Health Communication, Health Literacy
Conditions
Keywords
AI literacy, AI communication
Brief summary
The objective of AI-CARE is to train researchers and community members to use artificial intelligence (AI) to create plain-language summaries of research studies and to determine whether a co-creation process for developing these summaries improves understanding and relevance of the research, confidence in AI and in institutions, and AI literacy. The hypothesis is that AI-generated research summaries, co-developed with researchers and community partners, will significantly improve confidence in research and institutions, understanding and accessibility of the research, and appropriateness of the summary compared with standard researcher-generated materials, and that the educational and co-creation process will build community members' AI literacy and confidence in using AI, as well as researchers' readiness to use and comfort with using AI for communicating research.
Detailed description
This research project consists of four specific aims. Specific Aims 2 and 3 meet the NIH definition of a clinical trial. Accordingly, this ClinicalTrials.gov registration describes only the clinical trial conducted under Specifics Aims 2 and 3. The remaining aims involve non-interventional research activities and are not included in this registration. Aims 2 and 3 are an intentional sequential design.
Interventions
BEHAVIORALCommunity co-created AI summaries
Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.
BEHAVIORALExperimental: Researcher prompt engineering
Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
BEHAVIORALExperimental: Standard AI prompt
Participants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.
BEHAVIORALAI literacy training and co-design
The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.
Sponsors
Albert Einstein College of Medicine
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Aim 2: N/A Aim 3: Participants are blinded to how the research summaries were developed. The summaries are presented in identical formats without identifying the development method. Study personnel performing the primary analyses remain blinded to treatment assignment until completion of the primary analyses.
Intervention model description
Aim 2: Single group: participants are prospectively assigned to an intervention (AI literacy training and co-design) to evaluate the effect of the intervention on health-related behavioral outcomes. Because only one response is allowed for allocation and number of participants, please note that allocation is N/A and number of participants is 40. Aim 3: Parallel: participants are randomized 1:1:1 to one of three summary types to compare the effect of the intervention on health-related behavioral outcomes. Because only one response is allowed for allocation and number of participants, please note that allocation is randomized, and number of participants is 210.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English-speaking individuals at least 18 years of age
Exclusion criteria
* Individuals unable to provide informed consent * Participants who have had formal training in AI prompt engineering The eligibility criteria are common to both Aims 2 and 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confidence in medical research and researchers - Aim 3 | Immediately following review of research summary, up to 1 hour | This is the primary outcome measure for both Aim 2 and Aim 3. This outcome measure will be assessed using subscale 1 of the PoRT scale. PoRT is a validated, self-report measure that assesses confidence in medical research and researchers. Subscale 1 contains 9 items, with response options for each item ranging from 1 (strongly disagree) to 5 (strongly agree); thus the subscale ranges from 9 to 45. Higher scores indicate higher confidence. |
| Confidence in medical research and researchers - Aim 2 | Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour | This is the primary outcome measure for both Aim 2 and Aim 3. This outcome measure will be assessed using subscale 1 of the PoRT scale. PoRT is a validated, self-report measure that assesses confidence in medical research and researchers. Subscale 1 contains 9 items, with response options for each item ranging from 1 (strongly disagree) to 5 (strongly agree); thus the subscale ranges from 9 to 45. Higher scores indicate higher confidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived appropriateness of research summary - Aim 2 | Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour | Perceived appropriateness of research summary will be assessed using an 8-item scale adapted from the literature which measures community and personal relevance, fit and respect, language and representation, and confidence and resonance (each of the four constructs is measured using two items). Responses for the eight items range from 1=strongly disagree to 5=strongly agree; possible scale score thus ranges from 8 to 40. Higher scores indicate higher perceived appropriateness. |
| Institutional confidence - Aim 2 | Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour | This is a validated measure of confidence in health care institutions, assessed using the MMI scale which contains 7 items. Responses range from 1 (strongly disagree) to 5 (strongly agree); thus, the range of scale scores is 7 to 35. Lower scores indicate higher confidence. |
| Research comprehension - Aim 2 | Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour | Research study specific comprehension which will consist of 25 true-false statements (5 items for each of the 5 research studies chosen by researchers and community participants that will be used for creation of plain-language summaries). Correct answers = 1, and incorrect answers = 0. The range will be 0 to 25, with higher scores indicating better comprehension. |
| Perceived appropriateness of research summary - Aim 3 | Immediately following review of research summary, up to 1 hour | Perceived appropriateness of research summary will be assessed using an 8-item scale adapted from the literature which measures community and personal relevance, fit and respect, language and representation, and confidence and resonance (each of the four constructs is measured using two items). Responses for the eight items range from 1=strongly disagree to 5=strongly agree; possible scale score thus ranges from 8 to 40. Higher scores indicate higher perceived appropriateness. |
| Institutional confidence - Aim 3 | Aim 3: Immediately following review of research summary, up to 1 hour | This is a validated measure of confidence in health care institutions, assessed using the MMI scale which contains 7 items. Responses range from 1 (strongly disagree) to 5 (strongly agree); thus, the range of scale scores is 7 to 35. Lower scores indicate higher confidence. |
| Research comprehension - Aim 3 | Immediately following review of research summary, up to 1 hour | Research study specific comprehension which will consist of 25 true-false statements (5 items for each of the 5 research studies chosen by researchers and community participants that will be used for creation of plain-language summaries). Correct answers = 1, and incorrect answers = 0. The range will be 0 to 25, with higher scores indicating better comprehension. |
Countries
United States
Contacts
CONTACTJessica Kahn, MD, MPH
PRINCIPAL_INVESTIGATORJessica Kahn, MD, MPH
Albert Einstein College of Medicine
Outcome results
None listed