Involving Family to Improve Communication in Primary Care (SAMEPage)

• ClinicalTrials.gov Identifier: NCT02986958
• Recruitment Status: Completed
• First Posted: December 8, 2016
• Results First Posted: October 11, 2018
• Last Update Posted: December 31, 2018
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Johns Hopkins Community Physicians; Medstar Health Research Institute
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Health Services Research
• Condition: Cognitive Impairment
• Interventions: Other: Pre-visit patient-family agenda-setting checklist; Other: Usual care
• Enrollment: 93

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Checklist	Usual Care
Arm/Group Description	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	Care as usual with their primary care provider Usual care: routine primary care
Period Title: Overall Study
Started	49	44
Completed	49	44
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Checklist	Usual Care	Total
Arm/Group Description		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	Care as usual with their primary care provider Usual care: routine primary care	Total of all reporting groups
Overall Number of Baseline Participants		49	44	93
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	49 participants	44 participants	93 participants
		80.9 (8.0)	78.8 (7.1)	79.9 (7.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	49 participants	44 participants	93 participants
	Female	24 49.0%	24 54.5%	48 51.6%
	Male	25 51.0%	20 45.5%	45 48.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Nonwhite race or Hispanic ethnicity	Number Analyzed	49 participants	44 participants	93 participants
		18 36.7%	21 47.7%	39 41.9%
Mean Mini-Mental State Examination (MMSE) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	49 participants	44 participants	93 participants
		20.8 (7.8)	22.5 (5.5)	21.6 (6.8)
		[1] Measure Description: 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.

Outcome Measures

1. Primary Outcome

Title	Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)
Description	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.
Time Frame	During enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	44
Mean (Standard Error); Unit of Measure: Ratio
	0.86 (0.42)	0.68 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Checklist, Usual Care
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).
Statistical Test of Hypothesis	P-Value	0.046
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Visit Duration
Description	Duration of primary care visit in minutes
Time Frame	During enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	44
Mean (Standard Error); Unit of Measure: minutes
	25.5 (12.5)	24.8 (15.2)

3. Secondary Outcome

Title	Patient Verbal Activity
Description	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.
Time Frame	During enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	44
Mean (Standard Error); Unit of Measure: Proportion of visit statements
	.226 (0.14)	.271 (0.14)

4. Secondary Outcome

Title	Companion Verbal Activity
Description	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.
Time Frame	During enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	44
Mean (Standard Error); Unit of Measure: Proportion of visit statements
	.228 (0.14)	.182 (0.12)

5. Secondary Outcome

Title	Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit
Description	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.
Time Frame	During enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	44
Measure Type: Count of Participants; Unit of Measure: Participants
	17 34.7%	16 36.4%

6. Secondary Outcome

Title	Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
Description	The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Time Frame	During Enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	43	43
Measure Type: Count of Participants; Unit of Measure: Participants
	43 100.0%	43 100.0%

7. Secondary Outcome

Title	Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
Description	The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Time Frame	During Enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	44
Measure Type: Count of Participants; Unit of Measure: Participants
	49 100.0%	44 100.0%

8. Secondary Outcome

Title	Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
Description	The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Time Frame	During Enrollment visit, up to 77 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Checklist	Usual Care
Arm/Group Description:	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	Care as usual with their primary care provider Usual care: routine primary care
Overall Number of Participants Analyzed	49	43
Measure Type: Count of Participants; Unit of Measure: Participants
	46 93.9%	43 100.0%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Checklist	Usual Care
Arm/Group Description	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	Care as usual with their primary care provider Usual care: routine primary care
All-Cause Mortality
	Checklist	Usual Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/49 (0.00%)	0/44 (0.00%)
Serious Adverse Events
	Checklist	Usual Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/49 (0.00%)	0/44 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Checklist	Usual Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/49 (0.00%)	0/44 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Research Program Manager
• Organization: Johns Hopkins Bloomberg School of Public Health
• Phone: 410-614-7910
• EMail: dechava1@jhu.edu

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT02986958
• Other Study ID Numbers: R21AG049967 ( U.S. NIH Grant/Contract )
• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Results First Submitted: August 8, 2018
• Results First Posted: October 11, 2018
• Last Update Posted: December 31, 2018