Testing Conversation Aid in Practice

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing a Conversation Aid on Mammography Screening for Clinicians and Women 75 and Older in Practice

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Mammography Screening Conversation Aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient: Conversation Aid On Mammography Screening<br>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. | Behavioral: Mammography Screening Conversation Aid<br>* 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.<br>|
| Family: Conversation Aid On Mammography Screening<br>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. | Behavioral: Mammography Screening Conversation Aid<br>* 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.<br>|
| Clinician: Conversation Aid On Mammography Screening<br>Clinicians will complete study procedures as follows: Pretest questionnaires. Post-test questionnaires. | Behavioral: Mammography Screening Conversation Aid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months. | 
| Mammogram Attitudes Questionnaire | Assessed by the mammogram attitudes questionnaire, comprised of 3 questions graded on a 7-point Likert scale with answers ranging from 1 Completely Unnecessary/Harmful/Unpleasant to 7 Completely Necessary/Beneficial/Pleasant. Scores will be summed and a total score will range from 3 - 21. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months. | 
| Mammogram Perceived Norms Questionnaire | Assessed by the mammogram norms questionnaire, comprised of 2 questions graded on a 7-point Likert scale with answers ranging from 1 Strongly Disagree to 7 Strongly Agree. Scores will be summed and a total score will range from 2 - 14. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months. | 
| Clinician Self-Efficacy Scale | Assessed by the clinician self-efficacy subscale of the Shared Decision Making (SDM) Questionnaire, which measures clinician self-efficacy to engage older women in shared decision making around mammography screening and is comprised of 5 questions graded on a 7-point Likert scale with answers ranging from 1 Strongly Disagree/Easy to 7 Strongly Agree/Difficult. A total score will range from 5 to 35. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months. | 
| Clinician Attitudes Scale | Assessed by the clinician attitudes Subscale of the Share Decision Making (SDM Questionnaire which is comprised of 4 questions about clinician attitudes towards mammography screening and graded on a 7-point Likert scale with scores ranging from 1 Unnecessary/Harmful/Unpleasant/Worthless to 7 Necessary/Beneficial/Pleasant/Useful. A total score will range from 4 - 28. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months. | 
| Clinician Perceived Norms Scale | Assessed by the clinician perceived norms subscale of the Shared Decision Making (SDM) Questionnaire which is comprised of 4 questions about clinician perceived norms around mammography screening and graded on a 7-point Likert scale with answers ranging from 1 Strongly Disagree to 7 Strongly Agree. A total score will range from 4 - 28. | 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Mammography, Breast Cancer Screening, Mammography Screening