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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual hospice care- there is no intervention in this arm | |
| ACTIVE | Experimental | Behavioral intervention using web conferencing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTIVE | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria: Informal Caregiver Inclusion Criteria
Informal caregiver of an enrolled hospice patient
Age 18 or over and legally able to provide informed consent
Involved in decisions related to pain medications
Access to at least one of the below:
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
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Debra Parker Oliver, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospice Compassus | Columbia | Missouri | 65203 | United States | ||
| Hands of Hope Hospice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23104974 | Background | Kruse RL, Parker Oliver D, Wittenberg-Lyles E, Demiris G. Conducting the ACTIVE randomized trial in hospice care: keys to success. Clin Trials. 2013 Feb;10(1):160-9. doi: 10.1177/1740774512461858. Epub 2012 Oct 25. | |
| 27465403 | Result | Parker Oliver D, Demiris G, Washington K, Kruse RL, Petroski G. Hospice Family Caregiver Involvement in Care Plan Meetings: A Mixed-Methods Randomized Controlled Trial. Am J Hosp Palliat Care. 2017 Nov;34(9):849-859. doi: 10.1177/1049909116661816. Epub 2016 Jul 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | This arm serves as the control, individuals will not receive the intervention but will receive all measures |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | This arm serves as the control, individuals will not receive the intervention but will receive all measures |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | This arm serves as the control, individuals will not receive the intervention but will receive all measures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Parker Oliver | University of Missouri | 573-884-5301 | oliverdr@missouri.health.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. | 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 |
| Saint Joseph |
| Missouri |
| 65203 |
| United States |
| 24524662 | Derived | Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13. |
| 24295096 | Derived | Parker Oliver D, Albright DL, Washington K, Wittenberg-Lyles E, Gage A, Mooney M, Demiris G. Hospice caregiver depression: the evidence surrounding the greatest pain of all. J Soc Work End Life Palliat Care. 2013;9(4):256-71. doi: 10.1080/15524256.2013.846891. |
| 24246789 | Derived | Albright DL, Kruse RL, Oliver DP, Washington K, Cagle J, Demiris G. Testing the factorial validity of scores from the caregiver pain medicine questionnaire. J Pain Symptom Manage. 2014 Jul;48(1):99-109. doi: 10.1016/j.jpainsymman.2013.08.014. Epub 2013 Nov 15. |
| 23937064 | Derived | Wittenberg-Lyles E, Goldsmith J, Oliver DP, Demiris G, Kruse RL, Van Stee S. Using medical words with family caregivers. J Palliat Med. 2013 Sep;16(9):1135-9. doi: 10.1089/jpm.2013.0041. Epub 2013 Aug 12. |
| 23558847 | Derived | Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4. |
| 23522518 | Derived | Wittenberg-Lyles E, Goldsmith J, Oliver DP, Demiris G, Kruse RL, Van Stee S. Exploring oral literacy in communication with hospice caregivers. J Pain Symptom Manage. 2013 Nov;46(5):731-6. doi: 10.1016/j.jpainsymman.2012.11.006. Epub 2013 Mar 21. |
| 23233538 | Derived | Baldwin PK, Wittenberg-Lyles E, Kruse RL, Demiris G, Parker Oliver D. Pain management and the African American hospice caregiver: a case report. Am J Hosp Palliat Care. 2013 Dec;30(8):795-8. doi: 10.1177/1049909112469274. Epub 2012 Dec 10. No abstract available. |
| 23036014 | Derived | Washington KT, Wittenberg-Lyles E, Parker Oliver D, Demiris G, Shaunfield S, Crumb E. Application of the VALUE communication principles in ACTIVE hospice team meetings. J Palliat Med. 2013 Jan;16(1):60-6. doi: 10.1089/jpm.2012.0229. Epub 2012 Oct 4. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
|
| 0 |
| 223 |
| 0 |
| 223 |
| EG001 | 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 | 0 | 223 | 0 | 223 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
|
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. |
| Regression, Linear |
| .15 |
| Superiority or Other (legacy) |
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. |
| Regression, Linear |
| .89 |
| Superiority or Other (legacy) |