Testing Conversation Aid in Practice

Beth Israel Lahey Health

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Mammography Screening Conversation Aid

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06011434

23-201

R01AG065311 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 157 estimated patients

Sex: Female

Ages: 75 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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
• Age >18
• 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 Exclusion Criteria:

• 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:

• Age <18
• 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

Trial design

157 participants in 3 patient groups

Patient: Conversation Aid On Mammography Screening

Description:

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.

Treatment:

Behavioral: Mammography Screening Conversation Aid

Family: Conversation Aid On Mammography Screening

Description:

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.

Treatment:

Behavioral: Mammography Screening Conversation Aid

Clinician: Conversation Aid On Mammography Screening

Description:

Clinicians will complete study procedures as follows: * Pretest questionnaires. * Post-test questionnaires.

Treatment:

Behavioral: Mammography Screening Conversation Aid