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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG065311 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient: Conversation Aid On Mammography Screening | Participants will complete study procedures as follows:
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| Family: Conversation Aid On Mammography Screening | Caretakers/Family members to participants will complete study procedures as follows:
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| Clinician: Conversation Aid On Mammography Screening | Clinicians will complete study procedures as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mammography Screening Conversation Aid | Behavioral | 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. |
| 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. |
| 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. |
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Participant Inclusion Criteria:
Participant Family Members Inclusion Criteria:
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:
Participant Family Member Exclusion Criteria:
Primary Care Provider Exclusion Criteria:
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Primary care practices at Beth Israel Deaconess Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Mara Schonberg, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |