Trial Outcomes & Findings for The ACTIVE Intervention to Improve Hospice Care (NCT NCT01211340)

Last Updated: 2021-02-04

Results Overview

This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications. Scores on items vary from 1-5 with the lower scores indicating more problematic perceptions of pain management. A Total score is computed between 16-80 Only the last available measure will be used to reflect the measure closest to time of death.

Recruitment status

COMPLETED

Study phase

Target enrollment

446 participants

Primary outcome timeframe

Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

Results posted on

2021-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care This arm serves as the control, individuals will not receive the intervention but will receive all measures	Intervention Arm These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient
Overall Study STARTED	223	223
Overall Study COMPLETED	223	223
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The ACTIVE Intervention to Improve Hospice Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=223 Participants This arm serves as the control, individuals will not receive the intervention but will receive all measures	Intervention Arm n=223 Participants These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient	Total n=446 Participants Total of all reporting groups
Age, Continuous	59.2 years STANDARD_DEVIATION 13.3 • n=5 Participants	60.1 years STANDARD_DEVIATION 12.5 • n=7 Participants	59.7 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	168 Participants n=7 Participants	350 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	55 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	221 Participants n=5 Participants	220 Participants n=7 Participants	441 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	205 Participants n=5 Participants	204 Participants n=7 Participants	409 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	223 participants n=5 Participants	223 participants n=7 Participants	446 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

Outcome measures

Outcome measures
Measure	Usual Care n=223 Participants This arm serves as the control, individuals will not receive the intervention but will receive all measures	Intervention Arm n=223 Participants These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient
Caregiver Perceptions of Pain Medicine Questionaire Baseline	49.6 units on a scale Standard Deviation 7.3	49 units on a scale Standard Deviation 7.43
Caregiver Perceptions of Pain Medicine Questionaire Last Measure	50.3 units on a scale Standard Deviation 7.12	50.5 units on a scale Standard Deviation 7.33

SECONDARY outcome

Timeframe: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

This is one domain of a four domain instrument. It involves one question with a range of 0-10.Only the last available measure will be used to reflect the measure closest to time of death.

Outcome measures

Outcome measures
Measure	Usual Care n=223 Participants This arm serves as the control, individuals will not receive the intervention but will receive all measures	Intervention Arm n=223 Participants These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient
Caregiver Quality of Life-Revised Subscale Emotional Baseline	7.06 units on a scale Standard Deviation 2.26	7.61 units on a scale Standard Deviation 1.93
Caregiver Quality of Life-Revised Subscale Emotional Last Measure	6.95 units on a scale Standard Deviation 2.08	7.19 units on a scale Standard Deviation 2.03

SECONDARY outcome

Timeframe: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

This measure determines the level of anxiety experienced by a hospice caregiver. Total scores range from 0-21 with higher scores representing more anxiety. Only the last available measure will be used to reflect the measure closest to time of death.

Outcome measures

Outcome measures
Measure	Usual Care n=223 Participants This arm serves as the control, individuals will not receive the intervention but will receive all measures	Intervention Arm n=223 Participants These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient
Anxiety Baseline	6.65 units on a scale Standard Deviation 5.33	5.86 units on a scale Standard Deviation 5.16
Anxiety Last Measure	6.37 units on a scale Standard Deviation 5.81	5.86 units on a scale Standard Deviation 5.16

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Debra Parker Oliver

University of Missouri

Phone: 573-884-5301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place