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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Dementia; Behavior
• Intervention / Treatment: Behavioral: Individualized Positive Psychosocial Interaction

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Abbott, PhD; Phone Number: 5135290869; Email: abbottkm@miamioh.edu

Study Locations

• United States
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • The Trinity Community at Beavercreek
    • Canal Fulton, Ohio, United States, 44614
      • The Chapel Hill Community
    • Fairborn, Ohio, United States, 45324
      • The Trinity Community at Fairborn
    • Jackson, Ohio, United States, 45640
      • The Four Winds Community
    • Marietta, Ohio, United States, 45750
      • The Harmar Place Community
    • Milford, Ohio, United States, 45150
      • SEM Haven
    • Sandusky, Ohio, United States, 44870
      • The Parkvue Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.	Behavioral: Individualized Positive Psychosocial Interaction; The intervention involves a brief positive interaction around a preferred activity or personal care routine.; Other Names: Individualized Positive Psychosocial Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral or Psychological Symptoms of Dementia or Depressive Symptoms	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.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff-Reported	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.	1 month

Collaborators and Investigators

• Sponsor: Miami University
• Collaborators: National Institute on Aging (NIA); Virginia Polytechnic Institute and State University; Penn State University; United Church Homes
• Investigators: Principal Investigator: Katherine Abbott, PhD, Miami University

Publications and helpful links

General Publications

• 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.

Helpful Links

• IPPI program

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: dementia; feasibility; psychosocial intervention; emotion; depressive symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: FY22_Pilot5_Abbott; U54AG063546 (U.S. NIH Grant/Contract); 403853 (Other Identifier: Miami University Index)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data (IPT) available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No