evaluate the effectiveness of the Web-based tailored intervention for promoting HPV vaccination acceptance by means of a randomized controlled trial (RCT). Methods Mothers were recruited via the Dutch vaccination register (Praeventis) (n=36,000) and three Web-based panels (n=2483). Those who gave informed consent (N=8062) were randomly assigned to the control (n=4067) or intervention condition (n=3995). HPV vaccination uptake, as registered by Praeventis once the HPV vaccination round was completed, was used as the primary outcome. Secondary outcomes were differential scores across conditions between baseline (before the provided access to the new tailored intervention) and follow-up (just before the first vaccination) regarding the mothers’ degree of informed decision making (IDM), decisional conflict, and critical determinants of HPV vaccination uptake among which are intention, attitude, risk perception, and outcome beliefs. Results Intention-to-treat analysis (N=8062) showed a significant positive effect of the intervention on IDM, decisional conflict, and nearly all determinants of HPV vaccination uptake (P<.001). No effect was found on uptake (P=.60). This may be attributed to the overall high uptake rates in both conditions. Mothers evaluated the intervention as highly positive, including the website as well as the virtual assistants that were used to deliver the tailored feedback. Conclusions This computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls. Implications for future research are discussed. Trial Registration Trialregister.nl NTR4935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4935 (Archived by WebCite at http://www.webcitation.org/6srT7l9EM)

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The effectiveness of a digital shared decision-making tool in hormonal contraception during clinical assessment: study protocol of a randomized controlled trial in Spain

BMC Public Health ◽

10.1186/s12889-019-7572-9 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Maria Inmaculada de Molina-Férnandez ◽

Laia Raigal-Aran ◽

Miriam de la Flor-Lopez ◽

Paula Prata ◽

Isabel Font-Jimenez ◽

...

Keyword(s):

Decision Making ◽

Randomized Controlled Trial ◽

Shared Decision Making ◽

Clinical Assessment ◽

Controlled Trial ◽

Hormonal Contraception ◽

Shared Decision ◽

Randomized Controlled ◽

Assessment Study ◽

Decision Making Tool

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The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial

10.21203/rs.3.rs-18885/v1 ◽

2020 ◽

Author(s):

Lilisbeth Perestelo-Perez ◽

Yolanda Alvarez-Perez ◽

Amado Rivero-Santana ◽

Vanesa Ramos-García ◽

Andrea Duarte-Díaz ◽

...

Keyword(s):

Decision Making ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Options ◽

Hip Osteoarthritis ◽

Decision Making Process ◽

Web Based ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

The Impact

Abstract Background: Osteoarthritis (OA) is a health condition sensitive to patient’s preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care. Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients’ decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.Trial registration: ClinicalTrials.gob (NCT04241978). Registered on 24 January 2020.

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