Hospice Problem Solving Intervention

NCT01444027 | Completed Results

• 2 other identifiers: 369091R01NR012213-01A1
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, the demand for home hospice care has grown rapidly. Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves. It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking. In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence. The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness. This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2). The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.

Conditions

Hospice Informal Caregivers

Outcome Measures

Primary Outcomes (5)

• Caregiver Anxiety: Change From Baseline to Post-Intervention Exit

  Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.

  At Baseline and Exit (approximately 4 weeks after recruitment)

• Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit

  An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.

  At Baseline and Exit (approximately 4 weeks after recruitment)

• Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit

  An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.

  At Baseline and Exit (approximately 4 weeks after recruitment)

• Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit

  An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.

  At Baseline and Exit (approximately 4 weeks after recruitment)

• Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit

  An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.

  At Baseline and Exit (approximately 4 weeks after recruitment)

Study Arms (3)

Attention Control

NO INTERVENTION

This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.

Intervention Group 1 (Face to Face)

EXPERIMENTAL

This group receives Problem Solving Therapy in face to face visits.

Behavioral: Problem Solving Therapy

Intervention Group 2 (Video)

EXPERIMENTAL

This group receives Problem Solving Therapy via video.

Behavioral: Problem Solving Therapy

Interventions

Problem Solving Therapy BEHAVIORAL

Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.

Intervention Group 1 (Face to Face); Intervention Group 2 (Video)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled as a family/informal caregiver of a hospice patient
• years or older
• with access to a standard phone line or Internet and computer access at home
• without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
• no or only mild cognitive impairment
• speak and read English, with at least a 6th-grade education

You may not qualify if:

• lack of phone or Internet access

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (10)

• Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.

  PMID: 34793244 DERIVED

• Demiris G, Oliver DP, Washington K, Pike K. A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial. J Am Geriatr Soc. 2019 Jul;67(7):1345-1352. doi: 10.1111/jgs.15894. Epub 2019 Apr 4.

  PMID: 30946495 DERIVED

• Benson JJ, Parker Oliver D, Demiris G, Washington K. Accounts of Family Conflict in Home Hospice Care: The Central Role of Autonomy for Informal Caregiver Resilience. J Fam Nurs. 2019 May;25(2):190-218. doi: 10.1177/1074840719828091. Epub 2019 Feb 17.

  PMID: 30773970 DERIVED

• Tarter R, Demiris G, Pike K, Washington K, Parker Oliver D. Pain in Hospice Patients With Dementia: The Informal Caregiver Experience. Am J Alzheimers Dis Other Demen. 2016 Sep;31(6):524-9. doi: 10.1177/1533317516653825. Epub 2016 Jun 14.

  PMID: 27303062 DERIVED

• Oliver DP, Demiris G, Washington KT, Clark C, Thomas-Jones D. Challenges and Strategies for Hospice Caregivers: A Qualitative Analysis. Gerontologist. 2017 Aug 1;57(4):648-656. doi: 10.1093/geront/gnw054.

  PMID: 27048707 DERIVED

• Washington KT, Pike KC, Demiris G, Parker Oliver D, Albright DL, Lewis AM. Gender Differences in Caregiving at End of Life: Implications for Hospice Teams. J Palliat Med. 2015 Dec;18(12):1048-53. doi: 10.1089/jpm.2015.0214. Epub 2015 Oct 20.

  PMID: 26484426 DERIVED

• Washington KT, Pike KC, Demiris G, Oliver DP. Unique characteristics of informal hospice cancer caregiving. Support Care Cancer. 2015 Jul;23(7):2121-8. doi: 10.1007/s00520-014-2570-z. Epub 2014 Dec 30.

  PMID: 25547480 DERIVED

• Washington KT, Wittenberg-Lyles E, Oliver DP, Baldwin PK, Tappana J, Wright JH, Demiris G. Rethinking family caregiving: tailoring cognitive-behavioral therapies to the hospice experience. Health Soc Work. 2014 Nov;39(4):244-50. doi: 10.1093/hsw/hlu031.

  PMID: 25369725 DERIVED

• 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.

  PMID: 24524662 DERIVED

• 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.

  PMID: 23558847 DERIVED

Results Point of Contact

• Title: Dr. George Demiris
• Organization: University of Washington, School of Nursing

gdemiris@uw.edu

206-221-3866

Study Officials

• George Demiris, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Biobehavioral Nursing and Health Systems

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 13, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-11

Locations

US (1)