Developing a Pain Identification and Communication Toolkit (PICT)
6 juin 2022 mis à jour par: Weill Medical College of Cornell University
Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
85
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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New York, New York, États-Unis, 10065
- Weill Cornell Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans à 100 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
For all phases:
Inclusion Criteria:
- Family caregiver
- Age 21 or older
- English speaking
- Cognitively intact
- Provides at least 8 hours of care per week to a person with dementia and pain
- Has provided care for at least 6 months
Exclusion Criteria:
- Paid caregiver
- Age 20 or younger
- Non-English speaking
- Cognitively impaired
- Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis
- Has not provided care for at least 6 months
- Currently enrolled in hospice
- The patient to whom the caregiver provides assistance is in enrolled in hospice
- Care recipient does not have dementia diagnosis or pain diagnosis
For field test and interview phases:
Healthcare professionals:
- Currently providing clinical services to persons with dementia and/or chronic pain
- Has provided these clinical services for at least 1 year
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: PICT Workbook
PICT Workbook components includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set through routine practice.
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PICT Workbook: The PICT workbook is a 31-page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set.
Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.
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Comparateur actif: Information Pamphlet
Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
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Pamphlet with information about pain and dementia and links to Alzheimer's Association
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Aucune intervention: Family Caregivers - Interview Phase
Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone.
The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
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Aucune intervention: Healthcare Providers - Interview Phase
Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone.
The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
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Aucune intervention: Family Caregivers - Field Test Phase
Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
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Aucune intervention: Healthcare Providers - Field Test Phase
Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Délai: Post-intervention, 3 months
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Post-intervention, 3 months
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Feasibility, as Measured by the Number of Participants Recruited
Délai: Baseline
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Baseline
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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
Délai: Post-intervention, 3 months
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Post-intervention, 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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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
Délai: Baseline, Post-intervention-3 months
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Baseline, Post-intervention-3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Cary Reid, MD/PhD, Weill Medical College of Cornell University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 mars 2019
Achèvement primaire (Réel)
11 août 2021
Achèvement de l'étude (Réel)
11 août 2021
Dates d'inscription aux études
Première soumission
22 février 2019
Première soumission répondant aux critères de contrôle qualité
22 février 2019
Première publication (Réel)
25 février 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juin 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2022
Dernière vérification
1 juin 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1811019718
- 3P30AG022845-15S1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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