The ACTIVE Intervention to Improve Hospice Care
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01211340 |
|
Recruitment Status :
Completed
First Posted : September 29, 2010
Results First Posted : June 20, 2017
Last Update Posted : February 4, 2021
|
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Debra Parker Oliver, Washington University School of Medicine
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain | Behavioral: ACTIVE | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 446 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | The ACTIVE Intervention to Improve Hospice Care |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | July 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Usual Care
Usual hospice care- there is no intervention in this arm
|
|
|
Experimental: ACTIVE
Behavioral intervention using web conferencing
|
Behavioral: 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 |
Primary Outcome Measures :
- Caregiver Perceptions of Pain Medicine Questionaire [ 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 ]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 Outcome Measures :
- Caregiver Quality of Life-Revised Subscale Emotional [ 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 ]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 [ 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 ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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:
- A standard land line telephone
- A high-speed Internet connection with operational computer
-
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)
-
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211340
Locations
| United States, Missouri | |
| Hospice Compassus | |
| Columbia, Missouri, United States, 65203 | |
| Hands of Hope Hospice | |
| Saint Joseph, Missouri, United States, 65203 | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Debra Parker Oliver, PhD | University of Missouri-Columbia |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Debra Parker Oliver, Principle Investigator, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01211340 |
| Other Study ID Numbers: |
1160518 |
| First Posted: | September 29, 2010 Key Record Dates |
| Results First Posted: | June 20, 2017 |
| Last Update Posted: | February 4, 2021 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Debra Parker Oliver, Washington University School of Medicine:
|
Hospice Caregivers Interdisciplinary Team Pain management |