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The ACTIVE Intervention to Improve Hospice Care

This study is currently recruiting participants.
Verified September 2011 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01211340
First received: September 23, 2010
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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 (RQ1). We will investigate whether the assessment of the ICG perception of pain management will identify those who will benefit most (RQ2) and whether changes in the perceptions of informal caregivers will result in improvement of patient pain (RQ3). With a cost effective intervention (RQ4, 5) and an understanding for a translation plan (RQ6, 7), involving the informal caregivers and patients (when able) on the IDT team can become the standard of care. This intervention may have the potential to influence not only hospice care but also care for other patients experiencing chronic or terminal pain.


Condition Intervention
Caregiver
 Other: ACTIVE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The ACTIVE Intervention to Improve Hospice Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

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 ] [ Designated as safety issue: Yes ]
    This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications


Secondary Outcome Measures:
  • Caregiver Quality of Life-Revised [ Time Frame: Every 14 days until the death of the patient for an average of 45 days ] [ Designated as safety issue: No ]
    This four question measure asks caregivers to rate their quality of life

  • Anxiety [ Time Frame: Every 14 days until the death of the patient for an average of 45 days ] [ Designated as safety issue: No ]
    This measure determines the level of anxiety experienced by a hospice caregiver

  • Lubbens Social Network Scale-6 [ Time Frame: Every 30 days until the death of the patient for an average of 45 days ] [ Designated as safety issue: No ]
    This instrument measures the interaction with social networks for the hospice caregiver


Estimated Enrollment: 554
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
This arm serves as the control, individuals will not receive the intervention but will receive all measures
 Other: 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
Experimental: Intervention Arm
These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
 Other: 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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211340

Contacts
Contact: Debra Parker Oliver, PhD 573-884-5301 oliverdr@missouri.edu
Contact: Tami Day, BSN daytm@missouri.edu

Locations
United States, Missouri
Hospice Compassus Recruiting
Columbia, Missouri, United States, 65203
Contact: Tami Day, BSN         Daytm@missouri.edu    
Hands of Hope Hospice Recruiting
St Joseph, Missouri, United States, 65203
Contact: Megan Mooney, BSW         mooneym@missouri.edu    
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Debra Parker Oliver, PhD University of Missouri-Columbia
  More Information

No publications provided by University of Missouri-Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Debra Parker Oliver, PhD, MSW, Principle Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01211340     History of Changes
Other Study ID Numbers: 1160518
Study First Received: September 23, 2010
Last Updated: September 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Hospice
Caregivers
Interdisciplinary Team
Pain management

ClinicalTrials.gov processed this record on May 22, 2013