Clinical trial NCT06011434: Testing Conversation Aid in Practice
Official title: Testing a Conversation Aid on Mammography Screening for Clinicians and Women 75 and Older in Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Mammography
Breast Cancer Screening
Mammography Screening
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-25
Enrollment: 157
Sex: FEMALE
Minimum age (years): 75
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care practices at Beth Israel Deaconess Medical Center

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Intentions For Screening Questionnaire
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Secondary outcomes:
measure: Shared Decision Making (SDM) Questionnaire
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
measure: Decisional Conflict Questionnaire
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
measure: Role In Decision (Decision Making Preferences Questionnaire)
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
measure: Participant Knowledge Questionnaire
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
measure: Mammogram Attitudes Questionnaire
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
measure: Mammogram Perceived Norms Questionnaire
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
measure: Clinician Self-Efficacy Scale
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
measure: Clinician Attitudes Scale
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
measure: Clinician Perceived Norms Scale
timeFrame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mara Schonberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: