Nursing Home Pain Management Algorithm Clinical Trial

Swedish Medical Center

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Behavioral: Algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT01399567

5R01NR009100

Details and patient eligibility

About

Pain assessment and management deficiencies in nursing homes (NHs) are well documented. Unrelieved pain in this setting results in poorer resident outcomes, including depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled with intense diffusion strategies in improving pain, physical function and depression among NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.

Full description

Inadequate pain management in nursing homes (NHs) is well documented. Unrelieved pain in this setting results in depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm delivered using intense diffusion strategies. Outcomes are facility pain practices and residents' pain, physical function and depression. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.

Enrollment: 396 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• long-term nursing home residents,
• 65 years and older,
• with moderate or greater pain in the week prior to screening,
• residing in a participating facility,
• who consent to participate (or whose surrogate decisionmaker consents to participation)

Exclusion criteria

• short-term stay patients,
• persons less than 65 years,
• residents on hospice

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

396 participants in 2 patient groups

Algorithm

Experimental group

Description:

The NH pain management algorithm is a series of decision-making tools that begins with regular, comprehensive pain assessment matched to residents' cognitive status and proceed through analgesic therapy appropriate to the character, severity, and pattern of pain. The algorithm is coupled with intense diffusion strategies (e.g., education, consultation, boosters) to increase adoption of these evidence-based practices

Treatment:

Behavioral: Algorithm

Control

Active Comparator group

Description:

Control sites received staff education for pain assessment and management comprised of four one-hour classes

Treatment:

Behavioral: Algorithm