Clinical trial NCT01211340: The ACTIVE Intervention to Improve Hospice Care
Official title: The ACTIVE Intervention to Improve Hospice Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Hospice
Caregivers
Interdisciplinary Team
Pain management
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 446
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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)

   -

Primary outcomes:
measure: Caregiver Perceptions of Pain Medicine Questionaire
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
Secondary outcomes:
measure: Caregiver Quality of Life-Revised Subscale Emotional
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
measure: Anxiety
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
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Hospice Compassus
state: Missouri
city: Saint Joseph
country: United States
facility: Hands of Hope Hospice
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Debra Parker Oliver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.