The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Change in caregiver's ability to recognize pain
研究概览
简要总结
This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias (ADRD). PICT provides training in observational pain assessment and coaching in effective pain communication techniques. It will recruit participants from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients.
详细描述
Up to 60% of older persons with Alzheimer's disease and related dementias (ADRD) suffer from bothersome pain and nearly half experience pain-related activity limitations. Despite best-practice guidelines calling for routine pain assessment of persons with ADRD, pain is severely under-detected and poorly managed in this population. A major barrier to the identification and treatment of pain in persons with ADRD is impaired communication. Informal (family) caregivers are well situated to detect pain and facilitate management in persons with ADRD, given their extensive involvement in care activities. However, caregivers receive virtually no guidance or training in these areas. The Pain Identification and Communication Toolkit (PICT) is a multicomponent intervention for ADRD caregivers that provides training in observational pain assessment and coaching in effective pain communication techniques. PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist. This project aims to (1) determine the efficacy of PICT compared with an Attention Control (AC) condition, (2) identify the patient and caregiver factors that may moderate the effects of PICT on study outcomes, and (3) evaluate the mechanisms (theoretically-derived variables) by which PICT affects study outcomes. Participants will be recruited from programs of all-inclusive care for the elderly (PACE) programs and partnering health care clinics. They will complete assessments at 0 (baseline), 1, 3, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind allocation. The outcomes assessors will be masked to group allocation. Other research personnel (investigator, project manager, interventionist) may become aware of group allocation. Participants will be asked not to disclose to outcomes assessors the group to which they are assigned.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CAREGIVER PARTICIPANTS
- •Inclusion Criteria:
- •Age 21 or older
- •English speaking
- •Cognitively intact (BOMC ≤10)
- •Provides care to a community-dwelling adult with dementia or cognitive impairment who also has a pain diagnosis
- •Care recipient is not enrolled in hospice
- •Visits the care recipient at least weekly
- •Accessible by telephone
排除标准
- •Paid caregiver
- •Age 20 or younger
- •Non-English speaking
- •Cognitively impaired
- •Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis
- •Currently enrolled in hospice
- •The patient to whom the caregiver provides assistance is enrolled in hospice
- •Visits care recipient less than weekly
- •Not accessible by telephone.
- •PATIENT PARTICIPANTS
- •Inclusion Criteria:
- •Residing in community settings
- •Record of dementia or cognitive impairment
- •Diagnosis of pain
- •Responsive to environment
- •No terminal illness with life expectancy <6 months
- •Not in active cancer treatment
- •Exclusion Criteria:
- •Lives in a residential facility (such as a nursing home or assisted living)
- •Enrolled in hospice
- •No dementia or cognitive impairment
- •Unresponsive to environment
- •Has terminal illness with life expectancy <6 months
- •Are in active cancer treatment
研究组 & 干预措施
Pain Identification and Communication Toolkit
The Pain Identification and Communication Toolkit (PICT) components include: a) training using an observational assessment tool to detect pain in persons with Alzheimer's disease and related dementias (ADRD), b) coaching and feedback by a trained interventionist in effective strategies for communicating with providers about 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 and homework exercises. A trained interventionist will deliver the PICT intervention following a manualized protocol to the caregiver participants. Patient participants will not receive any intervention.
干预措施: Pain Identification and Communication Toolkit (Behavioral)
Attention Control
The Attention Control (AC) condition, also known as the Health Promotion Program (HPP), focuses on caregiver health promotion topics, such as nutrition, exercise, and sleep. A trained interventionist will provide education on these topics using scripted material, use active listening and open questioning techniques, and provide the HPP participants with worksheets (e.g., meal plans) to complete between sessions to mirror the homework activities in the PICT condition for the caregiver participants. Patient participants will not receive any intervention.
干预措施: Health Promotion Program (Behavioral)
结局指标
主要结局
Change in caregiver's ability to recognize pain
时间窗: Baseline, 1 month, 3 month, 6 month
Change in caregiver's ability to recognize pain as measured by the absolute difference between the caregiver-reported PAINAD score and correct PAINAD score (i.e. absolute value of the deviance between the scores). The PAINAD is scored on a scale from 0-10 where 0 means "no pain" and 10 means "severe pain." Participants will be shown multiple videos on which to score the PAINAD.
Change in caregiver-reported pain communication
时间窗: Baseline, 1 month, 3 month, 6 month
Change in caregiver-reported pain-related communication as measured by ten questions from the Perceived Involvement in Care Scale (PICS). The range of possible scores is 10-50, where higher scores indicate greater caregiver involvement in patient consultation.
Change in pain management discussions with health care providers
时间窗: Baseline, 1 month, 3 month, 6 month
Change in pain management discussions as measured by the combined number of phone calls and appointments made to discuss pain management recorded in the patient's medical chart.
Change in concordance between patient and caregiver pain ratings
时间窗: Baseline, 1 month, 3 month, 6 month
Change in concordance in patient and caregiver pain ratings as measured by the absolute difference between caregiver and patient pain ratings of the patient's pain on the Iowa Pain Thermometer (IPT). The IPT is scored on a scale of 0-10 where 0 means "no pain" and 10 means "the most intense pain imaginable."
Change in caregiver's ability to recognize pain behaviors
时间窗: Baseline, 1 month, 3 month, 6 month
Change in caregiver's ability to recognize pain behaviors as measured by the absolute difference between the number of caregiver-reported behaviors within each of the 5 PAINAD behaviors (i.e., Breathing, Negative Vocalization, Facial Expression, Body Language, Consolability) and correct number of behaviors. Participants will be shown multiple videos on which to score the PAINAD.
次要结局
- Change in caregiver distress level(Baseline, 1 month, 3 month, 6 month)
- Change in caregiver self-efficacy in pain recognition(Baseline, 1 month, 3 month, 6 month)
- Change in caregiver self-efficacy in pain-related communication(Baseline, 1 month, 3 month, 6 month)
- Change in patient's behavioral disturbance(Baseline, 1 month, 3 month, 6 month)
- Change in caregiver self-confidence in recognizing pain(Baseline, 1 month, 3 month, 6 month)
- Change in patient's pain treatments or regimens(Baseline, 1 month, 3 month, 6 month)
- Change in caregiver burden(Baseline, 1 month, 3 month, 6 month)