The ACTIVE Intervention to Improve Hospice Care

Pain Clinical Trial

Official title:

The ACTIVE Intervention to Improve Hospice Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211340
• Other study ID #: 1160518
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: July 2015

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: July 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Hospice Compassus	Columbia	Missouri
United States	Hands of Hope Hospice	Saint Joseph	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Perceptions of Pain Medicine Questionaire	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	Caregiver Quality of Life-Revised Subscale Emotional	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
Secondary	Anxiety	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