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| Name | Class |
|---|---|
| Johns Hopkins Community Physicians | OTHER |
| Medstar Health Research Institute | OTHER |
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This study evaluates an agenda-setting checklist for patients with cognitive impairment and their family companions that is completed in the waiting room in advance of a primary care visit. The study team will conduct a two-group randomized trial to examine feasibility of the protocol and to compare medical communication (from visit audiotapes) during visits of patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who receive usual care (n=50)
The study team has established proof of concept for a paper-pencil checklist to be used by older patients and their companions in the waiting room prior to medical visits. The checklist is designed to elicit and align patient and companion perspectives regarding patient health issues to discuss with the doctor, and to stimulate discussion about the companion's role in the visit. The premise for the checklist is that companions are typically motivated to support patients during medical visits, but that they often lack knowledge of the patient's health concerns and preferences for communication assistance.
The study team will conduct a two group pilot randomized trial of up to 100 (50 per group) patients ages 65+ with cognitive impairment and their unpaid companion to test the effects of the refined checklist for medical communication. Each patient-companion dyad will be randomized to the intervention (to receive the checklist) or to a control protocol. The study will evaluate the feasibility of delivering the study protocol to patients with cognitive impairment and their companions in primary care, and to generate preliminary evidence regarding the effect of the checklist on medical communication. For these reasons, the control group protocol will comprise usual care which is in this case existing clinical practice. Patients (when feasible), companions, and doctors in both intervention and control groups will complete in-person post-visit surveys immediately after the visit. Patients (when feasible) and companions will separately complete follow-up surveys by telephone two weeks after the doctor visit conducted by a research staff member.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Checklist | Experimental | One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider |
|
| Usual Care | Placebo Comparator | Care as usual with their primary care provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-visit patient-family agenda-setting checklist | Other | Pre-visit patient-family agenda-setting checklist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) | Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication. | During enrollment visit, up to 77 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Visit Duration | Duration of primary care visit in minutes | During enrollment visit, up to 77 minutes |
| Patient Verbal Activity | Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Wolff, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Community Physicians | Aberdeen | Maryland | 21017 | United States | ||
| Medstar Center for Successful Aging |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24417565 | Background | Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13. | |
| 27817986 | Background | Wolff JL, Guan Y, Boyd CM, Vick J, Amjad H, Roth DL, Gitlin LN, Roter DL. Examining the context and helpfulness of family companion contributions to older adults' primary care visits. Patient Educ Couns. 2017 Mar;100(3):487-494. doi: 10.1016/j.pec.2016.10.022. Epub 2016 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Checklist | One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist |
| FG001 | Usual Care | Care as usual with their primary care provider Usual care: routine primary care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Checklist | One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) | Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication. | Posted | Mean | Standard Error | Ratio | During enrollment visit, up to 77 minutes |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Checklist | One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Program Manager | Johns Hopkins Bloomberg School of Public Health | 410-614-7910 | dechava1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2016 | Aug 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Usual care | Other | routine primary care |
|
| During enrollment visit, up to 77 minutes |
| Companion Verbal Activity | Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider. | During enrollment visit, up to 77 minutes |
| Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit | The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit. | During enrollment visit, up to 77 minutes |
| Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit." | During Enrollment visit, up to 77 minutes |
| Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit." | During Enrollment visit, up to 77 minutes |
| Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit." | During Enrollment visit, up to 77 minutes |
| Baltimore |
| Maryland |
| 21239 |
| United States |
| Johns Hopkins Community Physicians | Westminster | Maryland | 21157 | United States |
| 30022409 | Derived | Wolff JL, Roter DL, Boyd CM, Roth DL, Echavarria DM, Aufill J, Vick JB, Gitlin LN. Patient-Family Agenda Setting for Primary Care Patients with Cognitive Impairment: the SAME Page Trial. J Gen Intern Med. 2018 Sep;33(9):1478-1486. doi: 10.1007/s11606-018-4563-y. Epub 2018 Jul 18. |
| BG001 | Usual Care | Care as usual with their primary care provider Usual care: routine primary care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Mean Mini-Mental State Examination (MMSE) | The Mini-Mental State Examination (MMSE) is a 30-item questionnaire used to measure cognitive impairment in clinical and research settings. MMSE scores range from 0-30, with higher values indicating less impairment. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care | Care as usual with their primary care provider Usual care: routine primary care |
|
|
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| Secondary | Visit Duration | Duration of primary care visit in minutes | Posted | Mean | Standard Error | minutes | During enrollment visit, up to 77 minutes |
|
|
|
| Secondary | Patient Verbal Activity | Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider. | Posted | Mean | Standard Error | Proportion of visit statements | During enrollment visit, up to 77 minutes |
|
|
|
| Secondary | Companion Verbal Activity | Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider. | Posted | Mean | Standard Error | Proportion of visit statements | During enrollment visit, up to 77 minutes |
|
|
|
| Secondary | Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit | The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit. | Posted | Count of Participants | Participants | During enrollment visit, up to 77 minutes |
|
|
|
| Secondary | Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit." | The number of patient participants for this patient-reported outcome measure sums to 86 because 7 of the 93 total patient participants were too cognitively impaired to respond to the paper-pencil post-visit survey. | Posted | Count of Participants | Participants | During Enrollment visit, up to 77 minutes |
|
|
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| Secondary | Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit." | Posted | Count of Participants | Participants | During Enrollment visit, up to 77 minutes |
|
|
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| Secondary | Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit | The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit." | Posted | Count of Participants | Participants | During Enrollment visit, up to 77 minutes |
|
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Usual Care | Care as usual with their primary care provider Usual care: routine primary care | 0 | 44 | 0 | 44 | 0 | 44 |
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