on-screen, point-of-care computer reminders on clinical practice.

No on-screen, point-of-care computer reminders on clinical practice.

computer reminders on clinical practice

Control group

Alessandro Passardi, MD

Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.

The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center

Objectives:

The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).

Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.

Short Title/Acronym ONCO-CODES Protocol Code IRST100.23

Rationale:

Computerized decision support systems (CDSSs) are computer programs that provide clinicians, staff, patients, or other individuals with person-specific, actionable recommendations or management options that are intelligently filtered or presented at appropriate times to enhance health and health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. The Investigators designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, point-of-care reminders generated by the Medilogy Decision Support System (MediDSS) on clinical practice and the quality of care in the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS. The Investigators hypothesize that MediDSS reminders can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to hospitalized patient. The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous calls for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians.

Study Design:

The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study Center(s) Single-center

Objectives:

The primary outcome of this trial is a process outcome. i.e. the rate at which the issues reported by the reminders are resolved (resolution rates).

Number of Subjects:

The investigators calculated the sample size on the basis of the primary outcome. A sample of 1,704 reminders will be necessary to detect the difference between the two groups (power = 0.90; α =0.05, two-sided; 1:1 allocation). Since estimates for intracluster correlation are not available, Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients.

Diagnosis and Main Inclusion Criteria:

The investigators will include all the patients admitted to the facilities of the IRST IRCCS. There are no exclusion criteria

Statistical Methodology:

All analyses will follow the intention-to-treat principle: patients will be analyzed in the group to which they have been randomized. Descriptive statistics will be presented.

All statistical tests will be two-sided. The investigators will use the Stata software to perform all statistical analyses (Stata Corp., College Station, TX, USA).The investigators increased the required sample size (by 20%) to 2,046 reminders to account for clustering by patient.

Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients

Effect on Professional Practice and Health Care Outcomes of Computerized Evidence-based Information System and Clinical Decision Support: A Randomized Controlled Trial in Orthopaedics (GR-2009-1606736)

the rate at which the issues reported by the reminders are resolved

Ministry of Health, Italy

University of Milan

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Catholic University of the Sacred Heart

Duodecim, Finnish Medical Association, Helsinki

Mario Negri Institute for Pharmacological Research

Ottawa Hospital Research Institute

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Website supporting informed patient decision making about prostate cancer care through tailored education and coaching

Personal Patient Profile - Prostate (P3P)

Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics

Standard prostate cancer information websites

Donna L Berry, PhD, RN

The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.

Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks

O'Connor, 1995, Decisional conflict scale

Graham and O'Connor, 1995, Preparation for decision making scale

Holmes-Rovner et al, 1996, Satisfaction with decision scale

Odds ratio of selecting a care option for prostate cancer concordant with avoiding prioritized side effects (XBRT or brachytherapy if concerned with sexual function; prostatectomy if concerned with bowel function; active surveillance if concerned with sexual, bowel, and/or bladder function; any treatment if not concerned with any side effect).

Cost to the patient will be measured in hours valued according to patient work status, income, and use of time. Benefit will be measured with Willingness to pay.

Duration (in days) from pre-decision baseline questionnaire until patient decides on a care option for prostate cancer, either an active treatment type or active surveillance. Measured by patient recall at 6-months.

National Institute of Nursing Research (NINR)

Dana-Farber Cancer Institute

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The intervention arm will receive full information on the risks and benefits of mammography through:

1. Decision aid
2. YouTube video
3. Group information session

Standard information leaflet for breast screening from Cancer Care Ontario

Patients will be randomized to receive full information or standard information at the study start. The second wave will follow the same randomization process 6 months following the study start.

Full information

Dee Mangin, MBChB, DPH, FRNZCGP

Jessica Langevin, MPH

Dee Mangin, MB ChB

Dale Guenter, MD

Cathy Risdon, MD

To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.

1:1 double-blinded randomized controlled trial of patients to receive the intervention or standard information (control) at the study start in an information package. The intervention includes a decision aid (previously developed by Hersch et al. 2015, with minor modifications to reflect the Canadian context), a YouTube video link and an invitation to attend a group information session. The intervention or standard information, depending on participants assigned study group, will be mailed or emailed to participants. The information packages will also include questionnaires to collect data on outcome measures. There will be two study waves to account for women's eligibility at different time points (i.e. when approaching a mammogram due date). The first wave of participants will receive their information package at the study start and the second wave of participants will be sent their information packages 6 months after the study start. Each wave of participants will be followed for one year. Data collection will include quantitative measures of factors relevant to the decision-making process. Screening participant rates will be measured for each wave of participants, 6 months and 12 months after their respective enrollment date. Qualitative methods will be used to obtain an understanding of clinician's perception of decision aids in a primary care setting. Outcome measures and analyses will be blinded.

Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)

Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial

Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.

Knowledge will be measured using the Multidimensional Measure of Informed Choice (MMIC).

Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.

Attitudes will be measured using the Multidimensional Measure of Informed Choice (MMIC).

Informed choice is comprised of knowledge, attitudes and intention/decisions. Informed choice will be measured using intention to screen at the first data collection point and screening participation at the second and third data collection point.

Intention to screen will be measured using a 5-point Likert scale.

SURE (Decisional Conflict Scale- SURE Test for clinical practice)

Women will be asked about their anxiety towards participating in breast screening after reading their information pamphlet using a 4-point Likert scale.

Women will be asked to assess their perception of the strength of the recommendation that their health care provider makes with respect to breast screening.

Women will be asked to describe the information that was relevant to their individual decision making process.

Data on a women's decision to undergo screening through mammography will be obtained from patient's electronic medical record.

Clinician staff will be asked to list the five best things and five worst things about the implementation of a patient focused decision aid.

Multiple choice question on knowledge of breast cancer mortality reduction and over-diagnosis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients	NCT02645357	Medical Oncolog...	computer remind... Control group	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks	NCT01844999	Prostate Cancer	Personal Patien... Standard prosta...	18 Years -	Dana-Farber Cancer Institute
Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)	NCT02914197	Breast Neoplasm	Full informatio...	47 Years - 69 Years	McMaster University
Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients	NCT02645357	Medical Oncolog...	computer remind... Control group	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for decision

Every month we try and update this database with for decision cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for decision

Every month we try and update this database with for decision cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for decision cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.