Trial Outcomes & Findings for Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (NCT NCT01130740)

Last Updated: 2015-04-28

Results Overview

Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from "none" (0) to "severe / extreme" (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

12-months

Results posted on

2015-04-28

Participant Flow

Primary care providers in the Durham VA Ambulatory Care Service and their patients were recrutied from this study. Recruitment began on August 4, 2011 and was completed on December 30, 2012.

Participant milestones

Participant milestones
Measure	Usual Care Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Overall Study STARTED	149	151
Overall Study COMPLETED	137	136
Overall Study NOT COMPLETED	12	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=149 Participants Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention n=151 Participants Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.	Total n=300 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 9.0 • n=5 Participants	60.4 years STANDARD_DEVIATION 9.4 • n=7 Participants	61.1 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	20 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	131 Participants n=7 Participants	272 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	65 Participants n=5 Participants	69 Participants n=7 Participants	134 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	67 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)	47.8 units on a scale STANDARD_DEVIATION 17.4 • n=5 Participants	48.9 units on a scale STANDARD_DEVIATION 17.6 • n=7 Participants	48.4 units on a scale STANDARD_DEVIATION 17.5 • n=5 Participants
Short Performance Physical Test	8.1 units on a scale STANDARD_DEVIATION 2.48 • n=5 Participants	8.0 units on a scale STANDARD_DEVIATION 2.63 • n=7 Participants	8.0 units on a scale STANDARD_DEVIATION 2.6 • n=5 Participants
Patient Health Questionnaire 8 (PHQ-8)	6.4 units on a scale STANDARD_DEVIATION 5.13 • n=5 Participants	7.2 units on a scale STANDARD_DEVIATION 5.57 • n=7 Participants	6.8 units on a scale STANDARD_DEVIATION 5.36 • n=5 Participants

PRIMARY outcome

Timeframe: 12-months

Population: All enrolled participants were analyzed, on an intent to treat basis. One enrolled participants in the Usual Care grouped changed clinical care to an enrolled OA Intervention provider after randomization, so that participant was analyzed with the OA intervention group.

Outcome measures

Outcome measures
Measure	Usual Care n=149 Participants Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention n=151 Participants Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Common Baseline	48.4 units on a scale Standard Error 1.09	48.4 units on a scale Standard Error 1.09
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) 6-Month	43.5 units on a scale Standard Error 1.45	41.2 units on a scale Standard Error 1.47
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) 12-Month	48.5 units on a scale Standard Error 1.38	44.4 units on a scale Standard Error 1.39

SECONDARY outcome

Timeframe: 12-months

This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance). The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

Outcome measures

Outcome measures
Measure	Usual Care n=149 Participants Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention n=151 Participants Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Short Physical Performance Test Protocol Common Baseline	8.01 units on a scale Standard Error 0.149	8.01 units on a scale Standard Error 0.149
Short Physical Performance Test Protocol 12 Months	7.53 units on a scale Standard Error 0.233	7.86 units on a scale Standard Error 0.237

SECONDARY outcome

Timeframe: 12-months

This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

Outcome measures

Outcome measures
Measure	Usual Care n=149 Participants Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention n=151 Participants Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
PHQ-8 Common Baseline	6.83 units on a scale Standard Error 0.31	6.83 units on a scale Standard Error 0.31
PHQ-8 12 Months	6.83 units on a scale Standard Error 0.39	6.21 units on a scale Standard Error 0.39

Adverse Events

Usual Care

Serious events: 18 serious events

Other events: 9 other events

Deaths: 0 deaths

Osteoarthritis Intervention

Serious events: 25 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Kelli D. Allen, PhD

Center for Health Services Reserach in Primary Care, Durham VAMC

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Usual Care n=149 participants at risk Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention n=151 participants at risk Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Blood and lymphatic system disorders Hospitalization	3.4% 5/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	4.0% 6/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Gastrointestinal disorders Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	4.0% 6/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Hepatobiliary disorders Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.66% 1/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Infections and infestations Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	1.3% 2/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Injury, poisoning and procedural complications Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	6.6% 10/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Musculoskeletal and connective tissue disorders Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.66% 1/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Musculoskeletal and connective tissue disorders Outpatient Surgery	1.3% 2/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.00% 0/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Musculoskeletal and connective tissue disorders Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.00% 0/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	1.3% 2/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Nervous system disorders Hospitalization	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.00% 0/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Psychiatric disorders Hospitalization	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.00% 0/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Renal and urinary disorders Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.66% 1/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Respiratory, thoracic and mediastinal disorders Hospitalization	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.0% 3/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Surgical and medical procedures Hospitalization	3.4% 5/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	7.3% 11/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Surgical and medical procedures Outpatient Surgery	4.0% 6/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	4.6% 7/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.

Measure	Usual Care n=149 participants at risk Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.	Osteoarthritis Intervention n=151 participants at risk Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Blood and lymphatic system disorders Emergency Room Visit	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	1.3% 2/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Cardiac disorders Emergency Room Visit	1.3% 2/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.0% 3/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Ear and labyrinth disorders Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.66% 1/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Endocrine disorders Emergency Room Visit	2.0% 3/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.0% 3/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Eye disorders Emergency Room Visit	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.66% 1/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Gastrointestinal disorders Emergency Room Visit	1.3% 2/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	3.3% 5/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
General disorders Emergency Room Visit	1.3% 2/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.6% 4/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Infections and infestations Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.6% 4/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Injury, poisoning and procedural complications Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.0% 3/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Musculoskeletal and connective tissue disorders Emergency Room Visit	2.7% 4/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	14.6% 22/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Emergency Room Visit	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	2.0% 3/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Nervous system disorders Emergency Room Visit	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	4.0% 6/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Psychiatric disorders Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	1.3% 2/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Renal and urinary disorders Emergency Room Visit	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	5.3% 8/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Reproductive system and breast disorders Emergency Room Visit	0.00% 0/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.66% 1/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Respiratory, thoracic and mediastinal disorders Emergency Room Visit	2.0% 3/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	7.3% 11/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Skin and subcutaneous tissue disorders Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	1.3% 2/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.
Surgical and medical procedures Emergency Room Visit	0.67% 1/149 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.	0.00% 0/151 • For each participant, the collection period was 1 year: baseline to 12-month follow-up.