Pain
Conditions
Keywords
Hospice, Caregivers, Interdisciplinary Team, Pain management
Brief summary
The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.
Detailed description
The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this RCT will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices. We will rigorously test the effectiveness of the ACTIVE intervention. We will investigate whether the assessment of the informal caregivers perception of pain management will identify those who will benefit most and whether changes in the perceptions of informal caregivers will result in improvement of patient pain. We will explore barriers and challenges in the implementation of this into every day practice within hospice
Interventions
BEHAVIORALACTIVE
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
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
Informal Caregiver Inclusion Criteria 1. Informal caregiver of an enrolled hospice patient 2. Age 18 or over and legally able to provide informed consent 3. Involved in decisions related to pain medications 4. Access to at least one of the below: 1. A standard land line telephone 2. A high-speed Internet connection with operational computer 5. Without functional hearing loss or with a hearing aid that allows the participant to conduct phone or Internet conversations as assessed by the research staff (by questioning and observation \-
Exclusion criteria
Informal caregivers of hospice patients with a life expectancy less than 14 days as assessed by the hospice nurse with the palliative performance scale (PPS) (99) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Perceptions of Pain Medicine Questionaire | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Quality of Life-Revised Subscale Emotional | 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. |
| Anxiety | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care This arm serves as the control, individuals will not receive the intervention but will receive all measures | 223 |
| 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 | 223 |
| Total | 446 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention Arm |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 13.3 | 59.7 years STANDARD_DEVIATION 12.9 | 60.1 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 221 Participants | 441 Participants | 220 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 23 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 205 Participants | 409 Participants | 204 Participants |
| Region of Enrollment United States | 223 participants | 446 participants | 223 participants |
| Sex: Female, Male Female | 182 Participants | 350 Participants | 168 Participants |
| Sex: Female, Male Male | 41 Participants | 96 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 223 | 0 / 223 |
| serious Total, serious adverse events | 0 / 223 | 0 / 223 |
Outcome results
Primary
Caregiver Perceptions of Pain Medicine Questionaire
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Caregiver Perceptions of Pain Medicine Questionaire | Baseline | 49.6 units on a scale | Standard Deviation 7.3 |
| Usual Care | Caregiver Perceptions of Pain Medicine Questionaire | Last Measure | 50.3 units on a scale | Standard Deviation 7.12 |
| Intervention Arm | Caregiver Perceptions of Pain Medicine Questionaire | Baseline | 49 units on a scale | Standard Deviation 7.43 |
| Intervention Arm | Caregiver Perceptions of Pain Medicine Questionaire | Last Measure | 50.5 units on a scale | Standard Deviation 7.33 |
Comparison: The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.p-value: 0.18Regression, Linear
Comparison: To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficientp-value: 0.18Spearmans rank
Secondary
Anxiety
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Anxiety | Baseline | 6.65 units on a scale | Standard Deviation 5.33 |
| Usual Care | Anxiety | Last Measure | 6.37 units on a scale | Standard Deviation 5.81 |
| Intervention Arm | Anxiety | Baseline | 5.86 units on a scale | Standard Deviation 5.16 |
| Intervention Arm | Anxiety | Last Measure | 5.86 units on a scale | Standard Deviation 5.16 |
Comparison: The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.p-value: 0.89Wilcoxon (Mann-Whitney)
Comparison: The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.p-value: 0.89Regression, Linear
Secondary
Caregiver Quality of Life-Revised Subscale Emotional
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Caregiver Quality of Life-Revised Subscale Emotional | Baseline | 7.06 units on a scale | Standard Deviation 2.26 |
| Usual Care | Caregiver Quality of Life-Revised Subscale Emotional | Last Measure | 6.95 units on a scale | Standard Deviation 2.08 |
| Intervention Arm | Caregiver Quality of Life-Revised Subscale Emotional | Last Measure | 7.19 units on a scale | Standard Deviation 2.03 |
| Intervention Arm | Caregiver Quality of Life-Revised Subscale Emotional | Baseline | 7.61 units on a scale | Standard Deviation 1.93 |
Comparison: The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.p-value: 0.15Wilcxon Rank Sum Test
Comparison: The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.p-value: 0.15Regression, Linear