Testing a Mammography Decision Intervention in a Rural Setting

Официальное название

Toward Optimization of a Mammography Decision Aid and Clinician Communication Intervention Trial for Rural Settings

Обзор

The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.

Подробное описание

This is a three-arm randomized pilot trial that will enroll 30 participants over two study phases. The main objective is to achieve data on trial feasibility (recruitment, retention, randomization, adherence, and acceptability). The primary outcome is Intervention Acceptability.

Procedures: PCPs will be randomized to one of the three arms to prevent contamination across patients (usual care, decision aid, decision aid + clinician communication). Patients will be considered for enrollment if they are aged 40-49, English or Spanish-speaking, have an upcoming primary care visit within 4 weeks, no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical hyperplasia, and no mammogram within the past 12 months. These patients will be identified via the electronic health record using routine data reports provided to the study team.

Data Collection: Surveys will be conducted at baseline (pre-intervention), post-DA and Post-Visit. Mammography screening information will be collected via medical records, and implementation data will be completed with patients and clinicians who were exposed to the decision aid intervention.

Analysis: All feasibility metrics will be summarized quantitatively, distributions examined for central tendency and spread, and all data assessed for completeness. Data will be presented in a tabular format, with means and standard deviations summarized for the Acceptability of Intervention Measure. Process data will likewise be summarized, reporting proportions of participants meeting each metric (recruitment, retention, randomization, adherence).

Вмешательства

• Поведенческое MyMammogram
  An online breast cancer screening decision aid
• Другое Provider communication
  Provider will be provided with information from MyMammogram that includes patient's breast cancer risk and preferences for mammograms prior to the appointment

Первичные конечные точки

• Intervention acceptability [Срок оценки: within one day of completing the intervention]

Вторичные конечные точки (2)

• Recruitment feasibility [Срок оценки: 4 weeks]
• Retention feasibility [Срок оценки: 8 weeks]

Критерии участия

Patient Inclusion Criteria:

• Females
• Aged 39-49
• Upcoming appointment with a participating primary care provider (within 4 weeks)
• English or Spanish-speaking

Patient Exclusion Criteria:

• Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)
• Mammogram in the prior 12 months

Clinician inclusion: Any practicing primary care provider at a participating site.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• Cheshire Medical Center — Keene
• New London Hospital Primary Care — New London
• Newport Health Center — Newport

Идентификаторы

NCT: NCT06522568 · STUDY02002381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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