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.

Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)

Dementia

Depression

Behavior

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.

Individualized Positive Psychosocial Interaction

The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (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 investigators will look to see if that item has decreased (moved to zero) on the 6 month MDS follow-up. Lower scores (zero) indicate no distress while higher scores (1 or greater) indicate distress.

Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills as measured via a pre and post test administered just before and immediately after completing the training.

The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.

Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status