Determining Feasibility of a Model of Care for Secondary Fracture Prevention

Determining Feasibility of a Model of Care for Secondary Fracture Prevention for Implementation in Health Care System in Pakistan After Hip Fracture: a Clinical Outcome Study

Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. These 'minimal trauma fractures' (also known as 'osteoporotic', 'low trauma' or 'fragility' fractures) are the hallmark of a chronic and disabling disease that affects both men and women worldwide. On statistical grounds, more than 50 % of postmenopausal women and 30 % of men over the age of 60 years will suffer at least one minimal trauma fracture during their remaining lifetime. Any osteoporotic fracture predisposes to further fractures, significant morbidity and premature death. Thus, following a first minimal trauma fracture both men and women have a two- to threefold increased risk of subsequent fracture.

This study aims to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C & D model as proposed by Ganda et al at the Aga Khan University, with collaboration of the departments of Orthopaedics, Chemical Pathology, Family Medicine and Internal Medicine.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Diagnostic test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan

Detailed Description

With the severity of implications associated with fragility fractures, prevention of a secondary fracture has become a primary focus from a patient care and societal standpoint worldwide. However, this area has been so far neglected in Pakistan. A fracture requires that two conditions occur simultaneously: week bones and a fall or stress on week bones and a co-management approach is required to address both issues.

The investigators propose to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C & D model as proposed by Ganda et al. Based on this study the investigators will propose a model of care for SFP for application at national level in private and public sector. The long-term plan is to develop a national fragility fracture network in preventing and managing fragility fractures and to promote research aimed at better treatments of osteoporosis, sarcopenia and fracture in line with global CtA from FFN. This information will also help us in applying clinical practice guidelines for osteoporosis and driving policy change for our country which is currently non-existent and is likely to be a step towards the achievement of Sustainable Development Goals (SDG) (i.e. ensure healthy lives and promote wellbeing for all at all ages) and in line with WHO decade of healthy ageing 2021-23.

Specific Aims:

This study is primarily aimed at comparison of the feasibility and effectiveness of models of care (Type A, B, C & D) for hip fracture patients. The Specific, Measurable, Achievable, Realistic, and Time-defined (SMART) goals of this project are formulated around the 5IQ approach delineated by the Royal Osteoporosis society based on the following 6 parameters.

I. Identification: systematic screening of high-risk individuals

II. Investigation: undertaking of relevant investigations to delineate the cause of low bone mass

III. Information: educating patients on falls prevention and fracture risk

IV. Initiation: provision of pharmacological, lifestyle, dietary, conservative management approach and falls prevention interventions according to the model of care adopted

V. Integration: promotion of integration between primary and secondary care

VI. Quality: Ensuring professional development, audit, and peer-review activities

Type A model: Intensive service with all routine interventions:

Participants will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment.

Comprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form.

Type B model: All intervention except treatment initiation-the responsibility of participants general practitioner for prevention of secondary fracture Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Participants will be followed at 6 months on telephone, and a questionnaire related to treatment compliance &/or non-compliance will be filled by the coordinator.

Type C model: Health education only provided at the time of admission with handover to family physician for follow-up. Participants will be given an appointment to follow-up at community health center of Aga Khan University.

Type D model: Health Education provided. There is no physician contact with the participant's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to the participant along with counselling by the nurse at the time of discharge.

• Study Type: Observational
• Enrollment (Anticipated): 172

Contacts and Locations

• Study Contact: Name: Sibtain Ahmed; Phone Number: 1951 +922134861951; Email: sibtain.ahmed@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Recruiting
      • Aga Khan University
      • Contact: Sibtain Ahmed; Phone Number: 02134861951; Email: sibtain.ahmed@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting with low trauma hip fractures at the out-patients or at emergency department

Description

Inclusion Criteria:

• All women ≥50 years with low trauma hip fracture
• All post-menopausal women ( less than 50 years) with low trauma hip fracture
• Men ≥50 years with low trauma hip fracture

Exclusion Criteria:

• Patients with high impact hip fracture including after road traffic accident

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Model A; Patients will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment. Comprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form (12).	Diagnostic test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan; investigations for secondary causes of osteoporosis
Model B; All routine intervention except treatment initiation-the responsibility of patient's general practitioner for prevention of secondary fracture. Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Patients will be followed at 6 months on telephone, and a questionnaire related to treatment compliance &/or non-compliance will be filled by the coordinator.	Diagnostic test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan; investigations for secondary causes of osteoporosis
Model C; Health education only provided at the time of admission with handover to family physician for follow-up. Patients will be given an appointment to follow-up at community health center of Aga Khan University	Diagnostic test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan; investigations for secondary causes of osteoporosis
Model D; Health Education provided. There is no physician contact with the person's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to patient along with counselling by the nurse at the time of discharge	Diagnostic test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan; investigations for secondary causes of osteoporosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary fracture prevention of hip	Rate of Secondary fracture of hip (occurrence of hip fracture (n) if any during the follow up will be noted)	1 year of follow-up
Total Secondary fracture prevention	Rate of total fracture (occurrence of fracture (n), if any, during the follow up will be noted)	1 year of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the models of care- Follow up plan	On a Likert's scale of 1 to 5, rating will be recorded from the participants for: The plan for follow-up was explained to the participant clearly	1 year of follow-up
Effectiveness of the models of care- Care provided post fracture	On a Likert's scale of 1 to 5, rating will be recorded from the participants for: Participant is satisfied with the care provided post fracture.	1 year of follow-up
Effectiveness of the models of care- Adequacy of information provided	On a Likert's scale of 1 to 5, rating will be recorded from the participants for: right amount of information was given to the participant for secondary fracture prevention	1 year of follow-up
Effectiveness of the models of care- Communication	On a Likert's scale of 1 to 5, rating will be recorded from the participants for: The plan for managements for secondary fracture prevention was communicated adequately	1 year of follow-up

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: prevention; fracture; Hip fractures
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2020-3409-14191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No