Cardiac Disease, Neurologic Disorder, Oncology
Conditions
Brief summary
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).
Interventions
BEHAVIORALAsk Questions about Clinical Trials brochure
Communication intervention called a question prompt list
Sponsors
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or equal to 18 years * Appointment to see a provider at a Karmanos Cancer Institute-McLaren or a medical encounter at McLaren Center for Research and Innovation (MCRI) site for medical/systemic treatment * Potentially eligible for a clinical trial * Speak and read English well enough to be able to understand consent documents and complete surveys
Exclusion criteria
* Not able to complete study documents on their own physically or cognitively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach - Number and Proportion | At start of Participation | 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. |
| Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale | From Pre-Clinic (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months. | 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 |
| Effectiveness - Knowledge - Quantitative Scale | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) | 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. |
| Effectiveness - Trust - Quantitative Scale | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) | 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 |
| Effectiveness - distress - Quantitative Scale | From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2) | 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. |
| Adoption - Number and Proportion | At start of Participation | 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. |
| Implementation of the Intervention | From Baseline (Time 1) to up to 3 months | 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?) |
Countries
United States
Contacts
CONTACTLauren M Hamel, PhD, MBA
PRINCIPAL_INVESTIGATORLauren M Hamel, PhD, MBA
Wayne State University
Outcome results
None listed