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Hospice Problem Solving Intervention

NCT ID: NCT01444027

Last Updated: 2017-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hospice Informal Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Attention Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group 1 (Face to Face)

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

Group Type EXPERIMENTAL

Problem Solving Therapy

Intervention Type 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 2 (Video)

This group receives Problem Solving Therapy via video.

Group Type EXPERIMENTAL

Problem Solving Therapy

Intervention Type 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.

Interventions

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Problem Solving Therapy

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* enrolled as a family/informal caregiver of a hospice patient
* 18 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

Exclusion Criteria

* lack of phone or Internet access
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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George Demiris

Professor, Biobehavioral Nursing and Health Systems

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Demiris, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34793244 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30946495 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30773970 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27303062 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27048707 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26484426 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25547480 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25369725 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24524662 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23558847 (View on PubMed)

Other Identifiers

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1R01NR012213-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

36909

Identifier Type: -

Identifier Source: org_study_id