Hospice Problem Solving Intervention

Study Overview
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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.

Official Title
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A Problem Solving Intervention for Hospice Caregivers

Conditions
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Hospice Informal Caregivers

Intervention / Treatment
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* Behavioral: Problem Solving Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Attention Control<br>This group receives standard care with the attention of social support/ friendly interactions and serves as an attention control group. | |
| Experimental: Intervention Group 1 (Face to Face)<br>This group receives Problem Solving Therapy in face to face visits. | Behavioral: Problem Solving Therapy<br>* 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.<br>|
| Experimental: Intervention Group 2 (Video)<br>This group receives Problem Solving Therapy via video. | Behavioral: Problem Solving Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |