Testing Conversation Aid in Practice

Beth Israel Deaconess Medical Center155 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Breast Cancer

Interventions

Mammography Screening Conversation AidBEHAVIORAL

Web-based, "Decide Together" conversation aid designed to be used by PCP and participant for shared decision making and to provide information on the benefits and harms of mammography screening as well as educational talking points.

Eligibility

Sex: FEMALEMin age: 75 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Intentions For Screening Questionnaire

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.

Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

Secondary Outcomes

Shared Decision Making (SDM) Questionnaire

Assessed by the validated, 9-item SDM questionnaire. Each item will be scored on a 6-point Likert scale with answers ranging from 0 "completely disagree" to 6 "completely agree." A total score will range from 9 - 54.

Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

Decisional Conflict Questionnaire

Assessed by the Decisional Conflict Questionnaire, a validated, 16 item scale scored on a 5-point Likert scale. Answers range from 1 "Strongly Agree" to 0 "Neutral" to 4 " Strongly Agree" with each score ranging from 0 - 4 points. A total is calculated by \[sum of scores/16\] x 25=scale 0-100).

Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

Role In Decision (Decision Making Preferences Questionnaire)

Controlled preferences scale Assessed by the Decision Making Preferences questionnaire which includes 5 response categories (see comments). We will group the 5-items into 3 categories (patient prefers to make the decision, patient prefers the PCP makes the final decision, the patient prefers to share the decision with the PCP). This scale is commonly used to assess a participant's preferred involvement in decision making.

Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

Participant Knowledge Questionnaire

Assessed by the participant knowledge questionnaire, comprised of 10 True/False questions. Total score will be reported as a mean percentage of the number of questions answered correctly.

Data from ClinicalTrials.gov

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