An interventional study of Community co-created AI summaries and Experimental: Researcher prompt engineering in Health Literacy and Health Communication, sponsored by Albert Einstein College of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Other
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.
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.
201 studies on the registry are indexed under Literacy; 69 are open to participants now.
This study's planned enrollment of 250 is above the median of 124 across 170 interventional studies indexed under Literacy.
Browse Literacy studies →Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.
Compared within Literacy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Communication. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The eligibility criteria are common to both Aims 2 and 3.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.
Behavioral: Experimental: Standard AI prompt
Participants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
Behavioral: Experimental: Researcher prompt engineering
Participants receive summaries developed through an iterative community-researcher co-creation process following AI training and structured co-design sessions.
Behavioral: Community co-created AI summaries
Participants will be divided into three groups, each assigned 1-2 research summaries, and will engage in structured co-creation sessions. The goals of will be to: 1) define readability and appropriateness, 2) review AI-generated drafts produced by the summary engine, and 3) provide feedback to refine prompts and outputs. Several iteration cycles will be conducted as needed, with documentation of any changes and the rationale for making decisions. In this way the team will develop a modular AI "summary engine" that transforms research products (e.g., manuscripts) into draft community-facing materials using co-created prompts and templates. Co-creation will be conducted during one or two facilitated sessions. Each session will include structured review of drafts, guided discussion, and documented decisions regarding readability, transparency, visuals or graphics, etc. Iteration cycles will continue until pre-specified stopping criteria are met.
Behavioral: AI literacy training and co-design
Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.
Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
Participants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.
The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.
Confidence in medical research and researchers - Aim 3
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.
Time frame: Immediately following review of research summary, up to 1 hour
Confidence in medical research and researchers - Aim 2
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.
Time frame: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Perceived appropriateness of research summary - Aim 2
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.
Time frame: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Institutional confidence - Aim 2
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.
Time frame: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Research comprehension - Aim 2
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.
Time frame: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Perceived appropriateness of research summary - Aim 3
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.
Time frame: Immediately following review of research summary, up to 1 hour
Institutional confidence - Aim 3
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.
Time frame: Aim 3: Immediately following review of research summary, up to 1 hour
Research comprehension - Aim 3
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.
Time frame: Immediately following review of research summary, up to 1 hour
Plan to share: No — A data management and sharing plan was not created for this grant.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Albert Einstein College of Medicine →