Trial Outcomes & Findings for A Family-centered Intervention for Acutely-ill Persons With Dementia (NCT NCT03046121)

Last Updated: 2024-06-06

Results Overview

Assessed using the Barthel Index, comparing the change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge. Return to baseline physical function (yes/no) was scored as yes if the participant's functional status was the same as baseline, within five points or less than baseline, or greater than baseline. Scores ranged from 0 to 1, with higher scores representing better outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

461 participants

Primary outcome timeframe

Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge

Results posted on

2024-06-06

Participant Flow

Recruitment was conducted between November 2017-July 2021 in six medical units across three hospitals.

Unit of analysis: hospital units

Participant milestones

Participant milestones
Measure	Fam-FFC The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Overall Study STARTED	229 3	232 3
Overall Study Hospital 1	89 1	86 1
Overall Study Hospital 2	73 1	73 1
Overall Study Hospital 3	67 1	73 1
Overall Study COMPLETED	183 3	160 3
Overall Study NOT COMPLETED	46 0	72 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Fam-FFC The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Overall Study Death	32	60
Overall Study Withdrawal by Subject	14	12

Baseline Characteristics

Row population differs from the overall population due to attrition, which includes participants who have died, withdrawn, or were unavailable.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). Admission	0.68 units on a scale Standard Error 0.12	0.76 units on a scale Standard Error 0.10
Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). Discharge	0.77 units on a scale Standard Error 0.10	0.73 units on a scale Standard Error 0.11
Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). 2-months post discharge	0.77 units on a scale Standard Error 0.10	0.61 units on a scale Standard Error 0.13
Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). 6-months post-discharge	0.66 units on a scale Standard Error 0.12	0.53 units on a scale Standard Error 0.14

PRIMARY outcome

Timeframe: Discharge and 2 and 6 months post-discharge

Assessed by the Preparedness for Caregiving Scale with scores ranging from 0 to 4 and higher scores indicating greater perceived preparedness.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Caregiver Preparedness Discharge	23.7 score on a scale Standard Deviation 6.65	23.9 score on a scale Standard Deviation 6.93
Caregiver Preparedness 2 months post-discharge	24.1 score on a scale Standard Deviation 6.58	25.0 score on a scale Standard Deviation 6.38
Caregiver Preparedness 6 months post-discharge	26.5 score on a scale Standard Deviation 6.83	26.2 score on a scale Standard Deviation 6.63

SECONDARY outcome

Timeframe: Admission, Discharge, 2 and 6 months post-discharge

Assessed by the Confusion Assessment Method Short Form with scores ranging from 0-7 and higher scores indicating more delirium severity.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Delirium Severity Admission	1.6 score on a scale Standard Deviation 1.71	1.3 score on a scale Standard Deviation 1.65
Delirium Severity Discharge	1.0 score on a scale Standard Deviation 1.51	1.0 score on a scale Standard Deviation 1.43
Delirium Severity 2 month post-discharge	.98 score on a scale Standard Deviation 1.46	1.0 score on a scale Standard Deviation 1.44
Delirium Severity 6 months post-discharge	1.1 score on a scale Standard Deviation 1.57	1.0 score on a scale Standard Deviation 1.46

SECONDARY outcome

Timeframe: Admission, Discharge, 2 and 6 months post-discharge

Assessed by the Brief Neuropsychiatric Inventory with scores ranging from 0 to 36 and higher scores indicating greater behavioral and psychological symptoms of dementia.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Behavior Admission	8.4 score on a scale Standard Deviation 6.60	7.2 score on a scale Standard Deviation 5.55
Behavior Discharge	6.5 score on a scale Standard Deviation 6.07	6.3 score on a scale Standard Deviation 5.81
Behavior 2 months post-discharge	5.3 score on a scale Standard Deviation 6.03	5.4 score on a scale Standard Deviation 5.79
Behavior 6 months post-discharge	5.5 score on a scale Standard Deviation 6.24	4.6 score on a scale Standard Deviation 5.56

SECONDARY outcome

Timeframe: admission, discharge, 2 and 6 months post-discharge

Actigraphy data, measured by the MotionWatch 8, includes minutes spent in moderate activity.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Moderate Physical Activity Level Admission	4.8 minutes Standard Deviation 14.11	8.3 minutes Standard Deviation 29.35
Moderate Physical Activity Level Discharge	14.2 minutes Standard Deviation 42.20	19.1 minutes Standard Deviation 48.86
Moderate Physical Activity Level 2 months post-discharge	23.3 minutes Standard Deviation 51.65	29.9 minutes Standard Deviation 63.07
Moderate Physical Activity Level 6 months post-discharge	27.3 minutes Standard Deviation 41.86	24.88 minutes Standard Deviation 43.26

SECONDARY outcome

Timeframe: admission, discharge, 2 and 6 months post-discharge

Assessed by the Cornell Scale for Depression in Dementia with total scores ranging between 0 to 38 and higher scores indicate more depressive symptoms.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Depression Admission	9.4 score on a scale Standard Deviation 6.70	9.0 score on a scale Standard Deviation 5.72
Depression Discharge	7.5 score on a scale Standard Deviation 6.19	7.4 score on a scale Standard Deviation 6.02
Depression 2 months post-discharge	6.2 score on a scale Standard Deviation 6.05	6.6 score on a scale Standard Deviation 5.95
Depression 6 months post-discharge	6.2 score on a scale Standard Deviation 6.74	5.01 score on a scale Standard Deviation 5.44

SECONDARY outcome

Timeframe: Discharge and 2 and 6 months post-discharge

Assessed by the Modified Caregiver Strain Index with total scores ranging from 0 to 26 and higher scores indicating greater caregiver strain.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Caregiver Strain Discharge	8.1 score on a scale Standard Deviation 6.53	7.9 score on a scale Standard Deviation 6.63
Caregiver Strain 2 months post-discharge	8.1 score on a scale Standard Deviation 7.02	7.2 score on a scale Standard Deviation 6.90
Caregiver Strain 6 months post-discharge	6.9 score on a scale Standard Deviation 6.83	6.5 score on a scale Standard Deviation 6.32

SECONDARY outcome

Timeframe: Discharge and 2 and 6 months post discharge.

Assessed using the Short Form Zarit Burden Interview with total scores total scores ranging from 0 to 48, with higher scores corresponding to higher levels of caregiver burden.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Caregiver Burden Discharge	10.0 score on a scale Standard Deviation 9.02	9.7 score on a scale Standard Deviation 9.79
Caregiver Burden 2 months post-discharge	13.5 score on a scale Standard Deviation 10.05	12.7 score on a scale Standard Deviation 9.88
Caregiver Burden 6 months post-discharge	9.0 score on a scale Standard Deviation 10.64	7.7 score on a scale Standard Deviation 9.26

SECONDARY outcome

Timeframe: Discharge and 2 and 6 months

Assessed by the Hospital Anxiety and Depression subscale with total scores ranging from 0 to 21 and higher scores indicating greater levels of caregiver anxiety.

Outcome measures

Outcome measures
Measure	Fam-FFC n=229 Participants The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=232 Participants Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Caregiver Anxiety 2 months post-discharge	4.7 score on a scale Standard Deviation 4.78	4.5 score on a scale Standard Deviation 4.76
Caregiver Anxiety Discharge	5.4 score on a scale Standard Deviation 4.79	5.2 score on a scale Standard Deviation 4.72
Caregiver Anxiety 6 months post-discharge	4.7 score on a scale Standard Deviation 4.94	4.3 score on a scale Standard Deviation 4.91

SECONDARY outcome

Timeframe: discharge and 2 and 6 months

Number of falls a week after hospital discharge and 2 and 6 months post discharge.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Falls Discharge	.15 Falls Standard Deviation .55	.14 Falls Standard Deviation .66
Falls 2 months post-discharge	.52 Falls Standard Deviation 1.52	.41 Falls Standard Deviation 1.19
Falls 6 months post-discharge	.76 Falls Standard Deviation 2.71	.57 Falls Standard Deviation 2.17

SECONDARY outcome

Timeframe: discharge and 2 and 6 months

Number of hospitalizations within a week after discharge; number of hospitalizations between discharge to 2 months post-discharge; number of hospitalizations between 2 months post-discharge and 6 months post-discharge.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Hospitalizations Discharge	.05 Hospitalizations Standard Deviation .22	.10 Hospitalizations Standard Deviation .31
Hospitalizations 2 months post-discharge	.33 Hospitalizations Standard Deviation .73	.41 Hospitalizations Standard Deviation .98
Hospitalizations 6 months post-discharge	.32 Hospitalizations Standard Deviation .86	.33 Hospitalizations Standard Deviation .77

SECONDARY outcome

Timeframe: discharge and 2 and 6 months

Number of ER visits within a week after discharge; number of ER visits between discharge to 2 months post-discharge; number of ER visits between 2 months post-discharge and 6 months post-discharge.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) n=3 hospital units Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Emergency Room (ER) Visits 2 months post-discharge	.41 Emergency room visits Standard Deviation .80	.44 Emergency room visits Standard Deviation 1.02
Emergency Room (ER) Visits Discharge	.06 Emergency room visits Standard Deviation .23	.08 Emergency room visits Standard Deviation .29
Emergency Room (ER) Visits 6 months post-discharge	.46 Emergency room visits Standard Deviation .97	.35 Emergency room visits Standard Deviation .71

OTHER_PRE_SPECIFIED outcome

Timeframe: end of intervention at each study site, 12 months after enrollment initiated

Population: Only participants in the Fam-FFC intervention group were measured and analyzed (i.e., contributed data reported in the table) and were included in the overall number of participants analyzed.

cost equals staff and research nurse time (hours worked and training time) to conduct intervention.

Outcome measures

Outcome measures
Measure	Fam-FFC n=3 hospital units The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan. Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.	Attention Control (Fam- FFC Ed-only) Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
Health Care Cost	320 cost in dollars Standard Deviation 160	—

Adverse Events

Fam-FFC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 32 deaths

Attention Control (Fam- FFC Ed-only)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 60 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie Boltz PhD

Penn State University

Phone: 215-962-9712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place