Healthcare Cost-Effectiveness Trial

Healthcare Cost-Effectiveness Trial Consent and Enrollment Form

Study Identification

Participant Information

Date of Birth:   Gender:

Insurance Information

Medical History

Study Description and Purpose

You are being invited to participate in a trial that evaluates the comparative cost-effectiveness of treatments under study. The aim is to measure both clinical outcomes and the costs associated with those outcomes in order to inform clinical and policy decision-making. The study will collect clinical data, health care utilization, and cost-related information over a period of from the date of enrollment.

Procedures and Data Collection

If you agree to participate, you will be assigned to one of the study treatment arms as described by the investigator. Study procedures may include medical examinations, questionnaires, blood draws, and review of medical records. Data to be collected include clinical outcomes, laboratory results, health care encounters, and billing/claims data relating to services rendered.

Consent to specific data sources (check all that apply):
Electronic Health Record (EHR) access for treatment and utilization data
Health insurance claims data for cost and utilization
Telephone or electronic follow-up for patient-reported outcomes
Audio/video recording for procedure documentation (if applicable)

Risks, Benefits and Alternatives

The treatments in this study are already used in clinical care; participating may involve the same risks and benefits as receiving those treatments outside of the study. Additional risks specific to participation include time commitment, privacy risks associated with data sharing, and potential for unforeseen adverse events. There may be no direct benefit to you from participation. Alternatives include receiving standard clinical care outside the study.

I acknowledge that I have read and understood the risks and benefits described above and have had the opportunity to ask questions. I understand that my medical care will not be withheld if I decline participation.
I acknowledge the risks and benefits and wish to proceed with enrollment

Compensation and Costs

You will be informed of any compensation for participation and any costs that you may incur as a result of participation. Please indicate whether you have been provided compensation details and agree to them below.

Confidentiality, Data Use and HIPAA Authorization

To evaluate cost-effectiveness, the study will collect identifiable and de-identified data. Identifiable information will be used and disclosed only as described in this authorization. Data may be used for analysis, publication, and regulatory reporting in a manner that protects your identity to the extent required by law. Your authorization to use and disclose protected health information is voluntary and will not affect treatment, payment, or enrollment in other services.

I authorize the release of my protected health information to the study sponsor and their agents for the purposes described in this form, including review of medical records and linkage with claims or cost data.

Withdrawal and Questions

You may withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled. Withdrawal will not affect the use of data already collected prior to withdrawal where necessary to preserve the integrity of the study results, unless you specifically request otherwise in writing.

Consent and Certification

By signing below I certify that: I am at least 18 years of age (or otherwise legally authorized to consent); I have read and understand this consent form; the study procedures, risks, benefits, and alternatives have been explained to me; I have had the opportunity to ask questions and have received satisfactory answers; and I voluntarily agree to participate and to the use and disclosure of my health information as stated above.

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