Trial Outcomes & Findings for Enabling Advance Directive Completion (NCT NCT01746368)

NCT ID: NCT01746368

Last Updated: 2015-06-12

Results Overview

An advance directive was considered completed upon confirmation of the scanned document in the medical record.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Up to 1 month after intervention
• Results posted on: 2015-06-12

Participant Flow

From May 2013 - September 2013, 50 subjects were recruited from outpatient clinics, rural mobile clinic, home-based primary care, and residential treatment units.

Participant milestones

Measure	Nurse-Supported Advance Care Planning Intervention The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
Overall Study STARTED	33	17
Overall Study Recieved Allocated Intervention	31	8
Overall Study Assessment Completed	31	16
Overall Study Analyzed for AD Completion Rate	32	17
Overall Study Analyzed for Satisfaction	30	16
Overall Study COMPLETED	31	16
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Nurse-Supported Advance Care Planning Intervention The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Enabling Advance Directive Completion

Baseline characteristics by cohort

Measure	Nurse-Supported Advance Care Planning Intervention n=33 Participants The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual n=17 Participants The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	16 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	51.24 Years STANDARD_DEVIATION 11.48 • n=5 Participants	48.35 Years STANDARD_DEVIATION 14.95 • n=7 Participants	50.26 Years STANDARD_DEVIATION 12.68 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	15 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Black Non-Hispanic	21 Participants n=5 Participants	9 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Black Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized 2 or more races Non-Hispanic	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other Non-Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown/Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Rurality Rural zip code	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Rurality Non-rural zip code	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Desire for Information About Advance Directives Yes	29 Participants n=5 Participants	14 Participants n=7 Participants	43 Participants n=5 Participants
Desire for Information About Advance Directives No	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Desire for Help Completing an Advance Directive Yes	29 Participants n=5 Participants	12 Participants n=7 Participants	41 Participants n=5 Participants
Desire for Help Completing an Advance Directive No	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Desire for Help Completing an Advance Directive No answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Desire for Risks, Benefits, and Alternatives Information About Life-sustaining Procedures Yes	29 Participants n=5 Participants	10 Participants n=7 Participants	39 Participants n=5 Participants
Desire for Risks, Benefits, and Alternatives Information About Life-sustaining Procedures No	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 month after intervention

Population: intention to treat (ITT)

An advance directive was considered completed upon confirmation of the scanned document in the medical record.

Outcome measures

Measure	Nurse-Supported Advance Care Planning Intervention n=32 Participants The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual n=17 Participants The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
Number of Participants Who Completed an Advance Directive	30 participants	5 participants

SECONDARY outcome

Timeframe: For participants who received the allocated intervention, up to one month after intervention; for all others, up to 90 days after consenting to the study.

Score on the Client Satisfaction Questionnaire-8 (CSQ-8). The overall score is produced by summing all item responses. For the CSQ-8, scores range from 8 to 32, with higher values indicating higher satisfaction.

Response options differ from item to item, but all are based on a four-point scale.

All items are positively worded; however, the directionality of response options span the spectrum from very negative to very positive; and, the numerical anchors for items are reversed randomly (from high to low or low to high) from item to item to minimize stereotypic response sets. The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction.

Outcome measures

Measure	Nurse-Supported Advance Care Planning Intervention n=30 Participants The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual n=16 Participants The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
Satisfaction	31.03 Scores on a scale Standard Deviation 1.38	28.00 Scores on a scale Standard Deviation 4.13

Adverse Events

Nurse-Supported Advance Care Planning Intervention

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Care-as-Usual

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nurse-Supported Advance Care Planning Intervention n=33 participants at risk The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual n=17 participants at risk The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
Psychiatric disorders Admission to acute psychiatric unit	3.0% 1/33 • Number of events 1 • Participants were followed for the duration of their participation in the study, up to 90 days.	0.00% 0/17 • Participants were followed for the duration of their participation in the study, up to 90 days.
General disorders Admission to hospital	0.00% 0/33 • Participants were followed for the duration of their participation in the study, up to 90 days.	5.9% 1/17 • Number of events 1 • Participants were followed for the duration of their participation in the study, up to 90 days.

Other adverse events

Measure	Nurse-Supported Advance Care Planning Intervention n=33 participants at risk The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.	Care-as-Usual n=17 participants at risk The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • Number of events 1 • Participants were followed for the duration of their participation in the study, up to 90 days.	0.00% 0/17 • Participants were followed for the duration of their participation in the study, up to 90 days.

Additional Information

Ann Mahaney-Price, DNP

Tuscaloosa VA Medical Center (Retired)

Phone: 205-409-8301

Email: amparnp@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place