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The overall goal of this study is to assess the implementation of the Ask Questions about Clinical Trials (ASQ-CT) brochure, a patient-focused communication tool previously demonstrated to improve patient-provider communication about clinical trials. Participants will be given the ASQ-CT brochure at Time 1 (baseline) and participants will complete a questionnaire at three timepoints, baseline (Time 1), Pre-Research Visit (Time 2), and Post-Research Visit (Time 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ask Questions about Clinical Trials (ASQ-CT) Brochure | Experimental | Ask Questions about Clinical Trials (ASQ-CT), a clinical trial communication intervention brochure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ask Questions about Clinical Trials brochure | Behavioral | Communication intervention called a question prompt list |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale | Improvement of self-efficacy in managing patient-providers interactions between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a better outcome | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Reach - Number and Proportion | Proportion of individuals invited to participate who agree to participate. The denominator will be the absolute number of individuals who are identified and approached as potential participants; the numerator will be the number of people who agreed to participate. Investigators will track the number of people who were excluded from participation and why. Investigators anticipate that reach will vary by research site and patient baseline characteristic (i.e., sociodemographic, health literacy level). These variations between clinics will be based only on consented participants. Although the Investigators will track refusals, data will not be collected from patients who decline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren M Hamel, PhD, MBA | Contact | 1-800-527-6266 | Lauren.Hamel@med.wayne.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren M Hamel, PhD, MBA | Wayne State University | Principal Investigator |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006331 | Heart Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| At start of Participation |
| Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale | Improvement of self-efficacy in managing patient-providers interactions between baseline (Time 2) and pre-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a better outcome | From Pre-Clinic (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months. |
| Effectiveness - Knowledge - Quantitative Scale | Improvement of knowledge between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a better outcome. | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) |
| Effectiveness - Knowledge - Quantitative Scale | Improvement of knowledge between pre-clinic visit (Time 2) and post-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a better outcome | From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months |
| Effectiveness - Trust - Quantitative Scale | Improvement in trust in providers between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a better outcome | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) |
| Effectiveness - Trust - Quantitative Scale | Improvement in trust in providers between pre-clinic visit (Time 2) and post-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a better outcome | From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months |
| Effectiveness - distress - Quantitative Scale | Improvement in distress between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a worse outcome. | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) |
| Effectiveness - distress - Quantitative Scale | Improvement in distress between pre-clinic visit (Time 2) and post-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a worse outcome. | From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months |
| Adoption - Number and Proportion | Adoption is defined by the number, proportion, and representativeness of the clinics willing to implement the Ask Questions about Clinical Trials (ASQ-CT) brochure. The denominator will be the absolute number of clinics who are invited to implement the ASQ-CT brochure; the numerator will be the number of clinics who agree to implement the ASQ-CT brochure. | At start of Participation |
| Implementation of the Intervention | Implementation is defined as intervention agents' (e.g., research/clinic staff) fidelity to the adaptations of the intervention and associated implementation strategies. Patients will receive the Ask Questions about Clinical Trials (ASQ-CT) brochure in Time 1. In Time 2, patients will be asked to respond to two fidelity (yes/no) questions, including: 1. When the participant received the ASQ-CT brochure, did the participant receive instructions on how to use it from the clinic/research staff (yes/no)? Was the participant given the chance to discuss the ASQ-CT brochure with clinic/research staff (yes/no?) | From Baseline (Time 1) to up to 3 months |