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Abstract

Grant Number:	3R01AI042574-03S1
Project Title:	IMPROVING UNDERSTANDING IN EARLY PHASE CLINICAL TRIALS

PI Information:	Name	Email	Title
	KASS, NANCY E.	nkass@jhsph.edu	PROFESSOR

Abstract: DESCRIPTION (Adapted from the Investigator's Abstract): Despite descriptive work documenting that patients do not fully understand the nature of early phase clinical research, little work has been conducted testing interventions designed to enhance patients' understanding, a critical element of the informed consent process. Patient activation is an inexpensive intervention that has been used effectively in the health education arena, but has never been tested in early phase clinical trials. In the proposed study, patients eligible for early phase clinical trials in oncology and infectious disease clinics at the John Hopkins Hospital and Duke University Medical Center will be randomized either to receive or not receive a short, self-directed, computer-based educational intervention concerning the nature of clinical research before their appointment with the physician. In addition to describing the purpose of early phase trials, the intervention will include an "activation" component, meaning that questions will be suggested that patients might want to ask physician-investigators during their appointment. Discussions between physicians and patients will be audiotaped and analyzed using previously validated techniques to determine the effect of the intervention on doctor-patient interactions, including whether there are changes in the ratio of "doctor-speak" to "patient-speak" and in the amount of question asking by patients. Patients will be interviewed after these discussions, using quantitative and qualitative methods, to examine the degree to which the intervention and/or different styles of communication affect patient understanding, patients' expectation for personal medical benefit, patient enrollment, reasons for participating, patients' decisional commitment, satisfaction and trust in the process. Later in the study, aggregate feedback will be given to physician-investigators concerning what was learned in the analyses of physician-patient interactions and from patient interviews. The research may determine whether providing this simple feedback intervention to physician-investigators has an effect above and beyond any effect seen by providing an "activation" intervention to patients alone.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
clinical trial, computer assisted instruction, education evaluation /planning, health education, informed consent, patient professional relations
AIDS therapy, decision making, interview, neoplasm /cancer therapy
audiotape, clinical research, human subject

Institution:	JOHNS HOPKINS UNIVERSITY
	W400 Wyman Park Building
	BALTIMORE, MD 21218
Fiscal Year:	2000
Department:	HEALTH POLICY AND MANAGEMENT
Project Start:	30-SEP-1997
Project End:	29-SEP-2001
ICD:	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
IRG:	ZRG2

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