Testing a Conversation Aid on Mammography Screening for Clinicians and Women 75 and Older in Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Intentions For Screening Questionnaire
研究概览
简要总结
The goal of this research study is to develop and test a website to help primary care providers (PCPs) discuss the pros and cons of mammography with women aged 75 and older and to help participants make decisions about mammography.
详细描述
This research study is to conduct a pilot pretest-posttest trial to learn if providing a web-based conversation aid (CA) on mammography screening to 36 primary care providers facilitates shared decision making (SDM) and 8 medical assistants with 190 of their patients (2-3 per PCP) aged 75-89 years and 23 involved family members.
Research procedures include screening for eligibility, questionnaires, and clinic visits.
Participation in this research study is expected to last about 4 months.
It is expected about 90 participants, 23 participant family members, 36 primary care providers, and 8 medical assistants will participant in this research study.
The National Institute on Aging is supporting this research study by providing funding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 89 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant Inclusion Criteria:
- •English-speaking
- •Aged 75 - 89 years
- •Seen by an attending-level (non-resident) seen at the recruitment practices who have the -Ability and willingness to provide verbal consent.
- •Participant Family Members Inclusion Criteria:
- •Family member of patient that has agreed to participate in the study
- •English speaking
- •Ability and willingness to provide verbal consent
- •Primary Care Provider Inclusion Criteria:
- •Non-resident physician, nurse practitioner, or physician assistant
- •>18 years old
- •English speaking
- •Cares for a panel of patients that includes women >75 years at one of the recruitment practices
- •Ability and willingness to provide verbal consent
- •Participant
排除标准
- •Last mammogram <6 or >30 months (so that participants may be contemplative of their next mammogram)
- •History of dementia
- •Incapacity for informed consent
- •History of invasive or non-invasive breast cancer
- •Last mammogram was abnormal
- •Non-English speaking
- •Already chose to stop being screened (documented in medical records or scores of 1-3 [do not intend to be screened] on a validate 15 point intentions to be screened scale.)
- •PCP unwilling to have patient participate
- •In hospice
- •PCP not willing to participate
- •Psychiatric illness situations that would limit compliance with study requirements
- •Participant Family Member Exclusion Criteria:
- •Non-English speaking
- •Psychiatric illness situations that would limit compliance with study requirements
- •Primary Care Provider Exclusion Criteria:
- •Resident physician
- •Psychiatric illness situations that would limit compliance with study requirements
研究组 & 干预措施
Patient: Conversation Aid On Mammography Screening
Participants will complete study procedures as follows:
- Pretest questionnaires.
- PCP Appointment with introduction to conversation aid website.
- Post-test questionnaires within two weeks of PCP visit.
干预措施: Mammography Screening Conversation Aid (Behavioral)
Family: Conversation Aid On Mammography Screening
Caretakers/Family members to participants will complete study procedures as follows:
- Pretest questionnaires.
- Attend with participant PCP Appointment with introduction to conversation aid website.
- Post-test questionnaires within two weeks of PCP visit.
干预措施: Mammography Screening Conversation Aid (Behavioral)
Clinician: Conversation Aid On Mammography Screening
Clinicians will complete study procedures as follows:
- Pretest questionnaires.
- Post-test questionnaires.
干预措施: Mammography Screening Conversation Aid (Behavioral)
结局指标
主要结局
Intentions For Screening Questionnaire
时间窗: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Assessed by the Intentions for Screening questionnaire, a 15-point validated measure (1 to 15) to assess one's leaning towards an option with scores of 1=no, 8= unsure, and 15=yes.
次要结局
- Shared Decision Making (SDM) Questionnaire(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.)
- Mammogram Perceived Norms Questionnaire(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.)
- Role In Decision (Decision Making Preferences Questionnaire)(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.)
- Participant Knowledge Questionnaire(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.)
- Clinician Self-Efficacy Scale(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.)
- Decisional Conflict Questionnaire(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.)
- Mammogram Attitudes Questionnaire(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.)
- Clinician Perceived Norms Scale(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.)
- Clinician Attitudes Scale(1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.)
研究者
Mara Schonberg
Principal Investigator
Beth Israel Deaconess Medical Center