The ACTIVE Intervention to Improve Hospice Care

January 15, 2021 updated by: Debra Parker Oliver, Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Hospice Compassus
      • Saint Joseph, Missouri, United States, 65203
        • Hands of Hope Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Debra Parker Oliver, PhD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1160518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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