Trial Outcomes & Findings for Educational Video to Improve Nursing Home Care in End-stage Dementia (NCT NCT01774799)

Results Overview

The proportion of residents with this outcome will be considered cumulatively at 6 months, including those who died; i.e., a composite of the percent of residents alive at six months who had a decision not to hospitalize and those who died before six months with this outcome prior to death. This cumulative outcome will only be based on time points following baseline as the baseline chart review data is conducted before the baseline proxy interview (i.e., before the proxy has seen the video in the intervention arm or heard options verbally in the control arm). (Decisions to forehospitalizations will be examined in a similar fashion at 3, 9, and 12 months, however the six month time frame is the primary trial outcome)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

804 participants

Primary outcome timeframe

by six months

Results posted on

2019-10-23

Participant Flow

Participants are analyzed as dyads; proxies and patients.There are 402 dyads, for a total of 804 participants.

Participant milestones

Participant milestones
Measure	Advance Care Planning Intervention Residents At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care (Control) Residents Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group	Advance Care Planning Intervention Proxies At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form.	Usual Care (Control) Proxies Proxies in control nursing homes experienced he usual advance care planning that occurs in their nursing home. Control group
Overall Study STARTED	212	190	212	190
Overall Study COMPLETED	211	189	212	190
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Advance Care Planning Intervention Residents At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care (Control) Residents Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group	Advance Care Planning Intervention Proxies At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form.	Usual Care (Control) Proxies Proxies in control nursing homes experienced he usual advance care planning that occurs in their nursing home. Control group
Overall Study Lost to Follow-up	1	1	0	0

Baseline Characteristics

Educational Video to Improve Nursing Home Care in End-stage Dementia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Advance Care Planning Intervention Residents n=212 Participants Residents with advanced dementia in intervention group	Usual Care (Control Group) Residents n=190 Participants Residents with advanced dementia in control group	Advance Care Planning Intervention Proxies n=212 Participants Proxies of residents with advanced dementia in intervention group	Usual Care (Control Group) Proxies n=190 Participants Proxies of residents with advanced dementia in control group	Total n=804 Participants Total of all reporting groups
Age, Continuous	86.0 years STANDARD_DEVIATION 7.4 • n=5 Participants	87.4 years STANDARD_DEVIATION 7.3 • n=7 Participants	61.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	62.8 years STANDARD_DEVIATION 10.6 • n=4 Participants	74.5 years STANDARD_DEVIATION 9.1 • n=21 Participants
Sex: Female, Male Female	167 Participants n=5 Participants	156 Participants n=7 Participants	146 Participants n=5 Participants	120 Participants n=4 Participants	589 Participants n=21 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants	70 Participants n=4 Participants	215 Participants n=21 Participants
Race/Ethnicity, Customized white	178 Participants n=5 Participants	172 Participants n=7 Participants	177 Participants n=5 Participants	173 Participants n=4 Participants	700 Participants n=21 Participants
Race/Ethnicity, Customized non-white	34 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants	17 Participants n=4 Participants	104 Participants n=21 Participants
Region of Enrollment United States	212 participants n=5 Participants	190 participants n=7 Participants	212 participants n=5 Participants	190 participants n=4 Participants	804 participants n=21 Participants

PRIMARY outcome

Timeframe: by six months

The proportion of residents with this outcome will be considered cumulatively at 6 months, including those who died; i.e., a composite of the percent of residents alive at six months who had a decision not to hospitalize and those who died before six months with this outcome prior to death. This cumulative outcome will only be based on time points following baseline as the baseline chart review data is conducted before the baseline proxy interview (i.e., before the proxy has seen the video in the intervention arm or heard options verbally in the control arm). (Decisions to forehospitalizations will be examined in a similar fashion at 3, 9, and 12 months, however the six month time frame is the primary trial outcome)

Outcome measures

Outcome measures
Measure	Advance Care Planning Intervention n=211 Participants At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care n=189 Participants Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group
Documented Decisions to Forgo Hospitalization	133 Participants	119 Participants

SECONDARY outcome

Timeframe: by 12 months

This is a sub primary outcome. The modified ITT population will be the subgroup of residents who begin the study without a documented decision to forego hospitalization, and the outcome will be acquisition of a documented decision to forego hospitalization over the 12 month follow-up period. The analysis will utilize Cox proportional hazards regression. Results will be summarized using a hazard ratio and associated 95% confidence interval as well as plots of the cumulative incidence by group.

Outcome measures

Outcome measures
Measure	Advance Care Planning Intervention n=108 Participants At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care n=92 Participants Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group
Acquisition of Decisions Not to Hospitalize	41 Participants	30 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Missing data are due to missing proxy interviews at certain follow-up time points

The proportion of proxies who have chosen comfort care (versus intermediate or intensive care) based on telephone interviews will be considered cumulatively at each assessment. At 6 months the outcome will include the proportion of proxies choosing comfort care up to and including the 6 month interview. Cumulative proportions will include data from the baseline interview for the control group, and baseline immediate post video interview for intervention group.The proportion of proxies choosing comfort care will be compared between the intervention and control groups using an extension of logistic regression based on general estimating equations (GEE) to account for clustering at the NH level at each time period.

Outcome measures

Outcome measures
Measure	Advance Care Planning Intervention n=209 Participants At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care n=182 Participants Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group
Acquisition of Preference for Level of Care	151 Participants	133 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: by 6 months

The proportion of residents who acquired a documented advance directive to forego tube-feeding will be compared in the intervention versus control group.

Outcome measures

Outcome measures
Measure	Advance Care Planning Intervention n=211 Participants At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care n=189 Participants Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group
Acquisition of Other Documented Advance Care Planning	148 Participants	117 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: by 12 months

Burdensome treatments include: Hospitals transfers (hospitalizations or emergency room visits), tube feeding or parenteral therapy. The rate of burdensome treatments per 1000 resident days was compared between the intervention and control arms.

Outcome measures

Outcome measures
Measure	Advance Care Planning Intervention n=211 Participants At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Advance care planning intervention	Usual Care n=189 Participants Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Control group
Burdensome Treatments	33 Participants	25 Participants

Adverse Events

Advance Care Planning Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 86 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 89 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Susan Mitchell

Hebrew SeniorLife

Phone: 617-971-5326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place