A Problem Solving Intervention for Hospice Caregivers

NCT03712410 | Completed Results

• 2 other identifiers: 828990R01NR012213
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 1

Brief Summary

Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.

Conditions

Anxiety Generalized; Quality of Life; Depression

Outcome Measures

Primary Outcomes (3)

• Table 2. Comparison of 4 Groups

  Comparison of 4 groups Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress) Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life)

  from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)

• Table 3. Comparison of Traditional PISCES vs. Online PISCES

  Comparison of Traditional PISCES vs. Online PISCES Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

  from baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30)

• Table 4. Within-Group Comparison Baseline vs. Follow-up

  Within-Group Comparison Baseline vs. Follow-up Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome

  from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)

Study Arms (4)

Group 1 (PISCES face to face)

ACTIVE COMPARATOR

Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely "Attitude" and "Defining the Problem and Setting Realistic Goals." During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works.

Behavioral: PISCES

Group 2 (PISCES delivered in a hybrid format)

EXPERIMENTAL

In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone.

Behavioral: PISCES

Group 3 (PISCESplus)

EXPERIMENTAL

PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video.

Behavioral: PISCES

Group 4 (PISCESplus online)

EXPERIMENTAL

Participants in this group receive the PISCES plus intervention (the PISCES intervention with the enhancement of the positive reappraisal elements) delivered fully online. All assessments and sessions take place online.

Behavioral: PISCES

Interventions

PISCES BEHAVIORAL

The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.

Group 1 (PISCES face to face); Group 2 (PISCES delivered in a hybrid format); Group 3 (PISCESplus); Group 4 (PISCESplus online)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The investigator's inclusion criteria cover all genders (and gender is based on self-representation of gender identity).
• Healthy Volunteers: Yes
• 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)
• speak and read English, with at least a 6th-grade education

You may not qualify if:

• hearing or visual impairment that prohibits from conducting phone conversations or video conference sessions

Sponsors & Collaborators

• George Demiris, PhD: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depression

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Because of the COVID pandemic we implemented some changes in the study protocol for each group and converted data collection to online questionnaires.

Results Point of Contact

• Title: George Demiris
• Organization: University of Pennsylvania

gdemiris@upenn.edu

2158988559

Study Officials

• George Demiris, PhD

  University of Pennsylvania

  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: SPONSOR INVESTIGATOR
• PI Title: PIK Professor

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: October 23, 2018
• Primary Completion: December 15, 2022
• Study Completion: December 30, 2022
• Last Updated: February 16, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)