Clinical trial NCT05980299: Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)
Official title: Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Depression
Behavior
Keywords: dementia
depressive symptoms
psychosocial intervention
feasibility
emotion
Lead sponsor: Miami University
Sponsor class: OTHER
Collaborators: name: United Church Homes
name: Penn State University
name: Virginia Polytechnic Institute and State University
name: National Institute on Aging (NIA)
First posted: 2023-08-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.

Detailed description: Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people living with dementia (PLWD) are challenging to respond to in nursing home (NH) care. Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and resistance or refusal of care.1 In addition, 30% of NH residents experience depressive symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these conditions will be referred to as distress throughout this proposal. Without appropriate guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent or positively remediate distress experienced by PLWD. The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based program designed to support care partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities. IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses using non-pharmacological approaches that align care with residents' preferences recorded in Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI program delivered by care partners experienced more pleasure, alertness, engagement, and positive verbal behavior compared with the usual care group.

Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old nonprofit national senior living provider to conduct a full implementation feasibility pilot of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D) of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) and/or a score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor appetite, restlessness).

Care partners of identified residents will be invited to be trained to deliver IPPI. The investigators anticipate that each NH will initiate engagement with 4-5 residents per month for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis (i.e., initiating intervention activities for a given resident when he/she is due for a routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions per week for 6 months. The project seeks to achieve the following specific aims:

Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents. Quantitative implementation endpoints indicating success include (a) that staff in each community will be able to identify and engage 12-15 residents experiencing both dementia (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks, measured by a count of participants; (b) that all the implementation team members (champions and care partners) can complete the online training within the first two months of initiating implementation, as indicated by the learning management system; (c) that the implementation team will be able to (i) review existing data from Section F of the MDS for all selected residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI protocols; (iii) identify a targeted expression of distress as measured by documentation in the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions per week, per targeted resident with fidelity over the course of 6 months as measured in the electronic medial record (EMR). Qualitative data to evaluate implementation will be ascertained from semi-structured interviews with implementation team members in each community to assess acceptability, feasibility, and appropriateness as well as facilitators and barriers to fidelity of the IPPI sessions.

Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness). The primary outcome measure will consist of a single variable indicating improvement, no change, or worsening of a staff-targeted behavior of distress of each resident receiving the intervention, tracked pre- and post-IPPI intervention using routinely collected data in the EMR. Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills.

IMPACT: The IPPI program teaches care partners strategies to better identify and manage their own feelings and those of PLWD through our emotion-focused communication course. In addition, the program provides highly structured and feasible protocols to guide short but impactful interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of depression). Findings from this pilot study will guide the implementation, approach, and power needed for a full-scale Stage IV effectiveness ePCT study.

Eligibility criteria: Inclusion Criteria:

Eligibility for Individualized Positive Psychosocial Interaction (IPPI)

1. Be a long-term resident in a nursing home
2. Have a score of 0-12 on the Brief Inventory for Mental Status (BIMS)
3. Either (could be both) on their most recent Minimum Data Set (MDS) 3.0 assessment A score of 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) A score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor appetite, restlessness)

Exclusion Criteria: Nursing home residents who are expected to live in the community for less than 6 months.

-

Primary outcomes:
measure: Behavioral or Psychological Symptoms of Dementia or Depressive Symptoms
timeFrame: 6 Months
Secondary outcomes:
measure: Staff-Reported
timeFrame: 1 month
Other outcomes:
Locations:
city: Beavercreek
country: United States
facility: The Trinity Community at Beavercreek
state: Ohio
city: Canal Fulton
country: United States
facility: The Chapel Hill Community
state: Ohio
city: Fairborn
country: United States
facility: The Trinity Community at Fairborn
state: Ohio
city: Jackson
country: United States
facility: The Four Winds Community
state: Ohio
city: Marietta
country: United States
facility: The Harmar Place Community
state: Ohio
city: Milford
country: United States
facility: SEM Haven
state: Ohio
city: Sandusky
country: United States
facility: The Parkvue Community
state: Ohio
Study officials:
affiliation: Miami University
name: Katherine Abbott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Haitsma KS, Curyto K, Abbott KM, Towsley GL, Spector A, Kleban M. A randomized controlled trial for an individualized positive psychosocial intervention for the affective and behavioral symptoms of dementia in nursing home residents. J Gerontol B Psychol Sci Soc Sci. 2015 Jan;70(1):35-45. doi: 10.1093/geronb/gbt102. Epub 2013 Dec 4.