Africa, Algorithms, Biomarker, Clinical Decision Support Systems, Community Health Services, Evidence-Based Practice, Global Health, Implementation Research, Models, Nigeria, Predictive Value of Tests, Primary Health Care, Prostate Cancer, Prostate Specific Antigen, Risk Assessment
Conditions
Keywords
Prostate cancer, early detection, prostate cancer screening, early diagnosis, prostate specific antigen, risk calculator, risk prediction model, diagnostic accuracy, validation, prostate biopsy, primary care, implementation science, Africa, precision prevention, clinically significant prostate cancer, clinical prediction model, community oncology, Nigeria
Brief summary
This study is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk population. The main questions the validation study aims to answer are: 1. How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer? 2. Will a new risk calculator designed for Nigerian men more accurately identify those with clinically significant prostate cancer? The main questions the intervention study aims to answer is: Will the primary care provider-facing risk calculator be feasible and acceptable for primary care providers to implement? The intervention trial will be piloted among participants in community-level hospitals in order to primarily assess implementation outcomes
Detailed description
The validation study will use prospective data from 500 participants with suspicion of prostate cancer to compare the effectiveness of prostate cancer risk calculator(s). The intervention study is the only specific aim that meets the definition of a Clinical Trial. This clinicaltrial.gov information is based on the intervention study. 1. For training, healthcare practitioners from community-level hospitals will be invited to participate. Before the training, a pre-test questionnaire will be given to conveniently sampled attending participants. After the training, the same questionnaire will be given to the same participants. The pre- and post-training knowledge scores will be compared to see if there is a change in knowledge. 2. Supported risk assessment with the risk calculator will be piloted for at least six months. Primary care providers at community-level hospitals will use the online risk calculator to assess prostate cancer risk in patient participants 40-79 years old who are accessing their services. After the risk assessment, we will evaluate feasibility and acceptability using a mixed methods approach.
Interventions
OTHER(a) Training and (b) Supported risk assessment
1. The training intervention will be facilitated by experienced clinical mentors through didactics and demonstrations and conducted as half-day sessions over 3 days 2. This intervention includes risk calculator use and clinical mentorship for at least six months.
Sponsors
Ahmadu Bello University
Fogarty International Center of the National Institute of Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
1. Pre-post design for the training intervention (25 participants) 2. Pilot trial for the risk calculator implementation (64 participants)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals. 2. Supported Risk Assessment (i) Eligible key informants will be eligible primary care providers who were trained and implemented the supported risk assessment and the targeted population of patient participants who received the supported risk assessment. (ii) Eligible patient participants (for the collection of observation data) will be the target population of adult males 40 - 79 years accessing provider services.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Task completion rate | 6 months | The percentage of risk calculator tasks successfully completed by providers during the risk assessment of patient participants. A task will be be considered successfully completed if all required steps are performed. Task completion will be documented using a standardized activity checklist and summarized using descriptive statistics. |
| Perceived feasibility of risk calculator use | 6 months | Feasibility will be assessed through participants' perceptions of the suitability of the risk calculator for its intended clinical purpose and its fit within routine clinical workflow. Data will be collected through qualitative feedback interviews and analyzed using thematic analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of risk calculator use | 6 months | Acceptability will be assessed through participants' perceptions of the content relevance and perceived complexity of the risk calculator for clinical decision-making. Data will be collected through qualitative feedback interviews and analyzed using thematic analysis. |
| Change in knowledge score following training | 3 days | Knowledge will be assessed using a structured questionnaire administered before and after training. Each questionnaire item will be scored as 1 for a correct response and 0 for an incorrect response. The total knowledge score will be calculated as the sum of correct responses. The change in knowledge score from pre-training to post-training assessment will be analyzed using inferential statistics. |
Countries
Nigeria
Contacts
CONTACTMusliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
Outcome results
None listed