NCT03853291: PICT

Developing a Pain Identification and Communication Toolkit

Terminated NA Results posted Last updated 7 June 2022

What this trial tests

NA trial testing PICT Workbook in Dementia in 85 participants. Terminated before completion.

Timeline

8 March 2019

Primary endpoint
11 August 2021

11 August 2021

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	85
Start date	8 March 2019
Primary completion	11 August 2021
Estimated completion	11 August 2021
Sites	1 location across United States

Drugs / interventions tested

• PICT Workbook
• Information Pamphlet

Conditions studied

• Dementia — all drugs for Dementia →
• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 21 to 100, any sex, with Dementia or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions Primary · Post-intervention, 3 months

Group	Value	95% CI
PICT Workbook	16

Feasibility, as Measured by the Number of Participants Recruited Primary · Baseline

Group	Value	95% CI
PICT Workbook	18
Information Pamphlet	16

Acceptability, as Measured by the Number of Participants Who Report That the Intervention Was "Very Effective" or "Moderately Effective" in Helping Them Feel More Confident in Their Ability to Communicate Pain to Healthcare Providers Primary · Post-intervention, 3 months

Group	Value	95% CI
PICT Workbook	13

Caregiver Initiated Pain-related Communication, as Measured by the Number of Caregivers Who Report Making Contact With Any of the Care Recipients' Health Care Providers to Discuss Pain-related Concerns Secondary · Baseline, Post-intervention-3 months

Baseline

Group	Value	95% CI
PICT Workbook	13
Informational Pamphlet	8

3 Month Assessment

Group	Value	95% CI
PICT Workbook	12
Informational Pamphlet	8

Sponsor's own description

The proposed research will develop, refine, and pilot test the Pain Identification and Communication Toolkit (PICT), an intervention to help family caregivers of community-dwelling persons with dementia identify pain symptoms and communicate those symptoms to health care providers. Informed by self-efficacy theory, PICT will include: a) training in administering an observational assessment tool to identify pain in persons with dementia, b) coaching in effective communication about the person with dementia's pain symptoms, c) future planning for steps to take when pain is detected, and d) updating caregivers' skills through routine practice with the pain assessment tool. All components will be vetted and iteratively field-tested with a sample of racially and ethnically diverse caregivers of community-dwelling persons with dementia and health care providers. A two-group pilot randomized trial will examine the acceptability, feasibility, and preliminary impact of PICT on caregivers' initiation of pain-related communication with health care providers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia.
   Riffin C, Brody L, Mukhi P, Herr K, et al · · 2023 · cited 9× · PMID 38094933 · DOI 10.1093/geroni/igad074