The ACTIVE Intervention to Improve Hospice Care

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: ACTIVE

• Registration Number: NCT01211340
• Lead Sponsor: Washington University School of Medicine

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2014-04
• Study Completion: 2015-07
• Results First Submitted: 2015-09-02
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-04
• Results First Posted: 2017-06-20
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 446

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACTIVE	ACTIVE	Behavioral intervention using web conferencing

Primary Outcome Measures

Name	Time	Method
Caregiver Perceptions of Pain Medicine Questionaire	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

Name	Time	Method
Anxiety	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.
Caregiver Quality of Life-Revised Subscale Emotional	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.

Trial Locations

Locations (2)

Hospice Compassus; 🇺🇸 Columbia, Missouri, United States

Hands of Hope Hospice; 🇺🇸 Saint Joseph, Missouri, United States